Health TrialsbyHealthPanel

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

ConditionsAccidental FallsPostural BalanceGaitCognition
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age75+
SponsorUmeå University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • HIFE+cog

    Other intervention

    Each session will consist of individually tailored exercises performed at weight- bearing positions and covering lower leg strengthening exercises, as well as static- and dynamic balance exercises. Simultaneous cognitive exercises are added to static and dynamic balance exercises. Relative exercise intensity is encouraged to be moderate to high, and progressively adjusted by for example altering load or difficulty of the exercise. Session duration is 1 hour, including warm-up.

  • HIFE

    Other intervention

    Each session will consist of individually tailored exercises performed at weight- bearing positions and covering lower leg strengthening exercises, as well as static- and dynamic balance exercises. Relative exercises intensity is encouraged to be moderate to high, and progressively adjusted by for example altering load or difficulty of the exercise. Session duration is 1 hour, including warm-up.

Treatment groups

33 Participants
are divided into 2 treatment groups
Group A: High-intensity functional exercise with cognitive challenge (HIFE+Cog)Experimental treatment 1 intervention
Group B: High-intensity functional exercise (HIFE)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Recruitment

Rate of recruited participants, and sources for recruitment

Time frame
Before intervention start
2

Adherence

Number of exercise sessions attended

Time frame
Through the 3-month intervention
3

Exercise intervention content and delivery

Number of exercises, sets, repetitions, and intensity achieved measured using a standardized exercise diary completed by supervisors after each session

Time frame
Through the 3-month intervention
4

Retention

Number of participants that completed follow-ups

Time frame
Through the 3-month intervention

Secondary outcomes

1

Fear of falling

The Falls Self-Efficacy Scale (FES-I)

Time frame
Baseline, 3 months
2

Psychological wellbeing

The Philadelphia Geriatric Center Morale Scale (PGCMS)

Time frame
Baseline, 3 months
3

Physical activity

The International Physical Activity Questionnaire-Elderly (IPAQ-E)

Time frame
Baseline, 3 months
4

Depressive disorders

The Geriatric Depression Scale (GDS-15)

Time frame
Baseline, 3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Umeå University

Lead sponsor

Region Västerbotten

Collaborator

Source ClinicalTrials.gov
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