Fall PreventionNCT07341802
Pilot Feasibility Study of a Fall Prevention Exercise Programme for Community-dwelling Older Adults in Nanchang, China
A study testing Safe & Joyful Walk and Tai Chi in people with Fall Prevention, run by University of Malaya at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fall Prevention
- What is being tested?
- Safe & Joyful Walk and Tai Chi
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 16 Mar 2026to 30 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
- 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
- Conditions
- Fall Prevention
- Being tested
- Safe & Joyful Walk, Tai Chi
- Keywords
- Fall prevention, Exercise adherence, Older adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safe & Joyful WalkBehavioural
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 ChiBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Safe & Joyful Walk |
| 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. Receives: Behavioral: Tai Chi |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 36 weeks.
Recruitment rate
Recruitment will be assessed by the proportion of eligible participants enrolled, recorded in the Study Screening Log.
Measured: 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.
Measured: 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.
Measured: Baseline to 36 weeks
Secondary outcomes (5)
Attendance at group sessions
Attendance will be assessed by the number and proportion of sessions attended, recorded in Attendance Logs.
Measured: Baseline to 12 weeks
Adherence to home-based practice
Adherence will be assessed using Exercise Diaries, documenting frequency and duration of home-based practice.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 12 weeks and 36 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start16 Mar 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fall PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07341802
- Sponsor's protocol ID
- UM.TNC2/UMREC_3210
- Status last verified
- Sep 2025
- First submitted
- 4 Dec 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Feasibility Study of a Fall Prevention Exercise Programme for Community-dwelling Older Adults in Nanchang, China
- ClinicalTrials.gov ID
- NCT07341802
- Acronym / sponsor ID
- UM.TNC2/UMREC_3210
- Conditions
- Fall Prevention
- Keywords
- Fall prevention, Exercise adherence, Older adults
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 16 Mar 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Safe & Joyful Walk | Experimental | Behavioral: Safe & Joyful WalkParticipants 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 | Behavioral: Tai ChiParticipants 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Safe & Joyful WalkA 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. | Behavioural | Safe & Joyful Walk |
| Tai ChiA 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. | Behavioural | Tai Chi |
Primary outcome
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.
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.
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.
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.
5 secondary outcomes
Attendance at group sessions
Time frame: Baseline to 12 weeks
Adherence to home-based practice
Time frame: Baseline to 36 weeks
Balance confidence (Activity-specific Balance Confidence Scale, ABC)
Time frame: Baseline, 12 weeks and 36 weks
Gait speed (4-meter gait speed test)
Time frame: Baseline, 12 weeks and 36 weeks.
Balance performance (One-Leg Stance test)
Time frame: Baseline, 12 weeks and 36 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
Related trials for Fall Prevention
Active, not recruiting
Impact of Screening and Multicomponent Exercise on Fall Rates, Fractures, and Cardiovascular Health in Diabetes
Type 2 Diabetes, Osteoporosis
Recruiting
Fall Risk Assessment and Speech Intelligibility Enhancement Using In-ear Device
Hearing Loss, Dizziness
Not yet recruiting
Multicomponent Exercise and Pain Science Education for Fall Prevention in Older Adults With Chronic Musculoskeletal Pain (MovePainFall)
Chronic Pain, Musculoskeletal Pain
Not yet recruiting
Exercise and Fall Prevention
Osteopenia, Osteoporosis
Recruiting
Effects of a Community-based Multicomponent Physical Exercise Program on Physical Function, Frailty, and Sarcopenia in Older Adults From the Municipality of Santoña: a Quasi-experimental Study.
Frailty/Sarcopenia, Frailty in Older Adults
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Safe & Joyful Walk and Tai Chi in people with Fall Prevention, run by University of Malaya at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of the intervention (adverse events) (time frame: Baseline to 36 weeks.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.