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

Not Applicable

Recruiting

• Conditions: Older Adults With a History of Falls
• Interventions: Behavioral: Exercise; Behavioral: Active Control

• Registration Number: NCT06378164
• Lead Sponsor: The Hong Kong Polytechnic University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-21
• Study Start: 2023-12-01
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-17
• Last Update Submitted: 2024-04-17
• Study First Posted: 2024-04-22
• Last Update Posted: 2024-04-22
• Primary Completion: 2025-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 98

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combined volitional and reactive step training	Exercise	-
Non-specific exercise group	Active Control	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Mini Balance Evaluation System 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
Prospective Falls	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.
Programme Adherence	From start to six months after the end of training	The attendance of the exercise class will be recorded.
Adverse Events	From start to six months after the end of training	Adverse events happened during the intervention will be recorded descriptively.
Motor Control Test	(i) baseline, (ii) immediately post-intervention, (iii) 3-months post-intervention and (iv) 6-months post-intervention

Trial Locations

Locations (1)

The Hong Kong Polytechnic University; 🇭🇰 Hong Kong, Hong Kong