Design and setting

A 12-week randomised controlled trial (RCT) will study the effects of Elastic-band Baduanjin exercise and Baduanjin groups on muscle strength, body composition, blood glucose and balance function in older adults with T2DM. The outcomes will be compared between the intervention and control groups. Participants in the intervention group will maintain their original habits, will not undergo other sports training and will practice Elastic-band Baduanjin exercise, while participants in the control group will exercise according to the 2003 General Administration of Sports of China Qigong-Baduanjin recommendations.

The study will be conducted at the Tangzhen Community Health Care Center, where participants will be guided by professional exercise coaches and qualified trained researchers. Study participants will be recruited from the community. According to the health information system, a total of 2278 individuals were registered with a diagnosis of T2DM.

Ethics

The trial was approved by the Chinese Ethics Committee of Registering Clinical Trials on 19 June 2022 (ChiECRCT20220210).

Study participants

Older adults with T2DM at Tangzhen Community Health Care Center were selected for the study.

Eligibility criteria

Inclusion criteria: (a) compliance with the diagnostic criteria for the ‘Guidelines for the prevention and treatment of type 2 diabetes mellitus in China (2020 edition)’ (table 1); (b) age 60–80 years old; (c) patients who are aware and able to communicate and (d) patients who participate voluntarily in this study.

Exclusion criteria: (a) patients diagnosed with underlying severe eye disease; serious cardiac, liver, kidney and lung function impairment; or severe cardiovascular disease, for which exercise is not recommended; (b) patients who have been diagnosed with severe bone, joint or muscle damage and for whom exercise is not recommended; and (c) history of regular exercise within the last 3 months, for example, regular jogging ≥3 times per week.

Withdrawal criteria: (a) patients may voluntarily withdraw during the intervention; (b) patients presenting adverse events or changes that interfere with cooperation with study activities. Adverse events are defined as adverse effects such as hunger, panic, cold sweat, hypoglycaemic symptoms such as dizziness and weakness of limbs, and falls during or after exercise. Once adverse effects occur, a community general practitioner will conduct an assessment and provide a management plan.

The discontinuation criteria were as follows: (a) patients presenting adverse events or extraordinary physiological changes during the intervention and considered unsuitable for further participation; (b) patients with severe complications or changes in their condition during the intervention, who require emergency measures, or who have difficulty cooperating due to changes in the treatment protocol; and (c) patients who voluntarily withdraw during the intervention.

Patient and public involvement

The Elastic-band Baduanjin exercise programme will be formed by on-site observation and qualitative interview methods. To design a user-centred exercise programme by collecting patients’ experiences and feelings. These data will then guide the design of the Elastic-band Baduanjin exercise programme. However, patients will not be involved in the design, or conduct, or reporting, or dissemination plans of this study.

Recruitment

This study will be conducted at the Community Health Centre. A research team consisting of community general practitioners, traditional Gongfu specialists, sports medicine specialists, community nurses and postgraduate students will be responsible for the guidance of the programme, implementation of the intervention, and the collection of baseline and follow-up data. Study staff will undergo rigorous and uniform training before data collection.

Potential study participants among older adults with T2DM currently on a file at a community health centre will be initially screened by telephone. After an initial assessment confirming that the patient had no regular exercise habits and was willing to participate in the study, an appointment will be made for a face-to-face evaluation in the community. During this evaluation, the researcher will provide more information about the programme and eligible patients will complete a baseline evaluation on the same day, including the collection of biochemical indicators and questionnaires. Elastic-band Baduanjin or Baduanjin exercises require correction and guidance from the researcher to ensure that the movements are up to the standard. The researcher will inform patients of the weekly exercise frequency and identify appointments for the next one-to-one exercise sessions (see figure 1).

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Figure 1

Consort flow diagram of the study design.

During exercise training, the researcher will inform the patient of the purpose and content as much as possible without compromising data collection and will obtain written consent from the patient. The researcher must inform the patient of the right to refuse and withdraw from the study before the study starting or during the process, and will share the results with the patient when available.

Random sampling and blinding

The study will use cluster randomisation, the 18 village neighbourhood committees of the Tangzhen Community Health Care Center, as a cluster. Non-research staff will, via Excel Office 2019 software, randomly assign two groups in a ratio of 1:1, with number 1 included in the Baduanjin control group and number 2 included in the Elastic-band Baduanjin exercise intervention group. Blinding is an essential measure for controlling and detecting bias in RCTs, and this study was blind to data analysts. Due to exercise interventions, it was not possible to blind the participants and study researchers. However, the study participants were blinded to the grouping. Moreover, because participants will be grouped by neighbourhood committees, contamination and interference within the same community will be avoided.

Intervention design

The RCT will be divided into an Elastic-band Baduanjin exercise group and a Baduanjin group, and participants in both groups will exercise for 12 weeks. During the first 4 weeks, participants will attend the activity room of the Tangzhen Community Health Care Center once a week for exercise, where members of the research team will explain, instruct and train the participants, observe their tolerance to exercise, and make timely adjustments. During the last 8 weeks, participants will attend the activity room once every 4 weeks. During the remaining time, the participants will complete the exercises required by the home programme of each group. Meanwhile, researchers will receive a video demonstration of the programme and relevant written materials for self-correction during initial training. Researchers will be followed every fortnight to ensure compliance and safety of home exercise.

This study will strictly include participants according to the inclusion criteria, ensuring that the grouping is random and the consistency of the primary data. Before the intervention, the research team will be systematically standardised and trained. The intervention implementers will be proficient in the specific implementation methods of the exercise programme, establish a good trust relationship with the participants and conduct the intervention in strict accordance with the construction plan. In the learning and guidance stage, researchers will uniformly guide professional sports coaches and qualified training members to prevent inconsistencies in exercise and assessment standards.

The statement that the risk of bias in this study includes selection, performance, detection and other potential sources of bias still needs to be fully addressed. T2DM is a chronic disease; the effects of muscle mass and glycaemia cannot be seen in the short term in the elderly. Clinical studies tend to use 12 weeks as the time point for the number of measurements,27 28 and based on cost considerations, this study chose to measure at both baseline and postintervention time points. However, this study needed more monitoring during the follow-up period.

Baduanjin control group

Patients will maintain their original dietary control, blood glucose monitoring, regular medication with oral hypoglycaemic drugs or insulin, and uniform health education. They will carry out Baduanjin exercises according to the 2003 General Administration of Sports of China, without any other prescribed training. The exercise frequency was 3–4 times a week for 30–45 min each session.

Elastic-band Baduanjin exercise intervention group

In addition to the daily routine lifestyle, the intervention will be implemented by applying the constructed ‘Elastic-band Baduanjin exercise for older adults with type 2 diabetes mellitus’. Exercise was performed 3–4 times a week for 30–45 min each session.

The exercise programme will be conducted in two rounds. The first draft was developed through literature retrieval, review and expert meetings. Subsequently, a final draft was published to assess any concerns through field observation and a qualitative study was performed to collect patient experiences and feelings. The formulation process is illustrated in figure 2.

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Figure 2

The process of Baduanjin exercise combined with elastic band exercise training.

Pilot study

A convenience sampling method will be used to recruit 10 older adults from the Tangzhen Community Health Care Center for a 2-week feasibility study of Elastic-band Baduanjin exercise training. This study aimed to evaluate the acceptance of an exercise programme among older adults and to gain insight into and analyse the experiences and feelings of the patients. This study will evaluate patient compliance, safety and acceptance of the combined exercise programme through on-site observation and qualitative interview methods. Acceptance will be assessed in four areas: the ability to remember, acceptance of the difficulty of the movements, completion of movements to standards and suggestions or comments. The recruitment for this pilot study is currently underway. During the qualitative interviews, we found that older adults were more willing to accept interventions taking place in the morning in the community, which was in line with the resting habits of the participants. Therefore, appointments will be made to accommodate the time requested by patients, and attention will be paid to educating them on the health aspects of exercise with diabetes.

Outcome measures

All outcomes will be measured preintervention (within 1 week before the start date of the intervention) and postintervention (within 1 week after the intervention). Muscle strength is the primary outcome indicator (table 2).

Primary outcomes

Muscle strength has been used to determine muscle mass and function in older adults. Skeletal muscle index (kg/m²), upper and lower limb fat (kg), and muscle mass (kg) were determined using the Biospace Inbody 270 body composition analyser to determine changes before and after the intervention. Upper limb muscle strength was measured using a grip dynamometer (EH-101). Grip strength measurement (kg) is a simple and reproducible evaluation method. Lower limb muscle strength was measured the 30-second Chair Stand Test. The number of times the test was completed in 30 s was recorded.

Secondary outcomes

Balance function will be determined by the Berg Balance Scale, which is designed to assess balance ability. The scale consists of 14 items divided into 0–4 for 5 of the 56 points. The higher the score, the better the prompt balance function.

Exercise conditions will be assessed using the International Physical Activity Questionnaire consists of seven questions that measure the level of physical activity.

Sample size

Based on the muscle strength index study ‘Effects of combined aerobic resistance exercise on skeletal muscle morphology and function in women with type 2 diabetes mellitus’,29 25.46±3.02 participants for the control group and 28.27±4.15 participants for the intervention group, α=0.05 are estimated as the sample sizes required for the study. Considering the possible loss to follow-up rate of 20%, the sample size calculated by GPOWER V.3.1 software was 70 participants, with 35 participants in each group.

Data and statistical analysis

Data will be entered and evaluated by two researchers using EpiData V.3.1. Data will be entered into the SPSS 24.0 software for processing.

Frequency and percentages were used to describe sex, marriage and other counting data. Composition ratios describe grades such as educational attainment. For measurement data such as age, blood glucose and questionnaire score, data will be evaluated for normal distribution, normally distributed data will be expressed as mean and SD (χ±S), and non-normally distributed data will be expressed as the median (with IQR) (M[P25, P75]).

For the measurement data of the patients between the two groups, the data conforming to normality and uniform variance will be evaluated using the two independent samples t-test. Otherwise, the Mann-Whitney U test will be used. The χ² test will be used for the count data of the patients between the two groups.

For measurements that met normality and uniform variance for patients within groups, paired samples t-test will be used. Otherwise, the Wilcoxon rank-sum test will be used. The χ² test will be used to count patients’ data within groups. For participants who drop out before the end of 12 weeks, all exclusions and discharges will be analysed by the ‘Intent Therapy’ approach at the end of the trial. Data loss to follow-up processing, for missing completely, observation cases containing missing values will be removed depending on the occurrence, such as loss of follow-up caused by patients moving away from the centre or for work-related reasons. Direct deletion will be used for missing values when the missing data are concentrated in a few individuals, and multiple imputations will be used in other cases. When comparing the outcome indicators of the two groups of patients before and after the intervention, since the initial level of the outcome indicators could not be controlled and might interfere with the results, the analysis of covariance will be used to avoid the influence of this uncontrollable factor.

Ethics and dissemination

The trial was approved by the Chinese Ethics Committee of Registering Clinical Trials on 19 June 2022 (ChiECRCT20220210). All participants will provide informed written consent prior to commencing the study. We are committed to conducting research in accordance with the Declaration of Helsinki. The research results will be published in peer-­reviewed publications.

Trial status

The expert meeting on the formation of the first draft of Elastic-band Baduanjin exercise training was completed and held in April 2022. A pilot study was conducted during the recruitment phase.