Optimal Intensity of Reactive Balance Training for Healthy Older Adults

Falls in daily life are a serious risk for older adults. A new type of balance training, called reactive balance training (RBT) involves people losing balance many times so that they can practice fast balance reactions, like stepping reactions. Differences in training program features might explain differences in the results of previous RBT studies. Training intensity is the difficulty or challenge of the training program. It would be valuable to know if high-intensity RBT improves balance reactions quickly. The main goal of this study is to see if more intense RBT improves balance reactions faster than less intense RBT. The investigators will compare how quickly people improve balance reactions between high- and moderate-intensity RBT, and between RBT and a control program that does not include RBT. The investigators will also test if the improvements in balance reactions last after the training program is over. The secondary goals are to understand exactly how balance reactions improve with training, and to determine if people who complete RBT improve their general balance skills, and falls efficacy more than people who do not complete RBT.

Study Overview

• Status: Recruiting
• Conditions: Accidental Falls
• Intervention / Treatment: Behavioral: Reactive balance training; Behavioral: Walking

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Avril Mansfield, PhD; Phone Number: 7831 416-597-3422; Email: avril.mansfield@uhn.ca
• Study Contact Backup: Name: David Jagroop; Phone Number: 7614 416-597-3422; Email: david.jagroop@uhn.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2A2
      • Recruiting
      • University Health Network
      • Contact: David Jagroop; Phone Number: 7614 416-597-3422; Email: david.jagroop@uhn.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Community-dwelling older adults (65-80 years old)

Exclusion Criteria:

• Unable to stand independently without upper-limb support for >30 seconds and/or walk independently (without a gait aid) for ≥10 metres;
• Diagnosed neurological condition that could affect balance control (e.g., stroke, Parkinson's disease);
• Score below normative values on the Montreal Cognitive Assessment;
• Score below age-matched normative values for sensory and motor function, as assessed using the FallScreen battery;
• Have insufficient English language comprehension such that they cannot understand instructions;
• Have contraindications to reactive balance training such as severe osteoporosis; and/or
• Are currently attending physiotherapy or supervised exercise.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High intensity reactive balance training; Participants will complete 5 1-hour training sessions over 11 days. During each training session, participants will complete 36 multi-directional (left-, right-, and forward-fall) perturbations. Participants assigned to high-intensity RBT will experience perturbations at 150% of the multi-step threshold; for example, for a multi-step threshold of 2 m/s^2 the high intensity perturbation will be 3 m/s^2.	Behavioral: Reactive balance training; Reactive balance training involves clients experiencing repeated balance perturbations so that they can practice and improve control of reactions to avoid falling after a loss of balance.; Other Names: Perturbation-based balance training
Active Comparator: Moderate intensity reactive balance training; Participants will complete 5 1-hour training sessions over 11 days. During each training session, participants will complete 36 multi-directional (left-, right-, and forward-fall) perturbations. Participants assigned to moderate-intensity RBT will experience perturbations at 100% of the multi-step threshold; for example, for a multi-step threshold of 2 m/s^2 the high intensity perturbation will be 2 m/s^2.	Behavioral: Reactive balance training; Reactive balance training involves clients experiencing repeated balance perturbations so that they can practice and improve control of reactions to avoid falling after a loss of balance.; Other Names: Perturbation-based balance training
Sham Comparator: Walking control group; Participants assigned to the walking control group will complete 36 trials of unperturbed walking in each training session.	Behavioral: Walking; Overground walking

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of reactive steps	Learning rate for number of steps to recover from 'backward fall' balance perturbations	Two weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Step initiation time	Time from perturbation onset time to foot off time	One week and 12 weeks post-training
Step execution time	Time from foot off to foot contact of the first step	One week and 12 weeks post-training
Step length	Difference in foot position from foot off to foot contact	One week and 12 weeks post-training
Braking impulse	Antero-posterior shear force generated over time on step contact	One week and 12 weeks post-training
Mechanical margin of stability	Distance between the extrapolated centre of mass (incorporating centre of mass position and velocity) and the edge of the base of support	One week and 12 weeks post-training
Balance evaluation systems test	Scale ranges from 0-100, with higher scores indicating better outcome	One week and 12 weeks post-training
Falls efficacy scale - International	Scale range: 10-100; higher values indicate worse outcome	One week, 12 weeks, and 12 months post-training

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fall incidence	Falls in daily life	12 months post-training
Injurious fall incidence		12-months post-training
5-level EuroQoL health status measure (EQ-5D-5L)	Scale range for descriptive component: 5-25, higher values indicate worse outcome; Scale range for visual analogue scale: 0-100, higher values indicate better outcome	One week, 12 weeks, and 12 months post-training
Number of participants with fear of falling		One week, 12 weeks, and 12 months post-training
Number of participants with activity curtailment due to fear of falling		One week, 12 weeks, and 12 months post-training

Collaborators and Investigators

• Sponsor: Toronto Rehabilitation Institute
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Principal Investigator: Avril Mansfield, PhD, University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: October 23, 2024
• First Submitted That Met QC Criteria: October 23, 2024
• First Posted (Actual): October 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 22, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Rehabilitation; Aging; Biomechanics; Postural balance
• Other Study ID Numbers: 24-5665

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No