Effect of thera-band resistance training on diabetic patients with frailty syndrome

Abstract

Aims

Diabetes mellitus (DM) is one of the most common chronic diseases globally, and most patients suffer from a combination of frailty syndrome (FS) that severely affect their quality of life. To evaluate the effect of Thera-Band elastic band-assisted progressive resistance-exercise training (PRT) on the physical health of patients with DM complicated by FS, and to provide clinical evidence.

Methods

Patients with DM complicating FS who received Thera-Band elastic band PRT cases (study group, n = 48), and those who received conventional treatment (control group, n = 48) admitted to Zhejiang Rongjun Hospital from April 2023 to March 2024 were selected for randomized controlled trial (RCT). Blood glucose levels and body function before and after treatment were compared, and patients’ handgrip strength (HS) and usual gait speed (UGS) were measured. In addition, the fatigue, resistance, ambulation, illness, and loss of weight (FRAIL) scale and the Rating of Perceived Exertion (RPE) were used to assess patients’ frailty. Their psychological state was also investigated, and adverse reactions during treatment were counted.

Results

The research group showed lower blood glucose levels, as well as higher Short Physical Performance Battery (SPPB) scores and levels of HS and UGS than the control group after treatment (P < 0.05). In addition, the frailty status and psychological status of the research group were also demonstrated significant (P < 0.05), while the incidence of adverse reactions was not different from that of the control group (P > 0.05).

Conclusion

Thera-Band elastic band-assisted PRT may alleviate frailty in DM patients with FS and shows promise for clinical application.

Trial registration

www.clinicaltrials.gov ID NCT06658106 (Data 21/10/2024).

Introduction

Diabetes mellitus (DM), one of the most important chronic non-communicable diseases threatening global human health, has an incidence rate as high as 11.2% in China with more than 150 million cumulative cases [1]. The annual healthcare costs caused by DM are estimated to be over 109 billion US dollars, bringing a great burden to patients and their families [2]. The harm of DM lies in the malignant changes of various tissues and organs caused by persistent hyperglycemia, such as diabetic nephropathy and diabetic retinopathy. According to the World Health Organization, the death cases due to DM complications are second only to malignancies and heart diseases [3].

In the pathological progression of DM, the frailty syndrome (FS) is also one of the important links that can not be ignored. In 2004, the American Geriatrics Society defined FS as a non-specific state in which elderly individuals experience decreased stress resistance, increased vulnerability, and elevated susceptibility to diseases due to decreased physiological reserves, involving physiological changes in multiple systems such as the neuromuscular, metabolic, and immune systems, which increases the possibility of death, disability, delirium, and falls, exacerbating anxiety or depression symptoms in the elderly, and leading to a significant decrease in quality of life and an increased risk of negative events [4]. The mutual influence and vicious cycle between DM and FS not only elevate the risk of poor prognosis in patients, but also increase the difficulty of treatment [5]. Clinically, it is suggested that in the management of DM patients complicated by FS, it is not only necessary to pay attention to pathological changes, but also to maintain and improve their physical function through exercise intervention, thus achieving dual treatment of DM and FS [6].

Progressive resistance-exercise training (PRT) is a commonly used exercise therapy in clinical practice. Unlike routine exercise training, PRT can accelerate the blood flow velocity of skeletal muscle and promote myofibrillar protein synthesis in muscle fibers until 24 to 48 h after training [7]. Thera-band elastic bands are a special scheme in PRT, which distinguish different sizes of resistance loads through different colored elastic bands, allowing the trainer to easily and quickly transition from one low-resistance load to the next high-resistance load as muscle strength increases, which not only provides positive feedback on the training effect, but also increases the motivation and fun of training and is suitable for the elderly [8]. Although Thera-band elastic band-assisted PRT has now been shown to help control blood glucose and improve prognosis in patients with type 2 diabetes mellitus (T2DM), we find that these studies are on the one hand older (e.g., Lima FF et al. conducted a randomized controlled trial on PRT in 2018, confirming that PRT can help to promote physical fitness in older adults [9]) and on the other hand they more often just focus on the change of patients’ muscle strength (e.g., Yamamoto Y et al.‘s study explored the effect of Thera-Band elastic band-assisted PRT on muscle strength in T2DM patients [10]), and did not further explore the full impact of PRT on patients. Frailty alters physiological responses to exercise, potentially requiring modified protocols. Current evidence gaps include optimal resistance dosing and safety thresholds for this vulnerable group.

With the deepening of research and the development of medical care, we believe that PRT now has higher scientific validity, and as DM combined with FS has become more and more common in the clinic, we need to confirm the effect of PRT on such patients as soon as possible. Accordingly, this study will analyze the application effect of Thera-Band elastic band-assisted PRT in DM patients with FS, providing more reliable reference and guidance for the clinical treatment of DM complicated by FS in the future.

Information and methodology

Sample size calculation

The sample-size calculation was based on the change in the primary outcome measure balance score. Based on the results of the previous pilot study, the standard deviation (S) of the change in balance score between the research and control groups was expected to be approximately 2 points, and the between-group difference (δ) of 1.5 points was considered clinically significant. The significance level (α) was set at 0.05 (two-sided), and the test power (1-β) was 90%. Let’s plug in N = 2×[(1.96 + 1.282)×2/1.5]²=37.37, with α (two-sided) = 0.05 and β = 0.1, it was found that tα/2 = 1.96 and tβ = 1.282. Considering the loss rate of 20%, n was calculated to be 48, that is, the final sample size was determined to be 48 cases in each group.

Study population

96 patients with DM combined with FS who underwent Thera-Band elastic band-assisted PRT at Zhejiang Rongjun Hospital from April 2023 to March 2024 were randomly selected as the study subjects. The randomized controlled trial was conducted with the use of sealed, opaque, sequentially numbered envelopes to randomized controlled trial (RCT) (research group vs. control group, 48 each) (Fig. 1). All outcome assessors and statistical analysts were unaware of the group assignments. The Zhejiang Rongjun Hospital’s Ethics Committee approved the research (2023-(8)), and all the subjects signed informed consent forms, and The study protocol was registered prospectively on ClinicalTrials.gov (NCT06658106). In addition, this study was conducted following the Declaration of Helsinki.

Fig. 1.

Design flow of this study

Inclusion and exclusion criteria

Inclusion criteria: In accordance with the diagnostic guidelines of DM [11], with a diagnosis of T2DM, fasting blood glucose (FPG) < 16.7 mmol/L, Tilburg Frailty Indicator (TFI) [12] ≥ 4 points, age ≥ 60, and no gender restrictions; muscle strength [13] ≥ level 4; no habit of regular exercise in the past. Exclusion criteria: Cardiovascular diseases such as severe myocardial ischemia, cardiac insufficiency, and vascular embolism; disturbances of consciousness (such as drowsiness and coma); severe Alzheimer’s disease; patients with comorbid neurologic complications; physical disability; severe osteoporosis; poor medication adherence; inability to understand and cooperate due to communication barriers.

Methods

Both groups were given routine treatment for DM (treatment regimens were consistent). The control group received basic health education and guidance, covering diet, exercise, medicine, daily care, and health knowledge. The research group received Thera-Band elastic band-assisted PRT. Training was started one hour after breakfast every Monday, Wednesday, and Friday for 50 min, lasting for 12 weeks (Fig. 2). (1) Upper arm muscles: The patient was instructed to step on the elastic band with both feet in the sitting position, hold the band with hands, and bend the arms. The elastic band was pulled from the thigh plane (and both sides of the buttocks) towards the chest and then slowly lowered after reaching the highest. (2) Shoulder muscles: In the sitting position, the left arm was straightened to fix the elastic band, and the right arm pulled the band backward as far as possible like drawing a bow and shooting an arrow, and then slowly relaxed 5 s later. (3) Musculus pectoralis dorsi: After wrapping the elastic band around the hands in the sitting position, the hands were pulled from the front to both sides (up to the front of the head) to the maximum and then slowly lowered. (4) Lumbar muscles: After fixing the elastic band on the right foot, the band was tightened with the left hand, and the waist was crossed with the right hand. Then, using the spine of the body as the axis, the elastic band was pulled with the left hand to turn the body to the left rear and stretch the right waist muscles. (5) Lower limb muscles: The elastic band was fixed with the left foot and then fixed on the chest with both hands, after which left leg kick and flexion were carried out. Each exercise was conducted in 2–3 sessions, 8–12 times per session, with 1-minute intervals. Exercise intensity was set at 50–70% of heart rate reserve (HRR) with real-time pulse oximetry monitoring.

Fig. 2.

Photograph of a patient undergoing Thera-Band elastic band-assisted PRT. Male, 75 years old

Endpoints

(1) FPG, 2-hour postprandial blood glucose (2hPG), and glycosylated hemoglobin (HbA1c) were detected with a blood glucose meter before and after treatment. (2) Patients’ physical function was assessed using the Short Physical Performance Battery (SPPB) [14] from three subscales: balance test, walk test, and sit-to-stand test. The higher the score, the better the body function. In addition, the handgrip strength (HS) was detected with an electronic hand-muscle developer, and the usual gait speed (UGS) was measured by the 6-minute walk test. (3) The fatigue status was evaluated with the Rating of Perceived Exertion (RPE) [15], with the score being proportional to the patient’s subjective fatigue sensation; The fatigue, resistance, ambulation, illness, and loss of weight (FRAIL, α = 0.87) scale [16] were used to evaluate the patient’s frailty status (0–5 points), with 0 being robust, 1–2 being pre-frailty, and 3–5 being frailty. (4) Patients were assessed for their psychological states using the Geriatric Depression Scale-15(GDS-15, α = 0.73) [17] and Diabetes Distress Scale (DDS, α = 75) [18]; higher scores of both scales suggest more obvious the patients’ depression and distress. (5) The adverse events in the course of treatment, such as sports injuries and muscle strains, were counted to calculate the total incidence.

Statistical analysis

Statistical analyses were performed using SPSS 24.0 (IBM, USA). Count data were presented as percentages, and chi-square tests were used for comparisons. For measurement data, a Shapiro-Wilk test was performed first to confirm the normal distribution. Compliance with normal distribution was expressed as mean ± standard deviation, and comparisons were made using the independent samples t test and the paired t test; noncompliance with normal distribution was expressed as median (interquartile spacing), and comparisons were made using the Mann-Whitney U test and the Willcoxon rank sum test. Statistical differences were indicated by P < 0.05.

Results

Comparison of clinical data

First of all, age, sex, course of disease, and other clinical data of the two groups were compared, and no statistical significance was found (P > 0.05, Table 1), indicating comparability.

Table 1.

Comparison of clinical data

Groups (n = 48)	Control	Research	t (x2)	P
Age	66.88 ± 4.62	65.19 ± 5.02	1.713	0.09
Duration of DM (years)	7.98 ± 2.51	7.48 ± 4.02	0.731	0.467
Male	22 (45.83)	26 (54.17)	0.667	0.414
Female	26 (54.17)	22 (45.83)
BMI (kg/m2)	24.73 ± 3.52	23.94 ± 3.99	1.025	0.308
Chronic smoker	14 (29.17)	10 (20.83)	0.889	0.346
Non-smoking	34 (20.83)	38 (79.17)
Chronic drinking	12 (25.00)	15 (31.25)	0.464	0.496
Non-drinking	36 (75.00)	33 (68.75)
TFI	8.38 ± 2.57	8.15 ± 2.76	0.421	0.674
Combined hypertension	22 (45.83)	18 (37.50)	0.686	0.408

Comparison of blood glucose levels

The two groups were not statistically different in pre-treatment blood glucose test results (P > 0.05). After treatment, FPG, 2hPG, and HbA1c in both groups decreased (P < 0.05), with their levels in the research group being 6.13 (4.97–7.29) mmol/L, 8.06 (4.65–11.47) mmol/L, amd 8.16 (5.65–10.67) %, respectively, all of which were reduced compared to the control group (P < 0.05, Fig. 3).

Fig. 3.

Comparison of blood glucose (n = 48). (a) comparison of FPG, (b) comparison of 2hPG, (c) comparison of HbA1c. vs. before treatment ^*P < 0.05, vs. control group ^#P < 0.05

Comparison of body functions

In terms of SPPB scores, the scores of balance test, walk test, and sit-to-stand test in the research group after treatment were 3.65 (1.73–5.57), 3.50 (2.36–4.64), and 3.31 (2.15–4.47), respectively, which were higher compared to the pre-treatment scores and those of the control group (P < 0.05). In addition, the after treatment HS and UGS were 24.94 (17.18–32.70) kg and 0.82 (0.58–1.06) m/s in the research group compared to 22.72 (14.80-30.64) kg and 0.73 (0.46-1.00) m/s in the control group. The after treatment HS and UGS in the research group were more higher than those in the control group when compared to the two groups (P < 0.05, Fig. 4).

Fig. 4.

Comparison of body functions (n = 48). (a) comparison of balance score, (b) comparison of walk score, (c) comparison of sit-to-stand score, (d) comparison of HS, (e) comparison of UGS. vs. before treatment ^*P < 0.05, vs. control group ^#P < 0.05

Comparison of frailty

There was also no inter-group difference in pre-treatment FRAIL and RPE scores. A reduction in the scores of FRAIL and RPE was observed in both groups after treatment (P < 0.05), with even lower scores in the research group (P < 0.05, Fig. 5).

Fig. 5.

Comparison of frailty (n = 48). (a) comparison of FRAIL score, (b) comparison of RPE score. vs. before treatment ^*P < 0.05, vs. control group ^#P < 0.05

Comparison of psychological status

The survey results of psychological status showed that the DDS and GDS-15 of both groups decreased after treatment, with a more significant decrease in the research group compared to the control group (P < 0.05, Fig. 6).

Fig. 6.

Comparison of psychological status (n = 48). (a) comparison of DDS score, (b) comparison of GDS-15 score. vs. before treatment ^*P < 0.05, vs. control group ^#P < 0.05

Comparison of safety

Finally, the statistical results of adverse reactions revealed that the total incidence of adverse reactions in the research group was 12.50%, which had no difference compared with 6.25% in the control group (P > 0.05, Table 2), indicating the high safety profile of Thera-band elastic band-assisted PRT.

Table 2.

Comparison of safety

Groups (n = 48)	Control	Research	x2	P
Falls	1 (6.25)	2 (4.17)
Sports injuries	0 (0.0)	1 (6.25)
Arrhythmia	1 (6.25)	1 (6.25)
Elevated blood pressure	1 (6.25)	1 (6.25)
Dyspnea	0 (0.0)	1 (6.25)
Total Incidence	6.25	12.5	1.103	0.294

Discussion

As the global aging problem becomes more and more serious, the incidence of DM complicated by FS also shows an increasing trend year by year [19]. Exercise has been recognized by an increasing number of scholars because of its safety, few side effects, and good efficacy. For elderly patients with DM, exercise can effectively control blood glucose, enhance muscle strength, delay the decrease of muscle mass and the loss of calcium, and increase bone mineral density while exerting beneficial effects on the cardiopulmonary, skeletal, and neuroendocrine systems, thus inhibiting the progression of FS [20].

Thera-Band elastic band-assisted PRT uses elastic bands’ elastic resistance to complete the training of most muscles in the whole body to enhance the motor function of muscles, joints, and ligaments, with advantages such as strong operability, low sports risk, and low price [21]. In this study, we found that Thera-Band elastic band-assisted PRT enhanced the health of DM patients with FS, laying a reliable foundation for their rehabilitation.

First of all, comparing the blood glucose of the two groups, it was found that FPG, 2hPG, and HbA1c of both groups decreased after treatment, especially in the research group, suggesting that Thera-Band elastic band-assisted PRT has a more significant effect on controlling blood glucose, consistent with the research results of Lyu L et al. [22]. We believe that this is because Thera-Band elastic band-assisted PRT can accelerate the body’s blood glucose metabolism and reduce insulin resistance [23]. At the same time, exercise promotes the activity of lipid metabolizing enzymes and improves the muscle’s ability to take up and utilize glucose, thus effectively reducing the level of blood glucose [24]. Rodriguez-Mañas et al. also pointed out that with the increase in exercise amount and intensity, the blood glucose level and insulin sensitivity of DM patients improved more significantly [25].

Subsequently, in the comparison of body function and frailty status, the research group had higher SPPB, HS, and UGS after treatment, as well as lower FRAIL and RPE, indicating that Thera-Band elastic band-assisted PRT has an excellent improvement effect on patients’ physical health and can significantly alleviate their frailty. Clinical research has confirmed that the core pathological basis of FS is skeletal muscle atrophy [26]. However, DM interacts with FS, which is mutually causal and forms a vicious circle [27]. Thera-Band elastic band-assisted PRT integrates warm-up training, aerobic exercise, resistance exercise, balance training, and stretching training to form a comprehensive exercise training program, which can improve mitochondrial function, increase slow muscle fibers, promote protein synthesis of skeletal muscle cells [28], and enhance myofibrillar protein synthesis, thereby increasing the size and cross-sectional area of myofibrils, especially brachialis fibers, and maintaining skeletal muscle mass and function [29]. Balance training improves the patient’s balance ability and prevents adverse outcomes such as falls caused by frailty. The above comprehensive effects work together to enhance patients’ health and alleviate their frailty. In the research of Wang B et al., Thera-Band elastic band-assisted PRT focused on enhancing upper limb muscle groups such as pectoralis major, latissimus dorsi, deltoids, biceps brachii, as well as lower limb muscle groups like lateral thigh, quadriceps femoris, and hip muscle groups, effectively reducing the blood lipid level of patients, improving their muscle strength and endurance, and promoting the rehabilitation of patients with ankle instability [30], which supports our research results.

Finally, the absence of statistical inter-group difference in safety showed that Thera-Band elastic band-assisted PRT is a safe exercise intervention method, which is mainly due to the fact that the core of Thera-Band elastic band-assisted PRT is to carry out progressive intensive training according to the patient’s physical state, greatly avoiding related injuries due to excessive exercise intensity.

Several limitations of this study warrant consideration. First, the relatively short follow-up period (12 weeks) precludes assessment of the long-term sustainability of the observed benefits of Thera-Band PRT on physical health and frailty in this population. Second, the single-center nature and modest sample size (n = 48 per group) may limit the generalizability of our findings and increase the risk of type II errors. Finally, the absence of a standardized, universally accepted protocol for Thera-Band PRT means our specific regimen may require further optimization. Future prospective, randomized controlled trials with larger multi-center samples and longer follow-up durations are needed to confirm our findings and establish causality. Of course, we could also establish dose-response studies of optimal Thera-Band resistance levels in frail subgroups, Or standardized PRT protocols incorporating frailty-specific safety algorithms (e.g., modified FITT-VP framework) Of course, cost-effectiveness analyses comparing PRT and pharmaceutical interventions are needed.

Conclusion

Thera-Band elastic band-assisted PRT can significantly improve the health of patients with DM complicated by FS, alleviate frailty, and provide more reliable support for their rehabilitation, with extremely high clinical application value.

Clinical implications of this study

1. Thera-Band elastic band-assisted PRT can more significantly reduce blood glucose levels in patients with DM combined with FS.

2. Thera-Band elastic band-assisted PRT can improve the physical health status of patients with DM combined with FS.

3. Thera-Band elastic band-assisted PRT is safe for the treatment of DM with FS.

4. Thera-Band elastic band-assisted PRT can improve the negative psychology of DM combined with FS.

Key points

To validate the effect of Thera-Band elastic band-assisted PRT in patients with DM combined with FS and to confirm the value of the application of this rehabilitation training protocol.

Author contributions

Min Ye and Lei Zhang made substantial contributions to the concept and design of the study. Qinya Zhu and Huiping Yang were responsible for conducting the data analysis. Min Ye and Xuejiao Cai contributed to the writing and editing of the manuscript. All authors read and approved the final manuscript. All authors have participated sufficiently in the work and agreed to be accountable for all aspects of the work.

Funding

No funding was received.

Data availability

The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

Declarations

Ethics approval and consent to participate

This study was approved by the ethics committee of Zhejiang Rongjun Hospital (2023-(8)). Informed consent was obtained from all individuals included in the study. We ensured that this study complied with the relevant guidelines and ethical principles, including the Declaration of Helsinki and CONSORT guidelines.

Consent for publication

The participants gave written informed consent for their personal or clinical details along with any identifying images to be published in this study.

Competing interests

The authors declare no competing interests.