NCT06563661

Brief Summary

This study is a fully-powered randomised controlled trial and an essential follow-up study of our pilot work. The 21-style specific dance intervention to improve the balance and reduce the risks of falls (SDIIBRF) was suggested to be interesting, achievable, and compliable, according to the participants' feedback in the investigators' pilot work. Due to the expertly-designed and specifically-designed characteristics of the 21 dance styles in the SDIIBRF for improving balance and reducing risk of falls in older adults, the dance steps included in the SDIIBRF are unique and are largely different from the dance interventions that have already been reported in the literature. Based on the encouraging results of the preliminary efficacy in the investigators' pilot work and dance being a mind-body exercise, the investigators hypothesise that the specific dance programme will be efficacious in reducing the frequency of falls (primary outcome measure), improving the balance (secondary outcome measure for the main fall risk factor), and reducing the physical and psychological fall risk factors (secondary outcome measures) in Hong Kong's at-risk older adults. The findings could provide important new evidence for a feasible option for older adults as an innovative fall prevention exercise programme. The research question is "Can the 21-style SDIIBRF reduce the frequency of falls, improve the balance, and reduce the fall risks in Hong Kong's older adults at moderate to high risk of falling? Therefore, the aim of this proposed study is to examine the efficacy of the 21-style SDIIBRF in reducing the frequency of falls, improving the balance, and reducing the fall risks in Hong Kong's older adults by comparing it with a wait-list control.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress96%
Dec 2024May 2026

First Submitted

Initial submission to the registry

August 16, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 21, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Last Updated

August 23, 2024

Status Verified

August 1, 2024

Enrollment Period

1.5 years

First QC Date

August 16, 2024

Last Update Submit

August 21, 2024

Conditions

Keywords

EfficacyDance programmeFalls preventionOlder adultsBalanceRisk of fallingFall risk factorsHong Kong SARRandomised controlled trial

Outcome Measures

Primary Outcomes (3)

  • Baseline Frequency of Falls

    A fall will be counted if it will cause our participant(s) unintentionally coming to rest on the ground or other lower level.

    Day 0

  • Changes from Baseline Frequency of Falls at 12 weeks

    A fall will be counted if it will cause our participant(s) unintentionally coming to rest on the ground or other lower level.

    Week 12

  • Changes from Baseline Frequency of Falls at 24 weeks

    A fall will be counted if it will cause our participant(s) unintentionally coming to rest on the ground or other lower level.

    Week 24

Secondary Outcomes (31)

  • Baseline Balance Ability

    Day 0

  • Changes from Baseline Balance Ability at 12 weeks

    Week 12

  • Changes from Baseline Balance Ability at 24 weeks

    Week 24

  • Baseline Functional Gait and Balance Assessment

    Day 0

  • Changes from Baseline Functional Gait and Balance Assessment at 12 weeks

    Week 12

  • +26 more secondary outcomes

Study Arms (2)

Dance group (DANG)

EXPERIMENTAL

The participants in DANG will participate in 12 dance training sessions with the 21-style specific dance exercises (\~120 minutes each with rest breaks) in a group once a week for 12 weeks.

Other: The 21-style specific dance exercises

Wait-list control group (WLCG)

ACTIVE COMPARATOR

The participants in the WLCG will be provided a fall prevention pamphlet with a set of conventional fall prevention exercises (e.g., including a set of balance, walking, and resistance exercises) at the start and will receive the training from the 21-style specific dance exercises after three scheduled assessment sessions with two waiting periods of 12 weeks and 3 months in between.

Other: The 21-style specific dance exercises

Interventions

The 21 dance styles (dance in a group), chosen and modified from seven dance styles, including cha-cha, jive, rumba, salsa, waltz, tango, and macarena, were developed by a group of experienced dance and rehabilitation experts and have been previously practised by a group of older adults in our pilot work, demonstrating good feasibility and positive participants' feedback.

Dance group (DANG)Wait-list control group (WLCG)

Eligibility Criteria

Age65 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • age 65 or above;
  • a total score of less than 25/28 in the Tinetti Performance Oriented Mobility Assessment (POMA) scale.

You may not qualify if:

  • a total score of less than 24/30 in the Chinese version of the Mini-Mental State Examination (MMSE-C);
  • the existence of any untreated cerebral vascular disease, Parkinson's disease, or any other major neurological deficit;
  • the existence of any medical condition that can affect their safety during dance training sessions;
  • unable to stand independently for at least 15 minutes without a walking aid;
  • unable to walk independently indoor for at least 20 metres without a walking aid;
  • previous experience of dance training;
  • currently participating in any other formal exercise programme.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomson Wong

Hong Kong, China

Location

Study Officials

  • Thomson Wong, PhD, BScPT

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomson Wong, PhD, BScPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A randomised, controlled (wait-list control), and two-armed trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2024

First Posted

August 21, 2024

Study Start

December 1, 2024

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2026

Last Updated

August 23, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations