The Feasibility of a High-intensity Functional Exercise Program with Simultaneous Cognitive Challenge to Improve Physical and Cognitive Function in Older People with Intermediate Risk for Falls: a Randomized Controlled Pilot Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Umeå University
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Balance and gait capacity
Study Overview
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:
- 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.
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Masking Description
Outcome assessors will be blinded to group allocation. Participants will receive repeated instructions not to disclose their group allocation to the assessors.
Eligibility Criteria
- Ages
- 75 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
High-intensity functional exercise with cognitive challenge (HIFE+Cog)
High intensity functional exercise (HIFE+Cog) program with simultaneous cognitive challenge, individually tailored and performed twice weekly for 12 weeks, in supervised groups.
Intervention: HIFE+cog (Other)
High-intensity functional exercise (HIFE)
High intensity functional exercise (HIFE) program, individually tailored and performed twice weekly for 12 weeks, in supervised groups.
Intervention: HIFE (Other)
Outcomes
Primary Outcomes
Balance and gait capacity
Time Frame: Baseline, 3 months
The Timed up and go (TUG) test, with and without cognitive task
Cognitive function
Time Frame: Baseline, 3 months
The Mindmore cognitive battery: Mental speed with The Symbol-Digit Processing test
Recruitment
Time Frame: Before intervention start
Rate of recruited participants, and sources for recruitment
Adherence
Time Frame: Through the 3-month intervention
Number of exercise sessions attended
Exercise intervention content and delivery
Time Frame: 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
Time Frame: Through the 3-month intervention
Number of participants that completed follow-ups
Safety
Time Frame: 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
Time Frame: Baseline, 3 months
The Canadian Occupational Performance Measure (COPM)
Experiences of the intervention and effects
Time Frame: 3 months
Individual interviews with participants in the intervention group
Secondary Outcomes
- Fear of falling(Baseline, 3 months)
- Psychological wellbeing(Baseline, 3 months)
- Physical activity(Baseline, 3 months)
- Depressive disorders(Baseline, 3 months)
- Health related quality of life(Baseline, 3 months)
- Activities of daily life (ADL)(Baseline, 3 months)
- Descriptive information(Baseline)
Investigators
Annika Toots
Associate professor
Umeå University