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

NCT ID: NCT06774508

Last Updated: 2025-02-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-17
• Study Completion Date: 2025-09-01

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.

Conditions

Accidental Falls; Postural Balance; Gait; Cognition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

HIFE+cog

Intervention Type: OTHER

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.

High-intensity functional exercise (HIFE)

High intensity functional exercise (HIFE) program, individually tailored and performed twice weekly for 12 weeks, in supervised groups.

Group Type: ACTIVE_COMPARATOR

HIFE

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Västerbotten

OTHER_GOV

Sponsor Role: collaborator

Umeå University

OTHER

Sponsor Role: lead

Responsible Party

Annika Toots

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Annika Toots, PhD

Role: PRINCIPAL_INVESTIGATOR

Umeå University

Locations

Umeå University

Umeå, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Annika Toots, PhD

Role: CONTACT

annika.toots@umu.se

0046 90 7866329

Magdalena Eriksson Domellöf, PhD

Role: CONTACT

magdalena.domellof@umu.se

0046 90 7867022

Facility Contacts

Annika Toots, PhD

Role: primary

annika.toots@umu.se

0046907866329

Other Identifiers

Dnr 2024-07683-01

Identifier Type: -

Identifier Source: org_study_id