Pilot Feasibility Study of a Fall Prevention Exercise Programme for Community-dwelling Older Adults in Nanchang, China
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Safety of the intervention (adverse events)
研究概览
简要总结
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:
- Is the Safe & Joyful Walk programme feasible and acceptable for older adults in urban China?
- Does the programme help participants stick to regular exercise?
- Does the programme show early signs of improving balance, walking speed, and reducing falls?
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:
- Attend 24 instructor-led group exercise sessions over 12 weeks
- Complete additional unsupervised home-based exercise practices during the same 12-week intervention period
- Continue unsupervised exercises during a 24-week follow-up period to assess long-term adherence
- Complete surveys, interviews, and physical tests at baseline, 12 weeks, and 36 weeks
- Record their exercise and any falls in diaries and calendars
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 60 years or older;
- •Mandarin-speaking;
- •independent in activities of daily living;
- •able to walk 10 m without the use of a walking aid;
- •willingness to provide informed consent and comply with the study protocol.
排除标准
- •an acute psychiatric condition with psychosis;
- •an unstable medical condition that would preclude safe participation;
- •a progressive neurological condition (such as Parkinson's disease, multiple sclerosis, Meniere's disease);
- •cognitive impairment defined as a Pfeiffer Short Portable Mental Status Questionnaire (SPMSQ) score <8 ;
- •residing in residential aged care, currently participating in a fall prevention trial.
研究组 & 干预措施
Safe & Joyful Walk
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.
干预措施: Safe & Joyful Walk (Behavioral)
Tai Chi
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.
干预措施: Tai Chi (Behavioral)
结局指标
主要结局
Safety of the intervention (adverse events)
时间窗: Baseline to 36 weeks.
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.
Recruitment rate
时间窗: Up to 4 weeks
Recruitment will be assessed by the proportion of eligible participants enrolled, recorded in the Study Screening Log.
Attrition rate
时间窗: Baseline to 36 weeks
Attrition will be assessed by the proportion of participants who withdraw before completing the 36-week follow-up, recorded in the Withdrawal Log.
Fall rate
时间窗: Baseline to 36 weeks
Falls will be tracked using participant fall calendars with monthly telephone verification; outcomes include number of falls and fallers over the 36-week period.
次要结局
- Attendance at group sessions(Baseline to 12 weeks)
- Adherence to home-based practice(Baseline to 36 weeks)
- Balance confidence (Activity-specific Balance Confidence Scale, ABC)(Baseline, 12 weeks and 36 weks)
- Gait speed (4-meter gait speed test)(Baseline, 12 weeks and 36 weeks.)
- Balance performance (One-Leg Stance test)(Baseline, 12 weeks and 36 weeks.)