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The goal of this pilot clinical trial is to evaluate the feasibility of a fall prevention exercise programme for older adults living in urban communities in China. The study will also gather preliminary data on whether the programme can improve adherence to exercise and reduce falls.
The main questions it aims to answer are:
Researchers will compare the Safe & Joyful Walk programme to Tai Chi to see which approach may better support exercise adherence and fall prevention.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Safe & Joyful Walk | Experimental | Participants will attend 24 instructor-led group sessions over 12 weeks, focusing on balance, strength, and functional exercises. In addition, they will complete unsupervised home-based practices so that, together with the group sessions, they achieve the weekly target of 120 minutes of exercise. Instructional videos, printed manuals, and WeChat reminders will support independent practice. |
|
| Tai Chi | Active Comparator | Participants will attend 24 instructor-led group sessions over 12 weeks, practicing 24-form simplified Yang-style Tai Chi. In addition, they will complete unsupervised home-based practices so that, together with the group sessions, they achieve the weekly target of 120 minutes of exercise. Instructional videos, printed manuals, and WeChat reminders will support independent practice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Safe & Joyful Walk | Behavioral | A 12-week group-based exercise programme designed to improve balance, strength, and functional mobility. Participants attend 24 instructor-led sessions and complete additional home-based practices, with the combined duration of group and home sessions reaching the target of 120 minutes of exercise per week. Instructional videos, printed manuals, and WeChat reminders support adherence. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of the intervention (adverse events) | Safety will be assessed by the number and type of adverse events reported by participants and recorded in exercise diaries throughout the 12-week programme and 24-week follow-up. | Baseline to 36 weeks. |
| Recruitment rate | Recruitment will be assessed by the proportion of eligible participants enrolled, recorded in the Study Screening Log. | Up to 4 weeks |
| Attrition rate | Attrition will be assessed by the proportion of participants who withdraw before completing the 36-week follow-up, recorded in the Withdrawal Log. | Baseline to 36 weeks |
| Fall rate | Falls will be tracked using participant fall calendars with monthly telephone verification; outcomes include number of falls and fallers over the 36-week period. | Baseline to 36 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Attendance at group sessions | Attendance will be assessed by the number and proportion of sessions attended, recorded in Attendance Logs. | Baseline to 12 weeks |
| Adherence to home-based practice |
| Measure | Description | Time Frame |
|---|---|---|
| Socio-demographic and clinical characteristics | Socio-demographic and clinical characteristics-including age, sex, education level, and 12-month fall history-will be collected using the Demographic Information and Fall History Form. These variables will be summarized using descriptive statistics (e.g., means and standard deviations for continuous variables; frequencies and percentages for categorical variables) to describe the study sample. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| QingShanHu University for the Elderly | Nanchang | Jiangxi | 330098 | China |
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| ID | Term |
|---|---|
| D026302 | Tai Ji |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026241 | Exercise Movement Techniques |
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In addition to outcomes assessors, the data analysts are masked to group allocation. The dataset provided for analysis uses coded group labels ("Group A" and "Group B"), and the analysts remain blinded until after the primary analyses are complete.
|
| Tai Chi | Behavioral | A 12-week group-based Tai Chi programme using the simplified 24-form Yang-style routine. Participants attend 24 instructor-led sessions and complete additional home-based practices, with the combined duration of group and home sessions reaching the target of 120 minutes of exercise per week. Instructional videos, printed manuals, and WeChat reminders support adherence. |
|
Adherence will be assessed using Exercise Diaries, documenting frequency and duration of home-based practice.
| Baseline to 36 weeks |
| Balance confidence (Activity-specific Balance Confidence Scale, ABC) | Balance confidence will be assessed using the Activity-specific Balance Confidence (ABC) Scale, a 16-item self-report questionnaire measuring confidence in performing daily activities without losing balance. Scores range from 0% to 100%, with higher scores indicating greater balance confidence. | Baseline, 12 weeks and 36 weks |
| Gait speed (4-meter gait speed test) | Usual gait speed will be measured over 4 meters using standardized procedures; faster speed indicates better performance. | Baseline, 12 weeks and 36 weeks. |
| Balance performance (One-Leg Stance test) | Static balance will be assessed using the One-Leg Stance test; longer stance time indicates better balance. | Baseline, 12 weeks and 36 weeks. |
| Baseline |
| Programme acceptability | Programme acceptability will be assessed using a structured questionnaire and semi-structured interviews. The questionnaire consists of five yes/no items addressing satisfaction, perceived benefits, interest, fatigue, and willingness to continue the programme. Quantitative acceptability will be determined by calculating the proportion of affirmative ("Yes") responses; if at least 50% of the responses are affirmative, the programme will be considered acceptable. Qualitative acceptability will be explored through semi-structured interviews to capture participants' experiences, perceived benefits, and barriers to participation. | Week 12 and week 36 |
| D026741 |
| Physical Therapy Modalities |