Efficacy and safety of combined Baduanjin-auricular acupressure treatment for the postoperative rehabilitation of patients with non-small cell lung cancer: protocol for a randomized controlled trial

Abstract

Background

Active participation in postoperative pulmonary rehabilitation training is an indispensable part of the rehabilitation process for patients with lung cancer and is critical to improving the quality of life (QOL). Baduanjin or auricular acupuncture can significantly improve exercise tolerance, fatigue, and QOL in patients with lung cancer. Baduanjin promotes physical function and psychological well-being through gentle movement and breathing control, while auricular acupressure may further alleviate symptoms by modulating neuroendocrine pathways. Their integration could address multidimensional impairments (physical, emotional, and symptom-related) more comprehensively than either intervention alone. Current rehabilitation programs often lack accessible, low-cost adjunct therapies. The combination offers a feasible, patient-centered approach—Baduanjin provides structured exercise, and auricular acupressure requires minimal resources, making it suitable for home-based care. However, there is a paucity of research addressing the joint effects of the combined intervention of Baduanjin and auricular acupressure. Therefore, in this study, we aim to assess the efficacy of the combined intervention of Baduanjin and auricular acupressure as an alternative regimen for postoperative rehabilitation in patients with lung cancer.

Methods

This four-arm parallel randomized controlled trial will randomize 236 lung cancer surgery patients (1:1:1:1) to: (I) Baduanjin plus auricular acupressure (BG + AAG), (II) Baduanjin group (BG), (III) auricular acupressure group (AAG), or (IV) control group (CG). Primary outcomes [6-minute walk distance (6MWD), cancer-related fatigue scale, and QOL core scale] will be assessed at baseline, 4 and 12 weeks by blinded evaluators. Secondary analysis of 6MWD at 6 months will compare BG + AAG versus CG. Treatment effects will be analyzed using repeated-measures ANOVA with intention-to-treat principle.

Discussion

The four-arm, randomized controlled trial design of the study can enhance both the scientific rigor and reliability of the experiment. Its application can provide clear results and generalizable conclusions for researchers and thus help form a theoretical basis for developing alternative traditional Chinese medicine (TCM) therapy for the postoperative rehabilitation of patients with lung cancer.

Trial Registration

China Clinical Trial Registry (No. ChiCTR2400085060, 30 May 2024).

Introduction

Background and rationale

According to the Global Cancer Observatory estimates, lung cancer accounted for 22.6% (~787,000) of all new cancer cases and 26.1% (~631,000) of all cancer-related deaths in China in 2020 (1). The high incidence and mortality rates of lung cancer contribute heavily to the global disease burden, making it a significant public health concern worldwide (2). Video-assisted thoracoscopic surgery has demonstrated substantial benefits in reducing surgical trauma, shortening hospital stays, and improving overall surgical safety (3). However, Brown et al. (4) found that patients diagnosed with non-small cell lung cancer exhibit diminished activity tolerance for a period ranging from 6 months to 2 years postoperatively. The most prevalent symptoms include pain, fatigue, dyspnea, and cough. Of particular note, dyspnea and fatigue persist for a period of at least 2 years postoperatively. This phenomenon may be related to the inflammatory response and physical damage to the lung structure caused by thoracoscopic surgery that stimulates lung parenchyma during surgery, resulting in decreased lung capacity and cardiopulmonary fitness (5), significantly worsening postoperative quality of life (QOL) and survival rates. Consequently, issues such as the recovery of lung function, enhancement of activity tolerance, alleviation of fatigue symptoms, and improvement in the QOL of patients with lung cancer following surgery warrant further attention.

According to the 2013 American Thoracic Society (ATS) and European Respiratory Society (ERS) guidelines, pulmonary rehabilitation has demonstrated significant benefits for patients with lung cancer (6). Studies have confirmed that pulmonary rehabilitation programs can effectively improve the lung function, exercise tolerance, and dyspnea symptoms of patients after thoracoscopic surgery, especially during postoperative pulmonary rehabilitation (7,8). A growing body of evidence also suggests that the technical interventions of traditional Chinese medicine (TCM), such as qigong [tai chi (9,10), Baduanjin (11,12), six-character ji (13), etc.], acupuncture (14), auricular acupressure (15), and acupoint application (16), may be beneficial in improving lung function, activity tolerance, fatigue, and QOL in patients with respiratory disorders. In recent years, TCM as an adjuvant treatment measures has become an area of intense clinical research focus. Many clinicians actively combine TCM qigong and acupuncture to achieve better therapeutic effects. Thus, it is worth assessing the synergistic effect of Baduanjin and auricular acupressure as an alternative rehabilitation programs for patients with lung cancer after surgery.

In TCM, the lungs are considered vital organs responsible for the intake of qi from the environment and for the distribution of this energy throughout the body. A deficiency in lung qi can lead to various health problems, including respiratory issues, fatigue, and a weakened immune system (17). Lung surgery has the potential to cause damage to lung qi, which can subsequently reduce normal lung function (18). This, in turn, may result in an insufficient qi and blood supply throughout the body. Consequently, individuals diagnosed with lung cancer are susceptible to impaired lung function, diminished tolerance for physical exertion, and fatigue following surgical intervention (18).

Previous research by Bullard et al. (19) demonstrated through a retrospective study that among chronic pulmonary disease patients undergoing rehabilitation, lung cancer patients showed the lowest adherence rates to postoperative rehabilitation training. This phenomenon primarily stems from the high costs associated with the requirement for specialized equipment and professional supervision in conventional postoperative rehabilitation programs (20). Therefore, the primary objective of our study is to identify an effective, low-cost intervention strategy that can enhance active participation in postoperative rehabilitation among non-small cell lung cancer patients.

Baduanjin is a traditional Chinese exercise regimen that focuses on regulating the movement of body qi and blood through a series of gentle movements and breathing techniques. It is deeply rooted in the principles of TCM, which emphasizes the importance of balancing the body’s energy (21). Meanwhile, auricular acupuncture can regulate the function of viscera by stimulating the holographic reflex area of ear. Each point on the ear is believed to correspond to different organs and systems within the body, including the lungs. By applying pressure or stimulation to these auricular points, practitioners can help replenish lung qi, enhance respiratory function, and improve overall vitality (22). A substantial body of research has documented the positive impacts of the Baduanjin technique on patients with lung cancer who have undergone surgical intervention (23,24). These benefits include improvements in postoperative 6-minute walk distance (6MWD), alleviation of airway obstruction, enhancement of QOL, and reduction of anxiety. Xu et al. provided evidence that Baduanjin exercise and traditional pulmonary rehabilitation techniques can effectively enhance pulmonary function and QOL in patients with non-small cell lung cancer (24). In a comparative analysis, Liu et al. discovered that Baduanjin exercise was more efficacious than routine exercise in alleviating cancer-related fatigue (25). Meanwhile, Lin et al. (26) [2021] discovered that auricular acupuncture could potentially function as a valuable supplementary TCM therapy for individuals with advanced lung cancer undergoing immunotherapy, and it could effectively alleviate those symptoms associated with anxiety and pain. Practicing Baduanjin not only encourages deep breathing, which is essential for lung expansion and oxygenation, but also promotes relaxation and stress reduction, further supporting lung function. Its combination with auricular acupuncture can specifically target points that enhance lung qi and thus may provide a synergistic effect. The integrative application of Baduanjin exercise and auricular acupuncture embodies both the holistic philosophy of TCM, particularly the ‘internal-external synergy’ therapeutic principle, and contemporary medical concepts including regulation theory and the neuro-endocrine-immune network. This unique combinatorial intervention may offer a novel paradigm for elucidating shared mechanistic pathways between TCM and Western medicine.

However, there is a paucity of research addressing the joint effects of the combined intervention of Baduanjin and auricular acupressure. Therefore, the aim of this study is to evaluate the synergistic benefits of combining Baduanjin and auricular acupressure through the measure of 6MWD, cancer-related fatigue, and QOL in patients with lung cancer. The overall goal is to determine whether combined interventions can provide greater benefits and faster recovery as compared to single-mode interventions and to determine the viability of combined interventions as an alternative to active pulmonary rehabilitation. A four-group comparative study design will be used, combining subjective and objective evaluation measures. Data collectors will assess the 6WMD in the combined intervention group and the control group at 3 months after the end of the intervention to determine the long-term effects of the combined intervention. The objective is to determine the safety, efficacy, and convenience of this alternative method and to establish a theoretical basis for TCM pulmonary rehabilitation.

Objectives

The objective this randomized, single-blind, four-arm, parallel controlled trial is to evaluate the safety and synergistic effect of Baduanjin combined with auricular acupressure on the postoperative rehabilitation of patients with lung cancer. The 6MWD of a group treated with Baduanjin plus auricular acupressure (BG + AAG) and a control group (CG) will be measured on the third month after the intervention to evaluate the long-term effects of the combined intervention.

Trial design (8)

This single-center, single-blind, parallel-group, randomized controlled trial will recruit patients with lung cancer who will be scheduled for surgery at the Department of Thoracic Surgery, Tongji Hospital Affiliated to Tongji Medical College (TMC) of Huazhong University of Science and Technology (HUST). The patients will be randomly divided into four groups at a ratio of 1:1:1:1. We present this article in accordance with the SPIRIT reporting checklist (available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-966/rc) (27).

Methods

Study setting

This study will be conducted at the Department of Thoracic Surgery of Tongji Hospital affiliated with TMC of HUST, China.

Trial status

The version of the study (v. 1.0) was approved on May 30, 2024. Participants have not yet been recruited at the time of manuscript submission. Participant recruitment is expected to begin in June 1, 2024, and is expected to end in July 31, 2024. Data analysis is planned to begin in January 2025.

Eligibility criteria

Inclusion criteria

The inclusion criteria are as follows: (I) consecutive adult surgical candidates (age ≥18 years) admitted for the treatment of confirmed or suspected pulmonary malignancy (clinical stage IIIB or lower); (II) medically cleared for exercise and scheduled for surgery at least 2 weeks after baseline; (III) ability to independently, be conscious, and possess good comprehension and communication skills; (IV) no TCM rehabilitation, including acupuncture, qigong, or auricular acupuncture, in the past 3 months or no current participation in regular exercise (aerobic and resistance training in past month of ≥2 days/week at ≥30 min/session); and (V) voluntary agreement to take part in the study.

Exclusion criteria

The exclusion criteria are as follows: (I) contraindications to exercise rehabilitation, such as a recent heart attack or cerebrovascular disease, unstable angina, aneurysm, recent history of coughing up blood (within 90 days), severe cardiac dysrhythmia, or musculoskeletal or mental illness within the past year; (II) the surgical method was changed to total pneumonectomy during operation; (III) receiving other forms of TCM treatment (including TCM, acupuncture, etc.) after surgery; (IV) participation in similar care intervention studies; and (V) inflammation or damage to the skin of the auricle or allergies to medical tape.

Withdrawal criteria

The withdrawal criteria are as follows: (I) poor compliance and failure to participate in the Baduanjin or auricular acupuncture intervention training as specified after enrollment or an absence rate of 20% or higher; (II) participant-led withdrawal, loss to follow-up, or lack of regular follow-up visits or an active request to withdraw; and (III) occurrence of serious complications during the study and an inability to continue the study, transfer to another hospital for treatment, or death during the study.

Discontinuation criteria

The discontinuation criteria include symptoms such as rapid heartbeat, chest tightness, shortness of breath, ear skin allergy, or any condition hindering further participation or resulting in death.

Informed consent

Potential participants will be identified during routine appointments for pulmonary or thoracic surgery and will be invited to participate in the study by their primary care physicians. If deemed eligible, patients will be contacted by the research team, who will provide them with verbal and written information about the study. All patients who agree to participate in the study will be asked to sign an informed consent form prior to any study evaluation.

Interventions

Explanation for the choice of comparators

The patients will be randomly divided into the following four groups at a ratio of 1:1:1:1: the BG + AAG, Baduanjin group (BG), auricular acupressure group (AAG), and the CG. The program will be jointly conducted by the Department of TCM and the Department of Thoracic Surgery of Tongji Hospital, HUST (Wuhan, China). The intervention team will receive uniform and standardized training before the intervention, and the feasibility of the program will be pre-determined. Figure 1 provides the flowchart of patient inclusion in the study.

Figure 1.

Flowchart of participant inclusion. AAG, auricular acupressure group; BG, Baduanjin group; CG, control group; 6MWD, 6-minute walk distance; ITT, intention-to-treat.

Intervention description

Control group

The CG will undergo postoperative home rehabilitation and health education, including health knowledge education with postdischarge medication; precautions for follow-up visits; management of related symptoms, daily living, dietary care, and emotional care; rehabilitation exercise (aerobic exercise and resistance training); and respiratory muscle training (abdominal breathing and pursed-lip breathing). The detailed operations are shown in Table 1.

Table 1. Intervention components of the 12-week program.

Component	Frequency per week	Intensity	Time	Type	Implementor	Supervisory mode
Baduanjin group	30 minutes, 2 times a day, 4 days a week	Monitor training intensity using the Borg Category Ratio (Borg CR-10). The recommended RPE is 3-5 (medium to strong)	12 weeks	(I) Ten postures: (i) push up the sky to regulate “tri-jiao”; (ii) draw the bow on both sides like shooting a vulture; (iii) raise single arm up to regulate spleen (Pi) and stomach (Wei); (iv) look back to treat five strains and seven impairments; (v) swinging the head and lowering the body to clear heart fire; (vi) pull the toes with the hands to strengthen the kidneys (Shen) and lower back; (vii) clench one’s fist and glare to increase strength; (viii) rise and fall on tiptoe seven times to treat all diseases	Two trained Chinese medicine specialists	Video conference
				(II) Matters needing attention: when practicing, try to dress loosely, keep in mind that the posture is relaxed, do not force to practice when the body is not well, and do not exercise vigorously, take a bath, eat, etc.
Auricular acupressure group	Each point for 20–30 seconds, a total of 5 minutes, 3 times a day, change it every 5 days	Acid swelling pain on pressure	12 weeks	(I) Point selection: acupoints Shenmen, AT4 Subcortex, AH6a Sympathetic, CO18 Endocrine, CO14 Lung, and CO7 Colon	TCM therapist	Video conference
				(II) Matters needing attention: each point should be pressed for 20–30 seconds, for a total of 5 minutes, 3 times daily. The acupoints should be changed every 5 days over a 12-week period (e.g., from left ear to right ear, with the acupoints remaining the same)
Control group	Once a month	NA	12 weeks	(I) Educational session: after discharge, patients will receive an electronic manual for home rehabilitation, which includes: post-discharge drug guidance, diet guidance, life guidance, postoperative follow-up time, wound removal and nursing precautions, effective postoperative cough, wound pain and other symptoms management guidance	An assessor who doesn’t know about the group	Telephone
				(II) Home exercise training: Lip contraction breathing (2 times/day, 10 minutes/time) and simple deep breathing training (2 times/day, 15 minutes/time). At the same time, patients in the control group were encouraged to participate in competent physical activities
				(III) Telephone supervision: each of the four groups received weekly telephone calls from an evaluator who was unaware of their assigned grouping

NA, not applicable; RPE, rating of perceived exertion; TCM, traditional Chinese medicine.

BG

On the basis of the CG, after the research participants have been recruited, two qualified nurses from the TCM Department who have been trained in Baduanjin will provide one-on-one instruction in the thoracic surgery demonstration classroom until the participants have correctly mastered the 10 postures of Baduanjin (Figure 2) (28). Only those who can demonstrate mastery of the movements and smoothly complete the Baduanjin exercises according to the instructional videos will be eligible to participate in the study. Upon enrollment, participants will be informed that they may begin performing Baduanjin rehabilitation exercises at home starting the day after discharge. Sessions will be 30 minutes long and are expected to be performed 2 times a day and 4 days a week for a period of 12 weeks. Each training session will be supervised by two trained Chinese medical specialists and will consist of three phases: warm-up (5 minutes), eight-segment training (20 minutes), and cool-down (5 minutes). The instructional video used is from Fitness, published by the State General Administration of Sports, and focuses specifically on qigong Baduanjin. Throughout the intervention period, the nurse from the TCM Department will supervise the participants’ Baduanjin practice via videoconferencing and provide timely corrections for any incorrect movements. In addition, patients will be instructed on how to monitor the intensity via the Borg Category-Ratio (Borg CR-10) scale (29). The detailed operations are shown in Table 1.

Figure 2.

Ten postures of Baduanjin (28). (A) Preparation posture. (B) Prop up the sky with both hands to regulate the triple energizer. (C) Draw a bow on both sides as if shooting a vulture. (D) Raise a single arm to regulate the spleen (Pi) and stomach (Wei). (E) Look back to treat five strains and seven impairments. (F) Sway head and buttocks to expel heart (Xin) fire. (G) Pull toes with both hands to reinforce the kidney (Shen) and waist. (H) Clench fists and look with eyes wide open to enhance strength and stamina. (I) Rise and fall on tiptoes to dispel all diseases. (J) Ending posture. These images are published with the participant’s consent.

AAG

The selection of auricular points for the AAG will based on modern medical theories, and theories of TCM (30). Acupoint localization will be conducted according to the National Standard of the People’s Republic of China (GB/T13734-2008). The preliminary intervention program includes the following acupoints: Ear Shenmen (TG7). AT4 Subcortex, AH6a Sympathetic, CO18 Endocrine, CO14 Lung, and CO7 Colon. On the basis of the CG, after discharge, the group will be begun to perform auricular massage, pressing each point for 20–30 seconds, for a total of 5 minutes, 3 times a day. The cowherb seeds (Wang Bu Liu Xing) on the auricular points will be replaced every 5 days for a total duration of 12 weeks. The detailed operations are presented in Table 1. For the procedure, the researcher will be responsible for recruitment and will inform the TCM specialist nurse of the patient enrollment information. Subsequently, the TCM specialist nurse will conduct one-on-one consultations with the patients in the thoracic surgery demonstration classroom. The consultation will cover the mechanism of action for auricular pressure and the relationship between auricular point selection and postoperative recovery from lung cancer. In addition, the TCM specialist nurses will observe the patient’s ear condition, identify positive response points at the relevant acupoints, and explain the mechanisms behind these points in order to improve the patient’s compliance with the auricular acupressure intervention. The day before discharge, the nurse specializing in TCM will perform auricular pressure therapy on the patient.

BG + AAG

Based on the CG, participants in the joint intervention group will perform Baduanjin rehabilitation exercises in conjunction with ear point bean massage. The procedures for both the Baduanjin exercises and the ear point bean massage will be identical to those performed in their respective groups, with the entire intervention lasting a total of 12 weeks.

Telephone supervision

The patients in the BG + AAG, the BG, the AAG, and the CG will be supervised by telephone once a week by an uninformed evaluator.

Criteria for discontinuing or modifying allocated interventions

Participants may withdraw from this study at any time during the course of the study, and participants may also be barred from continuing this study if circumstances that make continuation of the study unsuitable arise, including severe deterioration, serious adverse events (AEs), poor compliance, and other problems.

Strategies to improve adherence to interventions

The duration of this study is 12 weeks. Since the patients’ routine postoperative outpatient follow-up time is 4 and 12 weeks after surgery, this study duration will be conducive to ensuring the integrity of data collection. Additionally, we will arrange four assistants who will not be involved in randomization or data analysis to monitor and ensure the compliance and safety of the participants. In addition, we will also record the participants’ reasons for missing follow-up and withdrawal in detail.

Relevant concomitant care permitted or prohibited during the trial

Participants will be allowed to maintain their regular routines regarding medication, daily activities, and scheduled physician visits throughout the study. However, during the intervention and evaluation period, participants should avoid engaging in any additional TCM interventions aside from Baduanjin and auricular acupressure.

Provisions for posttrial care

After the trial concludes, individuals who have benefited from the intervention and express ongoing interest will receive continued access to it. Additionally, individuals in the CG will have the option to receive the intervention if they demonstrate a need for it during the study.

Outcomes

Outcome measures

Demographic information (such as age, sex, height, weight, body mass index, marital status, education level, and smoking history), medical diagnosis, and outcome (type of lung cancer, stage, site of surgery, mode of surgery, and level of surgery), lung function [forced expiratory volume in 1 second as a percentage (FEV1%), forced vital capacity (FVC), and FEV1], length of hospital stay, and length of chest tube retention will be recorded at the initial assessment. Participants will be assessed before the intervention, at week 4, at week 12, and at week 24 after the intervention. The primary outcome will include 6MWD, and the secondary outcomes will include cancer fatigue score and QOL score. All the evaluation results of the included trials are shown in Table 2.

Table 2. Study assessment procedures and timetable.

Study assessment procedures	Time points	Study duration
		Eligibility		Allocation		Post-allocation
		−T1		T0		T1	T2	T3
		Post-operation		Admission day (one day prior to discharge from hospital)		Intervention period (weeks 4)	End of intervention (weeks 12)	End of follow-up (weeks 24)
Enrollment	Eligibility screen	×
	Informed consent	×
	Randomization			×
Assignment	BG + AAG
	BG
	AAG
	CG
Assessments	Baseline data
	Demographics	×
	Clinical characteristics	×
	Surgery-related variables	×
	Primary outcomes
	6-minute walk distance	×				×	×	×
	Secondary outcomes
	Cancer-related fatigue scale	×				×	×
	Quality of life core scale	×				×	×

“×”: indicates that a specific procedure or assessment is performed at a discrete time point; “→”: represents a continuous or repeated process spanning multiple time intervals. AAG, auricular acupressure group; Borg CR-10, Borg Category-Ratio; BG, Baduanjin group; CG, control group.

Primary outcome

Six-minute walking distance

The test method for 6-minute walking test (6MWT) is as follows: The evaluator will employ the guidelines of the American Thoracic Society (31) to conduct the test. A section of corridor that is hard, straight, flat, and quiet, with a return length of 30 meters will be used for the test. At the start of the test, the patient begins walking as quickly as possible from the starting point and turns around at the 30-meter endpoint, and the number of cycles is recorded each time the patient returns to the starting point. If the patient’s condition allows, the test should be repeated at least 30 minutes later, with the highest value from the two trials recorded as the result. Before and after the trial, the Modified Medical Research Council score and pulse oxygen saturation and pulse will be evaluated, and the patient’s 6MWD results will be calculated after the trial. The scoring standard for the 6MWT is as follows: 350 m, 0 points; 349–250 m, 1 point; 249–150 m, 2 points; and ≤149 m, 3 points (32).

Secondary outcomes

Chinese Cancer fatigue scale

This study will use the Chinese version of the Cancer Fatigue Scale (CFS), which was translated into Chinese by Zhang et al. in 2011 (33). The original scale, developed by Okuyama et al. (34) is specifically used to assess the symptoms of patients with cancer over the previous few weeks. The Chinese version of the CFS consists of 15 items divided into three dimensions: physical, emotional, and cognitive. The 5-point Likert scale is used to rate each item from 1 (strongly disagree) to 5 (strongly agree). The Chinese CFS has demonstrated good internal consistency (Cronbach α coefficient =0.86) and test-retest reliability (0.77). These results indicate that the Chinese CFS is reliable for assessing the fatigue levels of patients with cancer. Meanwhile, the dimension scores include physical dimension (0 to 28), emotional dimension (0 to 16), and cognitive dimension (0 to 16). The formula for these dimensions are as follows: physical = (sum of dimension items – 7), emotional = (20 – sum of dimension items), and cognitive = (sum of dimension items – 4). A higher total fatigue score (0–60) indicates greater fatigue severity.

QOL core scale

The QOL will be assessed using the Chinese version of the Functional Assessment of Cancer Therapy-Lung (FACT-L) QoL scale (v. 4.0) for patients with lung cancer. This rating system was developed by Cella et al. in the United States (35,36) and translated and introduced in 1997 by Chinese scientists, including Wan et al. (37). The scale consists of two components: the FACT-general (FACT-G) and lung cancer-specific modules. These comprise 36 items in five domains: physical status, social/family status, emotional status, functional status, and other related issues. The scoring system uses a rating scale that ranges from “none” to “very much”, with scores assigned from 0 to 4. Positive items are scored in the forward direction, while negative items are scored in the reverse direction (38,39). The total score of the scale ranges from 0 to 144, providing a comprehensive assessment of QOL for patients with lung cancer. This scale has demonstrated high reliability and validity, with a test-retest reliability coefficient of 0.78 and a test-retest reliability and internal consistency (α) values for each domain greater than 0.7. A higher score indicates a better QOL for patients.

Exercise adherence

With reference to the relevant literature (40), we defined patients who attend more than or equal to 80% of the total number of interventions as compliant and patients who attend less than 80% of the total number of interventions as noncompliant. This will be based on the patient’s exercise diary (41,42).

Safety

Safety will be assessed by the direct description of the AEs associated with the intervention approaches.

Participant timeline

Table 2 illustrates the study assessment procedures and timeline.

Sample size

The sample size of this study will be calculated based on the main outcome index of the 6MWD. As evidenced by previous research (24), Baduanjin exercise significantly improved 6MWD in postoperative lung cancer patients, with the intervention group achieving 452.78±82.49 meters compared to 471.12±87.01 meters in controls (mean difference: 18.34 meters). Based on this effect size, a power analysis was conducted assuming a repeated-measures design with interaction effects, with α=0.083 and β=0.2 (power =80%). Using an established sample size calculation formula (43), we determined that 216 participants (54 per group) would be required. To account for an anticipated 10% attrition rate, the final target sample size was set at 236 cases.

Recruitment

Participants who diagnosed with non-small cell lung cancer will be recruited. The study aims to recruit at least 236 participants diagnosed with non-small cell lung cancer from May 01, 2024, to December 31, 2024. Participants will be screened primarily in thoracic surgery clinics, and we anticipate there will be sufficient enrollment to secure our sample size.

Assignment of interventions: allocation

Sequence generation

All participants will be uniformly distributed into the BG + AAG, BG, AAG, and CG through random distribution after baseline assessment. A researcher unaware of the intervention program will generate random numbers between 0 and 1 using a computer and sort them in ascending order. The first 59 numbers will be assigned to the BG, numbers 60 to 118 to the AAG, numbers 119 to 177 to the BG + AAG, and numbers 178 to 236 to the CG.

Concealment mechanism

Eligible patients will be randomly assigned at a 1:1:1:1 ratio to the BG + AAG, BG, AAG, and CG via a computerized random number generator (44). Allocations will be made by an independent researcher who is not involved in patient recruitment or data collection in sequentially numbered, opaque, sealed envelopes. Group allocation will be concealed until the baseline assessment is completed. At that time, the envelopes will be opened in numerical order. Outcome assessors will be blinded to group allocation and will be trained in the performance of outcome assessments. The envelopes will be stored in departmental filing cabinets that are inaccessible to the patients. The participants who have met the inclusion criteria and have provided signed informed consent will then be assigned to an intervention groups based on the order of enrollment and preset random grouping numbers.

Implementation

Information about the trial will be disseminated through thoracic surgeons and nurses, and research assistants will explain our program in detail to willing participants and recruit them. Participants who meet the inclusion criteria and sign informed consent to participate in the study will be assigned randomization codes and groups by professional researchers through a centralized randomization system. Professional nurses and therapists of TCM will treat patients according to their group allocation.

Assignment of interventions: blinding

Persons blinded

As the trial involves physical interventions, blinding of participants to the allocation is not possible. Data collection and statistical analysis will be conducted by an external researcher, who would be blinded to the intervention groups until the end of the intervention period.

Procedure for unblinding if needed

Unless the patient develops a serious AE or a serious deterioration in clinical condition, blinding will be maintained at all times, and in the event of urgent unblinding, the investigator will record the date and reason in the case report form. Thereafter, the samples and data will be anonymized and then analyzed. Thus, unblinding can only occur after all data have been analyzed and evaluated.

Data collection and management

Plans for assessment and collection of outcomes

The data collection staff will collect baseline information such as general demographics and medical history after the participants are enrolled. After the participants are randomized into groups, the data collection staff will fill in the relevant information of the participants in Microsoft Excel (Microsoft Corp., Redmond, WA, USA) for unified filing and saving. Before the participants visit the thoracic surgery clinic at 4 and 12 weeks after surgery, the data collection staff will make an appointment with the participants in advance to collect data on 6MWD, cancer-related fatigue, and QOL. At the third month after the 12-week intervention, the data collector will invite the participants to visit the TCM outpatient clinic by phone or WeChat to collect the 6MWD data of the participants.

Measures to promote participant retention and complete follow-up

Four training nurses will be responsible for supervising the participant group, with remote supervision completed via WeChat to facilitate participant retention and complete the follow-up. In addition, nurses will remind participants of the importance of adhering to the intervention plan. Participants will be given an allowance for public transportation to improve compliance with outpatient follow-up.

Data management

Data collection

Patient data will initially be obtained from the system’s electronic medical records and then uniformly imported into Microsoft Excel, where will be securely stored in Excel format. The data will be reviewed by two staff members not involved in the intervention to minimize potential human error. An independent data and safety monitoring board will be formed and will be responsible for monitoring the data and safety aspects of the trial.

Data security

Participants will be identified by participant codes, ensuring anonymity and confidentiality. Once quality assurance procedures are complete, the database will be locked for data entry purposes. All original materials will be stored in the medical record room at Tongji Hospital of HUST for 3 years under the supervision of the ethics committee.

Confidentiality

All data will be preserved for at least 5 years following the publication of the study. H.S. and C.Z. will be the custodian of the definitive trial dataset, and access to the trial data may be granted through contacting the corresponding author. The information of patients, including name, age, and telephone number, will be kept anonymous.

Statistical methods

Statistical methods for primary and secondary outcomes

Data will be entered and statistically analyzed with SPSS v. 24.0 (IBM, Armonk, NY, USA). Patients’ demographic characteristics, 6MWD, CFS score, QOL scale score, and other data will be analyzed according to the intention-to-treat (ITT) principle to minimize selection bias. Demographic and baseline characteristics will be outlined through descriptive statistics. For continuous variables, according to the results of normality test, if the data conform to normal distribution, they will be expressed as the mean ± standard deviation. If the data do not conform to a normal distribution, they will be expressed as the median and interquartile range. Count data will be described in terms of frequency and ratio (composition).

The primary statistical analysis will employ repeated-measures analysis of variance (RM-ANOVA) to assess intergroup effects. A two-tailed test will be used for the analysis, and the significance level will be set at α=0.05. The Mauchly sphericity test will be used to test the homogeneity of variance. If the Mauchly’s test of sphericity yields P>0.05, the assumption of sphericity is satisfied, and the standard RM-ANOVA may be applied. If P≤0.05, the sphericity assumption is violated, and corrections such as the Greenhouse-Geisser or Huynh-Feldt methods should be used for adjusted degrees of freedom. For cases in which the interaction effect is significant, simple effects analysis will be further performed.

The missing data will be processed by multiple interpolation to improve the accuracy and robustness of the estimates. For the analysis of data, the ITT principle will be followed, and some patients will be included in the final analysis even if they drop out or do not fully participate.

Methods in analysis to handle protocol nonadherence and any statistical methods to handle missing data

The missing data will be processed via multiple interpolation to improve the accuracy and robustness of the estimates. For the analysis of data, the ITT principle will be followed, and some patients will be included in the final analysis even if they drop out or do not fully participate.

Plans to provide access to the full protocol, participant level‑data, and statistical code

The trial has been registered with the China Clinical Trial Registry (No. ChiCTR2400085060). This proposal was approved by the Ethics Subcommittee of Tongji Hospital (TMC of HUST; no. TJ-IRB202404025). This study will be conducted in accordance with the Declaration of Helsinki and its subsequent amendments. Informed consent will be obtained from all participants and/or their legal guardians. Datasets for the current study will be made available from the corresponding author upon reasonable request.

Oversight and monitoring

Composition of the coordinating center and trial steering committee

Y.G., H.S., and C.Z. will be responsible for the preliminary design of the study and coordination of the team, overseeing the trial, and assuming medical responsibility for the patients. N.Z. and N.L. will be responsible for data collection to ensure data quality. Four research assistants (M.L., N.Z., C.L., and S.M.) will be responsible for recruiting participants. Investigators (X.H. and Y.Q.) will obtain informed consent and be responsible for patient randomization, physiological measurements, and data recording and follow-up. Two nurses of TCM and two TCM therapists (Y.G., M.P., P.Y., and C.L.) will be responsible for implementing the intervention plan for the participants. H.S. and Y.G. will manage trial registration, coordinate study visits, and prepare annual safety reports. Statisticians (Y.G. and H.S.) will provide advice on the statistical methods. The research team will meet once a month. No public or governmental organizations will be involved in this study.

Composition of the data-monitoring committee (DMC), its role, and reporting structure

The DMC, consisting of C.Z. and H.D., will conduct routine audits to ensure that data collection and coding is accurate and consistent. Y.G. will oversee data security each week, with secure storage planned for 5 years. Steering committee meetings will occur monthly to oversee trial execution and ensure data quality. All personnel will undergo comprehensive training, and meticulous documentation of participant recruitment, eligibility, consent, and data entry will be maintained. Moreover, regular quality control checks and data reviews will be conducted by the DMC to uphold data accuracy and completeness.

AE reporting and harm

Safety will be assessed through the collection of exercise-related AEs during weekly telephone calls. These AEs are defined as any unwanted or unexpected occurrence related to exercise that occurred during or within 24 hours after exercise” The Common Terminology Criteria for Adverse Events, fifth edition, will be used for the classification of the severity of these AEs. Serious AEs are defined as those that result in hospitalization, persistent or severe disability, or death (45). The DMC will be notified of any AEs classified as ≥ level 2 within 24 hours.

Frequency and plans for auditing trial conduct

The frequency of project tracking review will be 12 months, as requested by the Ethics Subcommittee of Tongji Hospital.

Plans for communicating important protocol amendments to relevant parties (e.g., trial participants and ethical committees)

When major modifications to the trial occur, any amendments to the protocol will be submitted by the principal investigator (H.D.) to the Ethics Subcommittee of Tongji Hospital for approval. If the revision involves trial participants, they will also be notified.

Dissemination plans

We will present the trial results at international and national conferences and publish them in scientific journals to reach a broad audience within the medical and research communities.

Discussion

TCM pulmonary rehabilitation is guided by the overall concept of TCM and syndrome differentiation and treatment theory, follows the characteristics of pulmonary diseases in TCM, uses TCM diagnosis and treatment knowledge to diagnose and treat patients with pulmonary diseases, is informed by the patient’s psychological state, and guides the patient to actively and passively participate in the treatment and prevention of pulmonary diseases, rehabilitation, and the process of improving mobility and QOL (46-48). TCM pulmonary rehabilitation comprises a set of comprehensive intervention measures that can stabilize or alleviate disease status, reduce medical costs, and promote long-term healthy behavior management for patients (47).

Research suggests that appropriate TCM techniques, such as auricular acupuncture, along with traditional practices such as Tai Chi (10,49), Baduanjin (50,51) and Liuzijue (13), show significant statistical improvements in respiratory disease, effectively relieving dyspnea symptoms, reducing fatigue symptoms, improved lung function, and improving QOL in patients with lung cancer. Xin et al. (52) proposed that TCM treatments such as auricular acupuncture can be performed at patients’ homes, reducing transportation and time costs for patients. Xu et al. (24) reported that Baduanjin qigong is a family-based, safe, and effective method for postoperative pulmonary rehabilitation. The combination of traditional treatment methods such as Baduanjin and auricular acupuncture with modern medical practice can further enrich the pulmonary rehabilitation process, effectively resolve phlegm, promote collateral circulation, tonify deficiencies, and significantly improve the overall health level and QOL of patients (21,53), while allowing them to achieve positive outcomes in pulmonary rehabilitation without requiring medical equipment or incurring additional expenses. Therefore, we designed a project for patients with lung cancer to use Baduanjin in combination with auricular acupuncture at home for active postoperative pulmonary rehabilitation. Through this combined intervention, we evaluated its efficacy in improving activity tolerance, enhancing postoperative lung function, alleviating fatigue, and improving overall QOL. In addition, we conducted follow-up evaluations of both the combined intervention group and the control group 3 months after the intervention to assess the long-term benefits of the combined approach.

To ensure the scientific rigor and reliability of the results, we will implement rigorous methods to minimize bias. This will include randomization, blinding of data collectors and evaluators, and the use of a four-arm parallel group design to mitigate selection bias in evaluating the efficacy of the intervention. In addition, we will use professional experimental equipment to collect objective data from the four groups, thereby enhancing the scientific integrity of the research.

The limitations to this study should also be mentioned. First, the participants in the study must be highly motivated, and to facilitate their visits to the TCM Department for the replacement of auricular pressure beans, we will inevitably introduce bias in the selection of participants. Second, despite the use of various strategies to avoid selection bias, the nature of the nonpharmacological intervention makes it difficult to blind researchers and participants to group assignments. Even with a thorough prior explanation of the purpose of the intervention and the study requirements to participants, it remains difficult to control for intervention bias.

In summary, this trial aims to evaluate whether different interventions can improve postoperative activity tolerance, improve lung function, reduce fatigue, and improve QOL in patients with lung cancer. If the intervention is found to be effective, the results will provide evidence supporting the use of TCM treatment methods for rehabilitation after surgery among patients with lung cancer, thereby demonstrating the efficacy of the TCM rehabilitation program. In future research, to provide more robust evidence on the efficacy of Baduanjin and auricular acupressure combination therapy for patients with lung cancer after surgery, further randomized controlled trials should be conducted with larger sample sizes and longer follow-up durations. In addition, we will plan to implement a preoperative rehabilitation program for patients with lung cancer that combines Baduanjin with auricular acupuncture which will aim to evaluate the efficacy of the TCM prerehabilitation program in improving lung function, especially in patients with compromised preoperative lung function. By improving pulmonary function, we hope to expand the surgical candidacy of patients who are currently ineligible for surgery due to poor pulmonary function.

Supplementary

The article’s supplementary files as

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. This study will be conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The Ethics Committee of Tongji Hospital (TMC of HUST) has reviewed and approved this research project (No. TJ-IRB202404025). All participants will be provided detailed information about the procedure, including its benefits and potential risks. Informed consent will be obtained from all participants and/or their legal guardians. Participation will be voluntary, and participants will be eligible to withdraw consent at any time without providing a reason, and this will not impact their medical care or have negative consequences. The participants will be provided a copy of their signed consent forms, while the original form will be retained in their personal records.