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

NCT06774508 | Recruiting DMC

• 1 other identifier: Dnr 2024-07683-01
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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. 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. 2.To measure key outcome variables, including completion rates, missing data, estimates, variances, and 95% confidence intervals for between-group differences.

Conditions

Accidental Falls; Postural Balance; Gait; Cognition

Keywords

Accidental falls; Postural balance; Gait; Cognition; Exercise therapy; Resistance training; Aged

Outcome Measures

Primary Outcomes (18)

• Recruitment

  Rate of recruited participants, and sources for recruitment

  Before intervention start

• Adherence

  Number of exercise sessions attended

  Through the 3-month intervention

• 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

  Through the 3-month intervention

• Retention

  Number of participants that completed follow-ups

  Through the 3-month intervention

• Safety

  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

  Through the 3-month intervention period

• Balance and gait capacity

  The Timed up and go (TUG) test, with and without cognitive task

  Baseline, 3 months

• Balance and gait capacity

  The 4m forward gait speed test, with and without cognitive task

  Baseline, 3 months

• Balance and gait capacity

  The 4m backward gait speed test

  Baseline, 3 months

• Balance and gait capacity

  The Berg balance scale

  Baseline, 3 months

• Balance and gait capacity

  The 30-s Chair stand test

  Baseline, 3 months

• Cognitive function

  The Mindmore cognitive battery: Mental speed with The Symbol-Digit Processing test

  Baseline, 3 months

• Cognitive function

  The Mindmore cognitive battery: Mental speed with The Reaction test I and II

  Baseline, 3 months

• Cognitive function

  The Mindmore cognitive battery: Attention and executive function (shifting) with The Trail making test - Click (TMT-Click)

  Baseline, 3 months

• Cognitive function

  The Mindmore cognitive battery: Short term- and working memory with The Corsi Block test

  Baseline, 3 months

• Cognitive function

  The Mindmore cognitive battery: Executive function (inhibition) with The Stroop test

  Baseline, 3 months

• Cognitive function

  The Mindmore cognitive battery: Executive function (verbal fluency) with The FAS test

  Baseline, 3 months

• Occupational performance

  The Canadian Occupational Performance Measure (COPM)

  Baseline, 3 months

• Experiences of the intervention and effects

  Individual interviews with participants in the intervention group

  3 months

Secondary Outcomes (7)

• 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

Study Arms (2)

High-intensity functional exercise with cognitive challenge (HIFE+Cog)

EXPERIMENTAL

High intensity functional exercise (HIFE+Cog) program with simultaneous cognitive challenge, individually tailored and performed twice weekly for 12 weeks, in supervised groups.

Other: HIFE+cog

High-intensity functional exercise (HIFE)

ACTIVE COMPARATOR

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

Other: HIFE

Interventions

HIFE+cog 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 with cognitive challenge (HIFE+Cog)

HIFE 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.

High-intensity functional exercise (HIFE)

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Umeå University: lead
• Region Västerbotten: collaborator

Study Sites (1)

Umeå University

Umeå, 90187, Sweden

RECRUITING

Study Officials

• Annika Toots, PhD

  Umeå University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annika Toots, PhD

CONTACT

0046 90 7866329; annika.toots@umu.se

Magdalena Eriksson Domellöf, PhD

CONTACT

0046 90 7867022; magdalena.domellof@umu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded to group allocation. Participants will receive repeated instructions not to disclose their group allocation to the assessors.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 14, 2025
• Study Start: February 17, 2025
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)