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

April 28, 2026 updated by: University of Malaya

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Jiangxi
      • Nanchang, Jiangxi, China, 330098
        • QingShanHu University for the Elderly

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Behavioral: Safe & Joyful Walk
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.
Active Comparator: 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.
Behavioral: Tai Chi
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline to 36 weeks.
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.
Up to 4 weeks
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.
Baseline to 36 weeks
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.
Baseline to 36 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline to 12 weeks
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.
Baseline to 36 weeks
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.
Baseline, 12 weeks and 36 weks
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.
Baseline, 12 weeks and 36 weeks.
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.
Baseline, 12 weeks and 36 weeks.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
Week 12 and week 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Malaya

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 16, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 4, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 14, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UM.TNC2/UMREC_3210

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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