Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06774508

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Accidental Falls Cognition Gait Postural Balance

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

Primary outcomes

  1. Recruitment

    Time frame: Before intervention start

    Rate of recruited participants, and sources for recruitment

  2. Adherence

    Time frame: Through the 3-month intervention

    Number of exercise sessions attended

  3. Exercise intervention content and delivery

    Time frame: Through the 3-month intervention

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

  4. Retention

    Time frame: Through the 3-month intervention

    Number of participants that completed follow-ups

  5. Safety

    Time frame: Through the 3-month intervention period

    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

  6. Balance and gait capacity

    Time frame: Baseline, 3 months

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

  7. Balance and gait capacity

    Time frame: Baseline, 3 months

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

  8. Balance and gait capacity

    Time frame: Baseline, 3 months

    The 4m backward gait speed test

  9. Balance and gait capacity

    Time frame: Baseline, 3 months

    The Berg balance scale

  10. Balance and gait capacity

    Time frame: Baseline, 3 months

    The 30-s Chair stand test

  11. Cognitive function

    Time frame: Baseline, 3 months

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

  12. Cognitive function

    Time frame: Baseline, 3 months

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

  13. Cognitive function

    Time frame: Baseline, 3 months

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

  14. Cognitive function

    Time frame: Baseline, 3 months

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

  15. Cognitive function

    Time frame: Baseline, 3 months

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

  16. Cognitive function

    Time frame: Baseline, 3 months

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

  17. Occupational performance

    Time frame: Baseline, 3 months

    The Canadian Occupational Performance Measure (COPM)

  18. Experiences of the intervention and effects

    Time frame: 3 months

    Individual interviews with participants in the intervention group

Secondary outcomes

  1. Fear of falling

    Time frame: Baseline, 3 months

    The Falls Self-Efficacy Scale (FES-I)

  2. Psychological wellbeing

    Time frame: Baseline, 3 months

    The Philadelphia Geriatric Center Morale Scale (PGCMS)

  3. Physical activity

    Time frame: Baseline, 3 months

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

  4. Depressive disorders

    Time frame: Baseline, 3 months

    The Geriatric Depression Scale (GDS-15)

  5. Health related quality of life

    Time frame: Baseline, 3 months

    The EQ5D, Selected questions from The short form (36) Health survey

  6. Activities of daily life (ADL)

    Time frame: Baseline, 3 months

    The Katz ADL Index

  7. Descriptive information

    Time frame: Baseline

    Age, gender, education, living conditions, past and current medical conditions and medications from self-reported questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Annika Toots, PhD

CONTACT

[email protected]

0046 90 7866329

Magdalena Eriksson Domellöf, PhD

CONTACT

[email protected]

0046 90 7867022

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Collaborators

  • Region Västerbotten

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 14, 2025
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.