NCT07341802

Brief 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. 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
9mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
Mar 2026Jan 2027

First Submitted

Initial submission to the registry

December 4, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 14, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2027

Last Updated

January 14, 2026

Status Verified

September 1, 2025

Enrollment Period

10 months

First QC Date

December 4, 2025

Last Update Submit

January 7, 2026

Conditions

Fall Prevention

Keywords

Fall preventionExercise adherenceOlder adults

Outcome Measures

Primary Outcomes (4)

  • 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

Secondary Outcomes (5)

  • 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.

Other Outcomes (2)

  • Socio-demographic and clinical characteristics

    Baseline

  • Programme acceptability

    Week 12 and week 36

Study Arms (2)

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.

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.

Behavioral: Tai Chi

Interventions

Safe & Joyful WalkBEHAVIORAL

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.

Safe & Joyful Walk
Tai ChiBEHAVIORAL

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.

Tai Chi

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

QingShanHu University for the Elderly

Nanchang, Jiangxi, 330098, China

RECRUITING

MeSH Terms

Interventions

Tai Ji

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Central Study Contacts

Bing Xu

CONTACT

+86-13951239191xu.bing121@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2025

First Posted

January 14, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

January 30, 2027

Last Updated

January 14, 2026

Record last verified: 2025-09

Locations

CN(1)