Feasibility of High-intensity Functional Exercise with Simultaneous Cognitive Challenge for Older People with Falls Risk

Not Applicable

Recruiting

• Conditions: Accidental Falls; Postural Balance; Gait; Cognition

• Registration Number: NCT06774508
• Lead Sponsor: Umeå University

Brief Summary

This study aims to evaluate the feasibility of a high-intensity functional exercise program with simultaneous cognitive challenge (HIFE+cog) among older people at risk of falls. The evaluation design and intervention development will be assessed with the following specific aims:

1. To investigate the acceptability and safety of the HIFE+cog program in older people at risk of falls, and the methods used in the study by evaluating recruitment, compliance with the intervention, severity of adverse events reported, and participant experiences.

2. To measure key outcome variables, including completion rates, missing data, estimates, variances, and 95% confidence intervals for between-group differences.

The study is designed as a randomized controlled pilot trial. Eligible participants will be randomized to either the intervention group (HIFE+cog) or the active control group (HIFE) to partake in individually tailored exercise, supervised and progressed by a physiotherapist, two times per week for 3 months.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-07
• Study First Submitted QC: 2025-01-11
• Study First Posted: 2025-01-14
• Status Verified: 2025-02
• Study Start: 2025-02-17
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-25
• Primary Completion: 2025-09-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• aged 75 years or older
• moderate risk of falling (feeling unsteady or afraid of falling, or having fallen in the past year, with a self-selected gait speed ≤0,8 m/s or TUG >15 s without walking aid)
• can walk independently indoors, without a walking aid
• can walk 500m independently outdoors, with or without a walking aid

Exclusion Criteria

• a high fall risk (≥2 falls in the past year, serious injury e.g. hip fracture from a fall in the past year requiring medical care, or inability to get up from the floor after a fall)
• Mini-Mental State Examination (MMSE) score <24 or dementia diagnosis
• a medical condition that may affect participation in high-intensity gait, balance, and leg strength exercise, or other movement-related conditions affecting exercise or tests (e.g., pain, dizziness, visual or hearing impairment)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Recruitment	Before intervention start	Rate of recruited participants, and sources for recruitment
Adherence	Through the 3-month intervention	Number of exercise sessions attended
Exercise intervention content and delivery	Through the 3-month intervention	Number of exercises, sets, repetitions, and intensity achieved measured using a standardized exercise diary completed by supervisors after each session
Retention	Through the 3-month intervention	Number of participants that completed follow-ups
Safety	Through the 3-month intervention period	Adverse events, including falls and discomfort reported during or between sessions by participants or supervisors, and measured using a standardized exercise diary completed by supervisors after each session
Occupational performance	Baseline, 3 months	The Canadian Occupational Performance Measure (COPM)
Balance and gait capacity	Baseline, 3 months	The 30-s Chair stand test
Cognitive function	Baseline, 3 months	The Mindmore cognitive battery: Executive function (verbal fluency) with The FAS test
Experiences of the intervention and effects	3 months	Individual interviews with participants in the intervention group

Secondary Outcome Measures

Name	Time	Method
Fear of falling	Baseline, 3 months	The Falls Self-Efficacy Scale (FES-I)
Psychological wellbeing	Baseline, 3 months	The Philadelphia Geriatric Center Morale Scale (PGCMS)
Physical activity	Baseline, 3 months	The International Physical Activity Questionnaire-Elderly (IPAQ-E)
Depressive disorders	Baseline, 3 months	The Geriatric Depression Scale (GDS-15)
Health related quality of life	Baseline, 3 months	The EQ5D, Selected questions from The short form (36) Health survey
Activities of daily life (ADL)	Baseline, 3 months	The Katz ADL Index
Descriptive information	Baseline	Age, gender, education, living conditions, past and current medical conditions and medications from self-reported questionnaire

Trial Locations

Locations (1)

Umeå University; 🇸🇪 Umeå, Sweden