Feasibility of High-intensity Functional Exercise with Simultaneous Cognitive Challenge for Older People with Falls Risk
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HIFE+cog, HIFE.
- Who it may be relevant to
- Registry conditions: Accidental Falls, Postural Balance, Gait, Cognition. Basic parameters: from 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- Other HIFE+cog
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. - Other HIFE
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.
Primary outcome measures
- Recruitment [Time frame: Before intervention start]
- Adherence [Time frame: Through the 3-month intervention]
- Exercise intervention content and delivery [Time frame: Through the 3-month intervention]
- Retention [Time frame: Through the 3-month intervention]
- Safety [Time frame: Through the 3-month intervention period]
- Balance and gait capacity [Time frame: Baseline, 3 months]
- Balance and gait capacity [Time frame: Baseline, 3 months]
- Balance and gait capacity [Time frame: Baseline, 3 months]
- Balance and gait capacity [Time frame: Baseline, 3 months]
- Balance and gait capacity [Time frame: Baseline, 3 months]
Secondary outcome measures (7)
- Fear of falling [Time frame: Baseline, 3 months]
- Psychological wellbeing [Time frame: Baseline, 3 months]
- Physical activity [Time frame: Baseline, 3 months]
- Depressive disorders [Time frame: Baseline, 3 months]
- Health related quality of life [Time frame: Baseline, 3 months]
- Activities of daily life (ADL) [Time frame: Baseline, 3 months]
- Descriptive information [Time frame: Baseline]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Sweden · 1 center
- Umeå University — Umeå
Identifiers
NCT: NCT06774508 · Dnr 2024-07683-01