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NCT Number: NCT07341802

Pilot Feasibility Study of a Fall Prevention Exercise Programme for Community-dwelling Older Adults in Nanchang, China

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Fall Prevention

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

QingShanHu University for the Elderly

Nanchang, Jiangxi, 330098, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Safety of the intervention (adverse events)

    Time frame: 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.

  2. Recruitment rate

    Time frame: Up to 4 weeks

    Recruitment will be assessed by the proportion of eligible participants enrolled, recorded in the Study Screening Log.

  3. Attrition rate

    Time frame: 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.

  4. Fall rate

    Time frame: 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.

Secondary outcomes

  1. Attendance at group sessions

    Time frame: Baseline to 12 weeks

    Attendance will be assessed by the number and proportion of sessions attended, recorded in Attendance Logs.

  2. Adherence to home-based practice

    Time frame: Baseline to 36 weeks

    Adherence will be assessed using Exercise Diaries, documenting frequency and duration of home-based practice.

  3. Balance confidence (Activity-specific Balance Confidence Scale, ABC)

    Time frame: Baseline, 12 weeks and 36 weks

    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.

  4. Gait speed (4-meter gait speed test)

    Time frame: Baseline, 12 weeks and 36 weeks.

    Usual gait speed will be measured over 4 meters using standardized procedures; faster speed indicates better performance.

  5. Balance performance (One-Leg Stance test)

    Time frame: Baseline, 12 weeks and 36 weeks.

    Static balance will be assessed using the One-Leg Stance test; longer stance time indicates better balance.

Other outcomes

  1. Socio-demographic and clinical characteristics

    Time frame: Baseline

    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.

  2. Programme acceptability

    Time frame: Week 12 and week 36

    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.

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jan 14, 2026
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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