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

NCT06378164 | Recruiting

• 1 other identifier: P0041406
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Older Adults With a History of Falls

Keywords

Falls; Exercise; Randomised Trial; Step Training; Reaction

Outcome Measures

Primary Outcomes (2)

• Choice Stepping Reaction Times

  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

  To assess reactive stepping performance

  (i) baseline, (ii) immediately post-intervention, (iii) 3-months post-intervention and (iv) 6-months post-intervention

Secondary Outcomes (7)

• Mini Balance Evaluation System Test

  (i) baseline, (ii) immediately post-intervention, (iii) 3-months post-intervention and (iv) 6-months post-intervention

• Motor Control Test

  (i) baseline, (ii) immediately post-intervention, (iii) 3-months post-intervention and (iv) 6-months post-intervention

• Falls Efficacy Scale - International

  (i) baseline, (ii) immediately post-intervention, (iii) 3-months post-intervention and (iv) 6-months post-intervention

• Trail-Making Test

  (i) baseline, (ii) immediately post-intervention, (iii) 3-months post-intervention and (iv) 6-months post-intervention

• Programme Adherence

  From start to six months after the end of training

Study Arms (2)

Combined volitional and reactive step training

EXPERIMENTAL

Behavioral: Exercise

Non-specific exercise group

PLACEBO COMPARATOR

Behavioral: Active Control

Interventions

Exercise BEHAVIORAL

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.

Combined volitional and reactive step training

Active Control BEHAVIORAL

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.

Non-specific exercise group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• Chinese University of Hong Kong: collaborator
• Neuroscience Research Australia: collaborator
• The University of New South Wales: collaborator

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Freddy Man Hin LAM, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Freddy Man Hin LAM, PhD

CONTACT

2766 6720; freddy-mh.lam@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: April 22, 2024
• Study Start: December 1, 2023
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2026
• Last Updated: April 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: From Dec 2026 onward
• Access Criteria: By contacting the Principal Investigator (Dr Freddy Lam): Freddy-mh.lam@polyu.edu.hk

Locations

HK (1)