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

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.

Study Overview

• Status: Recruiting
• Conditions: Gait; Cognition; Accidental Falls; Postural Balance
• Intervention / Treatment: Other: HIFE+cog; Other: HIFE

• Study Type: Interventional
• Enrollment (Estimated): 33
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Annika Toots, PhD; Phone Number: 0046 90 7866329; Email: annika.toots@umu.se
• Study Contact Backup: Name: Magdalena Eriksson Domellöf, PhD; Phone Number: 0046 90 7867022; Email: magdalena.domellof@umu.se

Study Locations

• Sweden
  • Umeå, Sweden, 90187
    • Recruiting
    • Umeå University
    • Contact: Annika Toots, PhD; Phone Number: 0046907866329; Email: annika.toots@umu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: High-intensity functional exercise (HIFE); High intensity functional exercise (HIFE) program, individually tailored and performed twice weekly for 12 weeks, in supervised groups.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fear of falling	The Falls Self-Efficacy Scale (FES-I)	Baseline, 3 months
Psychological wellbeing	The Philadelphia Geriatric Center Morale Scale (PGCMS)	Baseline, 3 months
Physical activity	The International Physical Activity Questionnaire-Elderly (IPAQ-E)	Baseline, 3 months
Depressive disorders	The Geriatric Depression Scale (GDS-15)	Baseline, 3 months
Health related quality of life	The EQ5D, Selected questions from The short form (36) Health survey	Baseline, 3 months
Activities of daily life (ADL)	The Katz ADL Index	Baseline, 3 months
Descriptive information	Age, gender, education, living conditions, past and current medical conditions and medications from self-reported questionnaire	Baseline

Collaborators and Investigators

• Sponsor: Umeå University
• Collaborators: Region Västerbotten
• Investigators: Principal Investigator: Annika Toots, PhD, Umeå University

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2025
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: January 7, 2025
• First Submitted That Met QC Criteria: January 11, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 21, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Gait; Cognition; Aged; Exercise therapy; Resistance training; Postural balance; Accidental falls
• Other Study ID Numbers: Dnr 2024-07683-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The datasets generated and analysed during the study will not publicly available to protect the participants' confidentiality (in accordance with The General Data Protection Regulation, European Union Regulation) but are available from the principal investigator on reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No