The Effect of Combined Volitional and Reactive Step Training in Reducing Falls Risk in Older Fallers

April 17, 2024 updated by: Freddy Man Hin LAM, The Hong Kong Polytechnic University

The Immediate and Sustained Effect of 4-week Combined Volitional and Reactive Step Training in Reducing Falls Risk in Community-Dwelling Older Fallers: a Randomised Controlled Trial

To examine the immediate and sustained effect of a 4-week combined volitional and reactive step training on fall risks in community-dwelling older fallers.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

98

Phase

  • 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 Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • The Hong Kong Polytechnic University
        • Contact:
        • Contact:
          • Freddy Man Hin LAM
        • Principal Investigator:
          • Freddy Man Hin LAM, PhD

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

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Community-dwelling
  • Able to walk for 1 minute under supervision without walking aids
  • Have a history of falling in the past year

Exclusion Criteria:

  • Cognitive impairment (i.e., scores below the age and education-specific cut-off of 7th percentile in the 5-minute Montreal cognitive assessment)
  • Blindness
  • Neurological conditions (e.g., stroke, Parkinson's disease)
  • Other serious illnesses that preclude participation in exercise training

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
Intervention / Treatment
Experimental: Combined volitional and reactive step training
Behavioral: Exercise
For the combined step training group, the participants will receive training on both volitional and reactive stepping. The training will last for 1 hours per session, 2 session per week for 4 weeks.
Placebo Comparator: Non-specific exercise group
Behavioral: Active Control
An active control group will be used to minimise the placebo and history effect. The group will also receive a 4-week programme with the frequency and duration of the training and the instructor-to-participant ratio that match the combined step training group. During training, they will perform exercises not specific to reducing fall risk.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Choice Stepping Reaction Times
Time Frame: (i) baseline, (ii) immediately post-intervention, (iii) 3-months post-intervention and (iv) 6-months post-intervention
To assess volitional stepping performance
(i) baseline, (ii) immediately post-intervention, (iii) 3-months post-intervention and (iv) 6-months post-intervention
Spring Scale Test
Time Frame: (i) baseline, (ii) immediately post-intervention, (iii) 3-months post-intervention and (iv) 6-months post-intervention
To assess reactive stepping performance
(i) baseline, (ii) immediately post-intervention, (iii) 3-months post-intervention and (iv) 6-months post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mini Balance Evaluation System Test
Time Frame: (i) baseline, (ii) immediately post-intervention, (iii) 3-months post-intervention and (iv) 6-months post-intervention
(i) baseline, (ii) immediately post-intervention, (iii) 3-months post-intervention and (iv) 6-months post-intervention
Motor Control Test
Time Frame: (i) baseline, (ii) immediately post-intervention, (iii) 3-months post-intervention and (iv) 6-months post-intervention
(i) baseline, (ii) immediately post-intervention, (iii) 3-months post-intervention and (iv) 6-months post-intervention
Falls Efficacy Scale - International
Time Frame: (i) baseline, (ii) immediately post-intervention, (iii) 3-months post-intervention and (iv) 6-months post-intervention
(i) baseline, (ii) immediately post-intervention, (iii) 3-months post-intervention and (iv) 6-months post-intervention
Trail-Making Test
Time Frame: (i) baseline, (ii) immediately post-intervention, (iii) 3-months post-intervention and (iv) 6-months post-intervention
(i) baseline, (ii) immediately post-intervention, (iii) 3-months post-intervention and (iv) 6-months post-intervention
Programme Adherence
Time Frame: From start to six months after the end of training
The attendance of the exercise class will be recorded.
From start to six months after the end of training
Prospective Falls
Time Frame: From start to 12 months after the intervention ends
Fall incidence and details on fall will be recorded using a fall diary and monthly follow-up.
From start to 12 months after the intervention ends
Adverse Events
Time Frame: From start to six months after the end of training
Adverse events happened during the intervention will be recorded descriptively.
From start to six months after the end of training

Collaborators and Investigators

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

Sponsor

The Hong Kong Polytechnic University

Collaborators

Chinese University of Hong Kong
The University of New South Wales
Neuroscience Research Australia

Investigators

  • Principal Investigator: Freddy Man Hin LAM, PhD, The Hong Kong Polytechnic University

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)

December 1, 2023

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

November 21, 2023

First Submitted That Met QC Criteria

April 17, 2024

First Posted (Actual)

April 22, 2024

Study Record Updates

Last Update Posted (Actual)

April 22, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • P0041406

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The study data can be provided via contacting the Principal Investigator

IPD Sharing Time Frame

From Dec 2026 onward

IPD Sharing Access Criteria

By contacting the Principal Investigator (Dr Freddy Lam): Freddy-mh.lam@polyu.edu.hk

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

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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