ABSTRACT
Aims
To investigate the effect of Tai Chi Chuan on balance function in adults 60 years or older with type 2 diabetes and mild cognitive impairment (MCI) in China.
Materials and Methods
This was a three‐arm, parallel‐group, randomized controlled trial with concealed allocation, assessor blinding, intention‐to‐treat (ITT), and per‐protocol (PP) analysis. 328 adults 60 years or older, with a diagnosis of both type 2 diabetes and MCI, were randomly allocated into Tai Chi Chuan group, fitness walking group, and control group. All three groups were provided with a 30‐min diabetes self‐management education session, once every 4 weeks, for 24 weeks. In addition, the Tai Chi Chuan group received 24‐form simplified Tai Chi Chuan. The fitness walking group received fitness walking training. Both Tai Chi Chuan and fitness walking groups took the training for 60 min/session, three times/week, for 24 weeks in a supervised setting. After completing the 24‐week interventions, the participants were encouraged to continue exercise until the 36‐week follow‐up evaluation. The outcomes were time up and go (TUG) assessments, one leg standing test (OLST), functional reach test (FRT), grip strength, 5 time sit to stand test (5STS), modified fall efficacy scale (MFES), and falls data at baseline, 24 weeks, and 36 weeks follow‐up.
Results
At 36 weeks, the Tai Chi Chuan group was significantly more effective in decreasing the TUG‐cognitive‐motor (mean difference, −0.72; 95% CI −1.37 to −0.06), OLST (eyes‐closed, right leg) (mean difference, 1.02; 95% CI 0.24–1.80), FRT (mean difference, 2.00; 95% CI 0.57–3.42), 5STS (mean difference, −0.66; 95% CI −1.28 to −0.04), and MFES (mean difference, 0.36; 95% CI 0.15–0.56) compared with the fitness walking group. The Tai Chi Chuan group showed significantly fewer total falls during 36‐week experimental period compared with the fitness walking group. PP analysis demonstrated similar results as the ITT analysis.
Conclusions
Among the older adults with type 2 diabetes and MCI, Tai Chi Chuan was more effective than fitness walking and control at improving balance function and reducing fall risk.
Keywords: Mild cognitive impairment, Tai Chi Chuan, Type 2 diabetes mellitus
Both type 2 diabetes and mild cognitive impairment (MCI) are associated with balance dysfunction. Physical activity benefits balance function, but no evidence from randomized clinical trials has demonstrated whether Tai Chi Chuan was superior to fitness walking in balance function for older adults with type 2 diabetes and MCI. Therefore, we designed a multi‐center, randomized, parallel controlled clinical trial to explore the effect of Tai Chi Chuan in improving balance function of type 2 diabetes mellitus elders with MCI. The result of our study demonstrated that, at 36 weeks, the Tai Chi Chuan group was significantly more effective in decreasing the TUG‐cognitive‐motor (mean difference, −0.72; 95% CI −1.37 to −0.06), OLST (eyes‐closed, right leg) (mean difference, 1.02; 95% CI 0.24–1.80), FRT (mean difference, 2.00; 95% CI 0.57–3.42), 5STS (mean difference, −0.66; 95% CI −1.28 to −0.04), and MFES (mean difference, 0.36; 95% CI 0.15–0.56) compared with the fitness walking group. The Tai Chi Chuan group showed significantly fewer total falls during 36‐week experiment period compared with the fitness walking group. PP analysis demonstrated similar results as the ITT analysis. Our study concluded that Tai Chi Chuan was better than fitness walking in improving balance function for type 2 diabetes mellitus elders with MCI.
INTRODUCTION
The global diabetes prevalence was estimated to be 10.5% (536.6 million people) in 2021, raising to 12.2% (783.2 million people) by 2045 1 . As a major health issue, type 2 diabetes is the most common type of diabetes, accounting for over 90% of all diabetes worldwide 1 . Mild cognitive impairment (MCI) was a common comorbidity or complication of type 2 diabetes; the prevalence of MCI among type 2 diabetes individuals was reported to be as high as 45% 2 . Balance dysfunction was found in both type 2 diabetes and MCI older adults, which was associated with an increased risk of falling 3 , 4 , 5 . Falls were the leading cause of fatal injuries and the most common cause of non‐fatal injuries related hospitalization in elderly people 6 , 7 . The direct medical costs totaled $637.5 million for fatal and $31.3 billion for non‐fatal fall injury among older American adults in 2015 8 . Therefore, it is particularly important to improve balance function and decrease fall incidence for older adults with type 2 diabetes and MCI.
Recently published meta‐analysis demonstrated that exercise interventions could improve balance function of patients with type 2 diabetes or MCI alone 9 , 10 . However, it is challenging to identify optimal exercise description from available evidence‐based balance function improving interventions since few comparative effectiveness trials were conducted, especially for older adults with type 2 diabetes mellitus and MCI. With the continuing growth and progression of type 2 diabetes and MCI, seeking safe, effective, and easily implementable exercise interventions is of great assistance for clinicians and healthcare organizations. Evidence supported the benefit of Tai Chi Chuan to improve balance function in patients with type 2 diabetes 11 . A consensus statement from the American College of Sports Medicine recommended that Tai Chi Chuan may increase balance and quality of life in adults with type 2 diabetes 12 . Tai Chi Chuan as a mind–body exercise, aims at integrating musculoskeletal, sensory, and cognitive systems. Tai Chi Chuan may benefit more than conventional physical activity for balance function since balance performance is a result of comprehensive interaction between peripheral and central systems. However, no large‐scale randomized clinical trial was conducted to explore the effectiveness of Tai Chi Chuan for balance function among older adults with type 2 diabetes and MCI. To date, no randomized clinical trial has directly compared Tai Chi Chuan with other exercise modalities for balance function in older adults with both type 2 diabetes and MCI.
This secondary analysis of a randomized clinical trial was designed to respond to the evidence gap and clinical decision needs. We aimed to determine the comparative effectiveness of Tai Chi Chuan relative to the fitness walking group and control group (health education) in balance function among older adults with type 2 diabetes and MCI. Our hypothesis was that Tai Chi Chuan would be more effective in improving balance function among older adults with type 2 diabetes and MCI, compared with the fitness walking group and control group.
METHODS
Equity, diversity and inclusion statement
The project group consists of nine women and seven men from four different cities in China with different background disciplines including physiotherapy, nursing, medical doctors, sports and health, and biostatistics. The primary trial report has been published, and additional substudies are planned.
This study included the elderly diagnosed with type 2 diabetes and mild cognitive impairment. These participants were from local communities of four different cities in China, which increases the diversity and generalizability of the results. Data collection was similar for all participants, and we did not modify methods based on regional, educational, or socioeconomic differences. Our analyses do not explore the effects of sex, gender, race/ethnicity, or socioeconomic status since it was not within the scope of this study.
Study design
This is a secondary analysis of a multi‐center randomized clinical trial (clinicalreials.gov ID: NCT04416841) according to the consolidated standards of reporting trials (CONSORT) with three parallel groups. The original study aimed to explore the effectiveness of Tai Chi Chuan on the cognitive function among the older adults with type 2 diabetes and MCI. Related detailed description of this study could be found elsewhere 13 . This study was conducted at four cities in China (Fuzhou; Harbin; Shenzhen; and Beijing). The participant recruitments were started in June 2020, and the follow‐up evaluation ended in February 2022. Written informed consent was required on a voluntary basis at the beginning of the study. This research followed the principles of the Declaration of Helsinki. Ethics approval for the experimental protocol was approved by the local ethics committees at each study site.
Participants
This study was conducted at four research sites in China. Posters and leaflets with research introduction and the inclusion criteria of this study were distributed to the community‐dwelling adults. Inclusion criteria were: (1) clinician diagnosis of type 2 diabetes mellitus; (2) presence of MCI, not demented; (3) age ≥60 years; (4) did not engage in regular exercise in the last 3 months; (5) informed consent and voluntary participation. Exclusion criteria included (1) cognitive impairment caused by other reasons; (2) presence of medical conditions that were unable or unsafe to exercise; (3) participating in other experiments that influenced this study.
Randomization and masking
Eligible community‐dwelling adults were randomly assigned to three groups (Tai Chi Chuan group, fitness walking group, and control group) in a 1:1:1 ratio. A computer‐generated randomization sequence with a block size of 6 was prepared by an independent researcher who was not involved in this research. The randomization sequence was kept in sealed envelopes. Because this study was exercise intervention research, it is impossible to blind participants to intervention allocation. Outcome assessors and data analysts were masked for the group assignments. This study was unblinded after the statistical analyses were completed.
Interventions
All the three groups participants involved a 30‐min health education lecture once per 4 weeks for 24 weeks. These lectures on topics related to diabetes, including proper diets, blood glucose monitoring, and complication prevention, were given by a clinical endocrinologist. For the control group, participants maintained their usual care and previous lifestyle, without receiving any physical activity guidance. For the fitness walking group, participants engaged in 60‐min fitness walking sessions at 50–60% HRmax, three times per week for 24 weeks, under supervision in a flat and open environment. The focus of the fitness walking group was on enhancing aerobic conditioning and gait endurance. For the Tai Chi Chuan group, participants underwent 60‐min sessions three times per week for 24 weeks, which involved practicing the 24‐form Yang‐style Tai Chi under the guidance of certified instructors. The Tai Chi Chuan group placed a particular emphasis on postural control, cognitive sequencing, and dual‐task motor‐cognitive engagement. Both Tai Chi Chuan and fitness walking interventions were led by certified instructors with at least 5 years of experience directing their respective interventions. After completing the 24‐week interventions, the participants were encouraged to continue exercise until the 36‐week follow‐up evaluation. Attendance was systematically recorded at each session for all three groups. Participants were contacted after any missed session and were strongly encouraged to complete as many sessions as possible to ensure maximum benefit from the intervention and to maintain the integrity of the study design.
Measurements and outcomes
All participants were assessed at baseline and at 24 weeks (completion of the inventions), and 36 weeks (12 weeks post‐intervention). Assessments were conducted in accordance with a uniform implementation plan and standard operating procedures.
TUG (time up and go) assessments: Four TUG assessment experimental conditions were implemented. Firstly, the TUG assessment 14 is that participants stand from a chair, walk a distance of 3 m, turn around, and return to the seating position in the chair at the participants' usual walking speed. Secondly, participants were required to complete the TUG assessment while performing a secondary cognitive task of naming different animals as more (TUG‐cognitive). Thirdly, participants were required to complete the TUG assessment while performing a secondary motor task of dominant hand carrying a glass filled with water up to 1 cm from the top edge and no spilling (TUG‐motor). Finally, participants were required to complete the TUG assessment while carrying a glass of water and naming different animals (TUG‐cognitive‐motor). The test completion time was recorded with a stopwatch to an accuracy of 0.01 s. Lower scores (in seconds) indicated better balance.
OLST (one leg standing test, OLST) under both eyes‐open and eyes‐closed conditions by both legs, the participants were requested to stand on one leg with arms on the waist. The time was recorded from the moment of foot off until it touched the floor again. Higher scores (in seconds) indicated better balance.
FRT (functional reach test, FRT), the participants were asked to stand next to a wall and reach forward as far as possible without moving their feet; the maximal distance participants could reach forward beyond the length of their own arms was recorded. Higher scores (in centimeters) indicated better balance.
Grip strength was assessed in both hands using a digital hand dynamometer.
5STS (5 times Sit To Stand, 5STS), the participants were instructed to complete five times full standing from a seated position and return to a seated position as quickly as possible with upper limbs crossed on the chest. The test completion time was recorded with a stopwatch to an accuracy of 0.01 s.
MFES (Modified Falls Efficacy Scale, MFES) is used to measure the capacity of older adults to complete 14 assigned activities without loss of balance confidence. Each item is graded from 0 (no confidence) to 10 (full confidence) points. Calculating the average score of 14 assigned activities, higher scores indicate better fall efficacy.
Fall events: Participants and their families were asked to use a daily “fall calendar” diary to record all fall events.
The TUG‐cognitive‐motor test was selected as the primary outcome due to its ability to assess dual‐task balance performance, which we hypothesized would be particularly responsive to Tai Chi Chuan's integrative motor‐cognitive elements. Other outcomes, such as the OLST, FRT, grip strength, 5STS, and MFES, were included to evaluate static/dynamic balance, functional muscle strength, and balance confidence.
Statistical analysis
Although a difference was anticipated to favor the Tai Chi Chuan group, power was not calculated between Tai Chi Chuan and two other groups owing to the lack of a prior effect size estimates. Assuming an effect size of 0.3, a power of 0.9, an α of 0.05, and with an estimated 20% attrition, the sample size of 60 per group was calculated. Meanwhile, this study was secondary outcome analysis of the trial “Cognitive Effect of Tai Chi Chuan in Adults With Type 2 Diabetes and MCI” 13 which was powered on the primary outcome of MoCA. A sample size was calculated as 109 participants per group based on the primary outcome. Therefore, 109 participants per group were finally determined to ensure sufficient power in this study.
All participants were included in both ITT (intention‐to‐treat) and PP (per‐protocol) analyses. Multiple imputation methods for missing data at baseline, post‐intervention, and at follow‐up assumed that missing data are missing at random. Continuous variables were reported as mean (SD) or median (IQR); one‐way analysis of variance or the Kruskal–Wallis test was used to compare between‐group differences. Categorical variables were described using numbers and percentages and analyzed using the χ2 test or the Fisher exact test. Least Significant Difference adjustments were used for multiple comparisons. Negative binomial regression models were used to estimate between‐group differences in the number of falls. Two‐sided P values of less than 0.05 were considered statistically significant. All statistical analyses were performed using SPSS, version 24.0 (IBM Corporation).
RESULTS
Participants
328 participants (mean [SD] age, 67.55 [5.02] years; type 2 diabetes duration, 10.48 [6.81] years; 50.9% women; all Chinese) were randomized to the Tai Chi Chuan group (n = 107), fitness walking group (n = 110), and control group (n = 111). Participant recruitment started on June 1, 2020, and the last participant completed the follow‐up evaluation on February 28, 2022. From the 906 participants screened for eligibility, 328 were enrolled and randomized in the trial. Among these 328 participants, 303 (92.4%) completed evaluations at 12 weeks, 289 (88.1%) completed evaluations at 24 weeks, and 282 (86.0%) completed evaluations at 36 weeks (Figure 1). All the participants were included in the ITT analysis, and those who attended evaluations at 36 weeks were included in the per‐protocol analysis. The baseline demographic and clinical characteristics of participants are summarized in Table 1. Table 1 presents the baseline demographic and clinical characteristics of participants across the three groups. The three groups were comparable in age, sex, BMI, disease duration, education duration, comorbid illness, smoking and drinking status, blood pressure, and diabetes medications at baseline. Median number of diabetes medications, patient self‐reported dietary calorie intake, and physical activity of the three groups by ITT are shown in Table S1.
Figure 1.
Study flowchart.
Table 1.
Baseline characteristics of participants
| Variable | Tai Chi Chuan | Fitness walking | Control |
|---|---|---|---|
| No. | 107 | 110 | 111 |
| Age, mean (SD), year | 67.56 (4.99) | 67.46 (4.73) | 67.62 (5.35) |
| Sex, no. (%) | |||
| Female | 58 (54.2) | 49 (44.5) | 60 (54.1) |
| Male | 49 (45.8) | 61 (55.5) | 51 (45.9) |
| BMI (kg/m2) | 24.32 (3.03) | 23.86 (2.9) | 23.98 (3.4) |
| Disease duration, mean (SD), year | 9.82 (5.58) | 10.70 (7.49) | 10.90 (7.2) |
| Education duration, mean (SD), year | 10.36 (3.27) | 9.92 (3.59) | 10.13 (3.47) |
| Comorbid illness, no. (%) † | |||
| ≤1 | 85 (79.4) | 86 (78.2) | 84 (75.7) |
| >1 | 22 (20.6) | 24 (21.8) | 27 (24.3) |
| Smoking, no. (%) | |||
| Never | 79 (73.8) | 71 (64.5) | 87 (78.4) |
| Former | 21 (19.6) | 25 (22.7) | 18 (16.2) |
| Current | 7 (6.5) | 14 (12.7) | 6 (5.4) |
| Drinking, no. (%) | |||
| Never | 75 (70.1) | 79 (71.8) | 83 (74.8) |
| Former | 18 (16.8) | 8 (7.3) | 13 (11.7) |
| Current | 14 (13.1) | 23 (20.9) | 15 (13.5) |
| Blood pressure, mean (SD), mmHg | |||
| Systolic | 130.59 (13.82) | 130.52 (13.22) | 131.46 (12.84) |
| Diastolic | 79.27 (10.31) | 80.17 (9.99) | 78.71 (9.13) |
| Fasting glucose (mmol/L) | 7.53 (2.35) | 7.49 (2.22) | 7.91 (2.33) |
| HbA1c, % | 7.04 (1.2) | 6.84 (1.41) | 7.14 (1.48) |
| Diabetes medications, no. (%) | |||
| Metformin | 61 (57) | 55 (50) | 61 (55) |
| Sulfonylurea | 20 (18.7) | 26 (23.6) | 22 (19.8) |
| Glinides | 12 (11.2) | 5 (4.5) | 5 (4.5) |
| α‐glucosidase inhibitor | 33 (30.8) | 24 (21.8) | 34 (30.6) |
| DPP‐4 inhibitor | 15 (14) | 9 (8.2) | 9 (8.1) |
| Insulin dose | 18 (16.8) | 25 (22.7) | 20 (18) |
Comorbidities were reported at screening. Selected comorbidities are presented based on a history of any of the following: hypertension, coronary artery disease, chronic obstructive pulmonary disease, and dyslipidemia.
The overall intervention attendance rate across the 24 weeks was 95 (88.8%) in the Tai Chi Chuan group and 99 (90.0%) in the fitness walking group (i.e., attended at least 54 sessions, or >75.0% of the planned total intervention class sessions). The mean (SD) number of completed sessions was 63 (5) for the Tai Chi Chuan and fitness walking groups, 64 (5) in the Tai Chi Chuan group, and 63 (5) in the fitness walking group, with no significant difference between groups (P = 0.08).
Table 2 displays between‐group mean differences in all four TUG conditions at 24 and 36 weeks by ITT analysis, highlighting the superior effects of Tai Chi Chuan on TUG‐cognitive‐motor performance compared with the fitness walking group. Table 3 summarizes differences in OLST, FRT, 5STS, grip strength, and MFES scores at 24 and 36 weeks by ITT analysis, demonstrating significant improvements in balance, lower limb function, and balance confidence in the Tai Chi group compared with the fitness walking group. PP analysis demonstrated similar results as the ITT analysis (Tables S2 and S3). The detailed between‐group comparisons of each outcome were as follows:
Table 2.
Mean difference in TUG assessments in three groups by ITT analyses
| ITT analysis | Study group | Between‐group change, mean (95% CI) | |||||
|---|---|---|---|---|---|---|---|
| Tai Chi Chuan (n = 107) | Fitness walking (n = 110) | Control (n = 111) | P value | Tai Chi Chuan vs fitness walking | Tai Chi Chuan vs control | Fitness walking vs control | |
| TUG, mean (SD), s † | |||||||
| Baseline | 10.92 (2.52) | 10.71 (2.06) | 11.00 (2.24) | 0.618 | 0.21 (−0.40, 0.82) | −0.08 (−0.69, 0.52) | −0.29 (−0.90, 0.31) |
| 24 week | 9.99 (1.60) | 10.08 (1.51) | 10.45 (1.96) | 0.104 | −0.09 (−0.55, 0.36) | −0.46 (−0.92, −0.01)* | −0.37 (−0.82, 0.08) |
| 36 week | 10.11 (1.78) | 10.04 (1.59) | 10.36 (1.93) | 0.368 | 0.07 (−0.40, 0.54) | −0.25 (−0.72, 0.22) | −0.32 (−0.79, 0.15) |
| TUG‐cognitive, mean (SD), s † | |||||||
| Baseline | 13.17 (3.19) | 12.72 (2.78) | 13.10 (2.82) | 0.481 | 0.45 (−0.34, 1.23) | 0.07 (−0.72, 0.85) | −0.38 (−1.16, 0.40) |
| 24 week | 11.84 (2.34) | 11.64 (2.26) | 12.48 (2.62) | 0.026 | 0.21 (−0.44, 0.85) | −0.64 (−1.28, 0.00) | −0.85 (−1.49, −0.21)* |
| 36 week | 11.82 (1.94) | 11.68 (2.24) | 12.27 (2.77) | 0.146 | 0.14 (−0.49, 0.77) | −0.45 (−1.08, 0.17) | −0.59 (−1.22, 0.03) |
| TUG‐motor, mean (SD), s † | |||||||
| Baseline | 11.95 (2.86) | 11.57 (2.26) | 11.99 (2.32) | 0.375 | 0.39 (−0.28, 1.05) | −0.04 (−0.70, 0.62) | −0.43 (−1.09, 0.23) |
| 24 week | 10.60 (1.68) | 10.68 (1.71) | 11.20 (2.17) | 0.037 | −0.08 (−0.58, 0.42) | −0.60 (−1.10, −0.10)* | −0.52 (−1.01, −0.02)* |
| 36 week | 10.85 (1.78) | 10.80 (1.75) | 11.08 (2.24) | 0.53 | 0.06 (−0.46, 0.57) | −0.22 (−0.74, 0.29) | −0.28 (−0.79, 0.23) |
| TUG‐cognitive‐motor, mean (SD), s † | |||||||
| Baseline | 14.03 (3.18) | 13.83 (2.96) | 14.11 (3.05) | 0.781 | 0.20 (−0.62, 1.02) | −0.08 (−0.90, 0.74) | −0.28 (−1.09, 0.53) |
| 24 week | 12.26 (2.63) | 12.40 (2.31) | 13.37 (3.22) | 0.005 | −0.15 (−0.88, 0.59) | −1.12 (−1.85, −0.38)* | −0.97 (−1.70, −0.24)* |
| 36 week | 11.88 (1.74) | 12.60 (2.60) | 13.40 (2.85) | <0.001 | −0.72 (−1.37, −0.06)* | −1.52 (−2.17, −0.87)* | −0.80 (−1.45, −0.15)* |
P < 0.05.
Lower score indicating better balance function.
ITT, intention to treat; PP, per‐protocol; TUG, time up and go.
Table 3.
Mean difference in other outcomes in three groups by ITT analyses
| ITT analysis | Study group | Between‐group change, mean (95% CI) | |||||
|---|---|---|---|---|---|---|---|
| Tai Chi Chuan (n = 107) | Fitness walking (n = 110) | Control (n = 111) | P value | Tai Chi Chuan vs fitness walking | Tai Chi Chuan vs control | Fitness walking vs control | |
| OLST (eyes‐open, left leg), median (IQR), s † | |||||||
| Baseline | 8.94 (15.24) | 11.80 (16.16) | 10.58 (15.45) | 0.236 | −1.24 (−5.44, 2.96) | 0.81 (−3.38, 5.00) | 2.05 (−2.11, 6.21) |
| 24 week | 14.56 (21.47) | 14.77 (23.85) | 15.06 (18.48) | 0.666 | −1.60 (−6.18, 2.97) | 1.90 (−2.66, 6.47) | 3.50 (−1.03, 8.04) |
| 36 week | 15.00 (23.20) | 15.10 (24.46) | 13.17 (17.74) | 0.361 | 0.00 (−4.53, 4.54) | 3.19 (−1.33, 7.71) | 3.19 (−1.31, 7.68) |
| OLST (eyes‐open, right leg), median (IQR), s † | |||||||
| Baseline | 9.72 (15.98) | 13.58 (17.90) | 12.11 (21.07) | 0.131 | −4.16 (−8.52, 0.21) | −2.69 (−7.05, 1.66) | 1.47 (−2.86, 5.79) |
| 24 week | 14.48 (21.65) | 19.67 (25.25) | 18.92 (21.85) | 0.66 | −2.92 (−7.77, 1.93) | −0.26 (−5.10, 4.58) | 2.66 (−2.14, 7.47) |
| 36 week | 16.00 (21.98) | 15.80 (20.62) | 17.00 (20.66) | 0.813 | 0.26 (−4.18, 4.71) | 2.83 (−1.61, 7.26) | 2.56 (−1.84, 6.97) |
| OLST (eyes‐closed, left leg), median (IQR), s † | |||||||
| Baseline | 3.39 (2.01) | 3.27 (2.72) | 3.10 (2.94) | 0.41 | −0.45 (−1.17, 0.27) | −0.20 (−0.92, 0.52) | 0.26 (−0.46, 0.97) |
| 24 week | 3.98 (2.63) | 3.77 (3.58) | 3.56 (3.33) | 0.208 | 0.02 (−0.78, 0.82) | 0.38 (−0.41, 1.18) | 0.37 (−0.43, 1.16) |
| 36 week | 4.11 (2.44) | 3.67 (3.03) | 3.45 (2.73) | 0.039 | 0.29 (−0.42, 1.01) | 0.41 (−0.31, 1.12) | 0.11 (−0.60, 0.82) |
| OLST (eyes‐closed, right leg), median (IQR), s † | |||||||
| Baseline | 3.75 (2.80) | 3.83 (3.03) | 3.40 (4.55) | 0.72 | 0.05 (−0.79, 0.89) | −0.61 (−1.45, 0.23) | −0.66 (−1.49, 0.17) |
| 24 week | 4.26 (2.89) | 4.05 (3.14) | 3.83 (3.78) | 0.414 | 0.14 (−0.71, 0.99) | 0.01 (−0.84, 0.86) | −0.13 (−0.97, 0.71) |
| 36 week | 4.73 (3.34) | 3.49 (2.96) | 3.53 (2.79) | <0.001 | 1.02 (0.24, 1.80)* | 1.06 (0.28, 1.84)* | 0.04 (−0.74, 0.82) |
| FRT, mean (SD), cm ‡ | |||||||
| Baseline | 32.77 (6.16) | 32.44 (5.71) | 31.63 (6.47) | 0.37 | 0.34 (−1.30, 1.97) | 1.14 (−0.50, 2.77) | 0.80 (−0.82, 2.42) |
| 24 week | 34.58 (4.78) | 34.33 (4.97) | 32.84 (4.84) | 0.018 | 0.24 (−1.06, 1.54) | 1.73 (0.44, 3.03)* | 1.49 (0.20, 2.78)* |
| 36 week | 34.40 (5.21) | 33.85 (5.62) | 32.40 (5.19) | 0.018 | 0.55 (−0.88, 1.98) | 2.00 (0.57, 3.42)* | 1.44 (0.03, 2.86)* |
| Grip strength (left), mean (SD), kg § | |||||||
| Baseline | 25.62 (8.40) | 26.75 (8.94) | 25.36 (8.47) | 0.446 | −1.13 (−3.43, 1.17) | 0.26 (−2.03, 2.56) | 1.39 (−0.89, 3.67) |
| 24 week | 25.16 (7.77) | 26.62 (8.77) | 25.44 (7.25) | 0.356 | −1.46 (−3.58, 0.66) | −0.28 (−2.40, 1.83) | 1.18 (−0.93, 3.28) |
| 36 week | 25.08 (7.57) | 27.00 (8.48) | 25.75 (7.56) | 0.19 | −1.92 (−4.03, 0.18) | −0.67 (−2.77, 1.43) | 1.25 (−0.83, 3.34) |
| Grip strength (right), mean (SD), kg § | |||||||
| Baseline | 28.26 (8.16) | 29.27 (9.67) | 27.35 (9.57) | 0.301 | −1.00 (−3.45, 1.45) | 0.91 (−1.53, 3.36) | 1.92 (−0.51, 4.34) |
| 24 week | 27.96 (8.17) | 29.26 (9.21) | 28.02 (7.93) | 0.439 | −1.30 (−3.56, 0.96) | −0.06 (−2.31, 2.19) | 1.24 (−1.00, 3.48) |
| 36 week | 28.11 (8.03) | 29.57 (9.25) | 27.84 (7.79) | 0.261 | −1.46 (−3.70, 0.78) | 0.27 (−1.96, 2.50) | 1.73 (−0.49, 3.94) |
| 5STS, mean (SD), s ¶ | |||||||
| Baseline | 12.22 (2.88) | 11.85 (2.48) | 12.28 (2.42) | 0.405 | 0.37 (−0.32, 1.06) | −0.07 (−0.76, 0.62) | −0.44 (−1.13, 0.25) |
| 24 week | 11.06 (2.60) | 11.09 (2.03) | 12.09 (1.92) | 0.001 | −0.03 (−0.62, 0.56) | −1.03 (−1.61, −0.44)* | −0.99 (−1.58, −0.41)* |
| 36 week | 10.45 (2.11) | 11.11 (2.36) | 11.76 (2.48) | <0.001 | −0.66 (−1.28, −0.04)* | −1.31 (−1.93, −0.69)* | −0.65 (−1.26, −0.03)* |
| MFES average scores, mean (SD) †† | |||||||
| Baseline | 8.60 (1.13) | 8.75 (1.13) | 8.63 (1.13) | 0.589 | −0.15 (−0.45, 0.15) | −0.03 (−0.33, 0.27) | 0.12 (−0.18, 0.42) |
| 24 week | 9.22 (0.51) | 8.86 (0.88) | 8.87 (0.87) | 0.001 | 0.36 (0.15, 0.56)* | 0.35 (0.14, 0.55)* | −0.01 (−0.21, 0.20) |
| 36 week | 9.34 (0.65) | 8.97 (0.95) | 9.01 (0.88) | 0.002 | 0.37 (0.15, 0.60)* | 0.34 (0.11, 0.56)* | −0.03 (−0.26, 0.19) |
P < 0.05.
Scores range from 0 to 60, with higher scores indicating better balance function.
Higher scores indicating better balance function.
Higher scores indicating better grip strength.
Lower scores indicating better balance function.
Scores ranging from 0 to 10, with higher scores indicating better balance confidence.
5STS, five times sit to stand; FRT, functional reach test; ITT, intention to treat; MFES, modified fall efficacy scale; OLST, one leg standing test.
TUG assessments: In the ITT analysis, at 24 weeks, the Tai Chi Chuan group was significantly more effective in decreasing the TUG (mean difference, −0.46; 95% CI −0.92 to −0.01), TUG‐motor (mean difference, −0.60; 95% CI −1.10 to −0.10), and TUG‐cognitive‐motor (mean difference, −1.12; 95% CI −1.85 to −0.38) compared with the control group. The fitness walking group was significantly more effective in decreasing the TUG‐cognitive (mean difference, −0.85; 95% CI −1.49 to −0.21), TUG‐motor (mean difference, −0.52; 95% CI −1.01 to −0.02), and TUG‐cognitive‐motor (mean difference, −0.97; 95% CI −1.70 to −0.24). At 36 weeks, the Tai Chi Chuan group was significantly more effective in decreasing the TUG‐cognitive‐motor compared with the fitness walking group (mean difference, −0.72; 95% CI −1.37 to −0.06) and control group (mean difference, −1.52; 95% CI −2.17 to −0.87). The fitness walking group was significantly more effective in decreasing the TUG‐cognitive‐motor compared with the control group (mean difference, −0.8; 95% CI −1.45 to −0.15) (Table 2). PP analysis demonstrated similar results as the ITT analysis (Table S2).
OLST: In the ITT analysis, at 24 weeks, there were no significant differences in all OLST among the three groups. At 36 weeks, the Tai Chi Chuan group was significantly more effective in improving the OLST (eyes‐closed, right leg) compared with the fitness walking group (mean difference, 1.02; 95% CI 0.24–1.80) and the control group (mean difference, 1.06; 95% CI 0.28–1.84) (Table 3). PP analysis demonstrated similar results as the ITT analysis (Table S3).
FRT: In the ITT analysis, at 24 weeks, the Tai Chi Chuan group (mean difference, 1.73; 95% CI 0.44–3.03) and fitness walking group (mean difference, 1.49; 95% CI 0.20–2.78) were significantly more effective in improving FRT compared with the control group. At 36 weeks, the Tai Chi Chuan group (mean difference, 2.00; 95% CI 0.57–3.42) and fitness walking group (mean difference, 1.44; 95% CI 0.03–2.86) were significantly more effective in improving FRT compared with the control group. There were no significant differences in FRT between the Tai Chi Chuan group and the fitness walking group at both 24 and 36 weeks (Table 3). PP analysis demonstrated similar results as the ITT analysis (Table S3).
Grip strength: There were no significant differences in grip strength among three groups at both 24 and 36 weeks in ITT and PP analysis (Table 3, Table S3).
5STS: In the ITT analysis, at 24 weeks, the Tai Chi Chuan group (mean difference, −1.03; 95% CI −1.61 to −0.44) and fitness walking group (mean difference, −0.99; 95% CI −1.58 to −0.41) were significantly more effective in decreasing the 5STS compared with the control group. At 36 weeks, the Tai Chi Chuan group was significantly more effective in decreasing the 5STS compared with the fitness walking group (mean difference, −0.66; 95% CI −1.28 to −0.04) and control group (mean difference, −1.31; 95% CI −1.93 to −0.69). The fitness walking group was significantly more effective in decreasing the 5STS compared with the control group (mean difference, −0.65; 95% CI −1.26 to −0.03). PP analysis demonstrated similar results as the ITT analysis.
MFES: In the ITT analysis, at 24 weeks, the Tai Chi Chuan group was significantly more effective in improving the MFES average scores compared with the fitness walking group (mean difference, 0.36; 95% CI 0.15–0.56) and control group (mean difference, 0.34; 95% CI 0.14–0.55). At 36 weeks, the Tai Chi Chuan group was significantly more effective in improving the MFES average scores compared with the fitness walking group (mean difference, 0.37; 95% CI 0.15–0.60) and control group (mean difference, 0.34; 95% CI 0.11–0.56) (Table 3). PP analysis demonstrated similar results as the ITT analysis (Table S3).
Falls events: Tai Chi Chuan group showed significantly fewer total falls during 36 weeks experimental period compared with fitness walking and control group in both ITT and PP analysis (Table S4).
Adverse events: Hypoglycemia events occurred in one participant (0.9%) in the Tai Chi Chuan group and in two participants (1.8%) in the fitness walking group. One participant (0.9%) in the Tai Chi Chuan group and one (0.9%) in the fitness walking group suffered a fracture. One participant (0.9%) reported hospital admission in the control group, and one participant (0.9%) required an emergency department visit in the Tai Chi Chuan group. There was no statistically significant difference for total adverse events among the three groups (P = 0.542) (Table S5).
DISCUSSION
In this secondary analysis study of the older adults with type 2 diabetes and MCI, we found that Tai Chi Chuan was effective in improving TUG‐cognitive‐motor, OLST (eyes‐closed, right leg), and 5STS performance compared with the fitness walking and control groups at 36 weeks. Also, Tai Chi Chuan was effective in improving MFES average scores compared with fitness walking and control groups at 24 weeks. In addition, the Tai Chi Chuan group was effective in reducing the incidence of falls during the 36 weeks trial period compared with the fitness walking and control groups. To our knowledge, this study showed for the first time that Tai Chi Chuan as a mind–body exercise was effective in improving balance function for the older adults with type 2 diabetes and MCI compared with the fitness walking and control groups.
The findings of this study were consistent with previous systematic reviews and meta‐analyses on the effect of Tai Chi Chuan improving balance function, fall efficacy, and reducing fall incidence 15 , 16 , 17 . As an evidence‐based head‐to‐head comparison, meta‐analysis showed that fitness walking could improve health‐related physical fitness and balance function among the elderly 18 . Our study also supported that fitness walking was effective in improving TUG‐cognitive, TUG‐motor, TUG‐cognitive‐motor, FRT, and 5STS compared with the control group. However, this study found that Tai Chi Chuan was superior to fitness walking in terms of TUG‐cognitive‐motor, OLST (eyes‐closed, right leg), and 5STS. A previous study concluded that both Tai Chi Chuan and fitness walking interventions could improve the balance ability of elderly women, and Tai Chi Chuan was more efficient in single‐leg standing performance, which was aligned with this trial 19 .
Tai Chi Chuan is a traditional Chinese mind–body exercise, aiming at integrating musculoskeletal, sensory, and cognitive systems. It focuses on controlled, self‐initiated exercise with synchronized breathing, and the movement patterns include center of gravity displacement, weight bearing and shifting, trunk and pelvic rotation, and eye‐hand coordinated movements. Although the benefit of Tai Chi Chuan in improving balance function has been proven, the mechanisms for Tai Chi Chuan to improve the balance function of older adults with type 2 diabetes and MCI were diverse. Firstly, the continuous transfer of weight from one leg to another during Tai Chi Chuan practice is beneficial for improving dynamic standing balance and lower limb strength 20 . Tai Chi Chuan involves various movements that activate and strengthen the muscles of the legs, hips, and core, which in turn improves the stability of the lower body and trunk by maintaining postural muscles eccentric contraction 21 . This may be the reason why Tai Chi Chuan was more effective in improving 5STS performance compared with the fitness walking and control groups. Secondly, Tai Chi Chuan involves a wide range of motion, which can improve joint flexibility, especially in the hips, knees, and ankles. This increased flexibility enables better control over movements, and the Tai Chi Chuan characteristic of flowing circular and spiral movements could also promote joint flexibility 20 . It might be the reason why Tai Chi Chuan improves the functional reach distance.
Thirdly, the vestibular system in the inner ear is responsible for maintaining balance and spatial orientation. Tai Chi Chuan movements involve a variety of body positions and movements that stimulate the vestibular system, improving gaze control and postural stability, leading to improved balance function 22 , 23 . Tai Chi Chuan was helpful in reorganizing lower extremity neuromuscular patterns, which appear to promote a faster gait and reduce excessive hip compensation 24 . Fourthly, almost all Tai Chi movements are performed in a semi‐squat position, which puts greater pressure on the knee joints and provides a wide range of motion to control the height of the center of gravity during smooth and slow movements. This movement characteristic improves the proprioceptive sensation of the practitioner's knee joint 25 . Importantly, repetitive practice involving diagonal patterns of the trunk and upper and lower limbs may improve coordination and rhythmic muscle contraction between agonists and antagonists. Tai Chi Chuan improves proprioception by requiring the practitioner to maintain proper body alignment and balance during movements 26 . This leads to better awareness of body position and improved ability to make adjustments in response to changes in balance. Thus, Tai Chi Chuan training is characterized by weight shifting and ankle sway, which can improve the ability of older adults to adopt effective swing strategies, such as ankle or hip, and engage in controlled movements at the limit of postural stability to improve balance control 27 . The improvements of OLST in Tai Chi Chuan may be attributed to these factors.
Finally, Tai Chi Chuan requires concentration, attention, and memory, and has been shown to improve cognitive function, including attention and executive function 28 , 29 . Our recently published study demonstrated that Tai Chi Chuan could significantly improve cognitive function for the older adults with type 2 diabetes and MCI 13 . The muscle strengthening components of Tai Chi Chuan induced the release of neurochemicals such as brain derived neurotrophic factor, insulin like growth factor 1, and homocysteine, which had a positive effect on cognitive function 30 . Research has shown that Tai Chi Chuan improved the structure and function of the brain regions which were critical to the regulation of cognitive function 31 . The optimized execution function could coordinate the competition between gait and concomitant cognitive tasks for attention, so as to improve physical stability, and increased cognitive function may improve the ability to anticipate and respond to changes in balance 32 . Besides, higher fall efficacy was associated with enhanced mobility performance 33 . This study reported that Tai Chi Chuan significantly improved fall efficacy at 24 and 36 weeks compared with fitness walking and control groups. Overall, Tai Chi Chuan improves balance function and reduces fall incidence through a combination of improved muscle strength, joint flexibility, enhanced proprioception, increased vestibular stimulation, and increased cognitive and psychological functions. Tai Chi Chuan's choreographed, mindful movements require simultaneous motor planning, attention shifting, and memory retrieval. These multi‐domain demands are likely to activate prefrontal cortex regions associated with executive function, thereby improving dual‐task performance 34 . Prior study showed increased prefrontal activation following Tai Chi in older adults, supporting its dual‐task training potential 34 .
In addition, both brain derived neurotrophic factor and growth factor 1 are critically involved in hippocampal plasticity, synaptic remodeling, and memory consolidation; they may contribute to improvements in executive function and working memory in individuals with MCI and type 2 diabetes 35 . Given the bidirectional relationship between type 2 diabetes and neurodegeneration, interventions that simultaneously address glycemic control, balance, and cognitive function are of great clinical value. The observed cognitive‐motor improvements in the Tai Chi Chuan group suggest potential for Tai Chi Chuan to serve as a non‐pharmacological intervention to delay progression from MCI to dementia. Tai Chi is low‐cost, low‐impact, and adaptable to older adults, making it feasible for widespread community‐based implementation. It offers a promising strategy for reducing dementia risk and maintaining functional independence 36 .
This study has several important strengths. A larger sample size from 4 centers was recruited, which enhanced generalizability and scalability. A high adherence rate existed in our study because of a highly supervised exercise intervention. Strict randomized controlled clinical trial methods were adopted to ensure the quality of this study. Comprehensive balance‐related outcome indicators were assessed by ITT and PP analysis.
Limitations
This study also has limitations. Firstly, given the exercise intervention, participants were aware of their intervention. Interested participants had positive expectations for the benefits of exercise, which may have introduced biases in the results. Secondly, this study only includes the older adults of type 2 diabetes with MCI who meet the inclusion criteria of the study; the patients with serious complications are not included, which will restrict the promotion of the Tai Chi Chuan exercise program. Third, falls data were collected by calendars kept by participants; self‐reporting bias existed since the participants were MCI.
Clinical implications
Balance dysfunction and high fall risk are major global challenges for the elderly. Exercise intervention is an important component of diabetes and cognitive impairment management. Tai Chi Chuan may be more effective than fitness walking in improving balance function and reducing fall risk among the older patients with type 2 diabetes and MCI. More head‐to‐head trials are needed to determine the better effect and dose–response of Tai Chi Chuan for improving balance function among the elderly with type 2 diabetes and MCI. Tele‐assessment is a valid and reliable tool for assessing functional capacity in type 2 diabetes patients, suggesting it can be a viable alternative to traditional center‐based assessments 37 . Tele‐rehabilitation exercise programs are effective in improving glycemic control, functional capacity, muscle strength, and quality of life in patients with type 2 diabetes, supporting the use of telehealth in Tai Chi Chuan practice 38 . Integrating Tai Chi Chuan into such platforms may enhance accessibility and adherence in community‐dwelling populations.
CONCLUSION
In conclusion, among the older adults with type 2 diabetes and MCI, Tai Chi Chuan was more effective than fitness walking and a control condition involving diabetes health education only in improving balance function and reducing fall risk. As a promising low‐cost and easily implemented exercise, its demonstrated generalizability and scalability can help clinicians and public health organizations to adopt Tai Chi Chuan to benefit the older adults with type 2 diabetes and MCI.
FUNDING
This study was supported by a grant from the Key Research and Development project funded by the Ministry of Science and Technology of the People's Republic of China (Grant No. 2019YFC1710301).
DISCLOSURE
The authors declare no conflict of interest.
Approval of the research protocol: This study conformed to the provisions of the Declaration of Helsinki. Ethics approval was obtained from the ethics committees of Second People's Hospital Affiliated to Fujian University of Traditional Chinese Medicine (2020KY‐004‐02), Second People's Hospital Affiliated to Heilongjiang University of Traditional Chinese Medicine (2020‐K24), Xiyuan Hospital of China Academy of Chinese Medical Sciences (2020XLA033‐2), and Shenzhen Bao'an District People's Hospital (BYL20200409).
Informed consent: All participants signed written informed consent before eligibility screening.
Registry and the registration no. of the study/trial: Clinicaltrials.gov: NCT04416841 (Registration Date: May 26, 2020).
Animal studies: N/A.
Supporting information
Table S1 | Medians (IQR) of diabetes medication, patient self‐reported dietary calories and physical activity of three groups by intention‐to‐treat (ITT) analyses.
Table S2 | Mean difference in time up and go (TUG) assessments in three groups by PP analyses.
Table S3 | Mean difference in other outcomes in three groups by per‐protocol (PP) analyses.
Table S4 | Total falls in three groups by intention‐to‐treat (ITT) and per‐protocol (PP) analyses.
Table S5 | Safety outcomes – adverse events.
ACKNOWLEDGMENTS
We would like to thank all the patients for their participation.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Table S1 | Medians (IQR) of diabetes medication, patient self‐reported dietary calories and physical activity of three groups by intention‐to‐treat (ITT) analyses.
Table S2 | Mean difference in time up and go (TUG) assessments in three groups by PP analyses.
Table S3 | Mean difference in other outcomes in three groups by per‐protocol (PP) analyses.
Table S4 | Total falls in three groups by intention‐to‐treat (ITT) and per‐protocol (PP) analyses.
Table S5 | Safety outcomes – adverse events.