RecruitingNot ApplicableNCT06774508

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

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

Sponsor

Umeå University

Enrollment

33 participants

Start Date

Feb 17, 2025

Study Type

INTERVENTIONAL

Conditions

Accidental Falls Cognition Postural Balance Gait

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.

Eligibility

Min Age: 75 Years

Inclusion Criteria4

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 Criteria3

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)

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Interventions

OTHERHIFE+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.

OTHERHIFE

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.