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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
33
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.
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.
Umeå University
Umeå, Sweden
RECRUITINGRecruitment
Rate of recruited participants, and sources for recruitment
Time frame: Before intervention start
Adherence
Number of exercise sessions attended
Time frame: 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
Time frame: Through the 3-month intervention
Retention
Number of participants that completed follow-ups
Time frame: 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
Time frame: Through the 3-month intervention period
Balance and gait capacity
The Timed up and go (TUG) test, with and without cognitive task
Time frame: Baseline, 3 months
Balance and gait capacity
The 4m forward gait speed test, with and without cognitive task
Time frame: Baseline, 3 months
Balance and gait capacity
The 4m backward gait speed test
Time frame: Baseline, 3 months
Balance and gait capacity
The Berg balance scale
Time frame: Baseline, 3 months
Balance and gait capacity
The 30-s Chair stand test
Time frame: Baseline, 3 months
Cognitive function
The Mindmore cognitive battery: Mental speed with The Symbol-Digit Processing test
Time frame: Baseline, 3 months
Cognitive function
The Mindmore cognitive battery: Mental speed with The Reaction test I and II
Time frame: Baseline, 3 months
Cognitive function
The Mindmore cognitive battery: Attention and executive function (shifting) with The Trail making test - Click (TMT-Click)
Time frame: Baseline, 3 months
Cognitive function
The Mindmore cognitive battery: Short term- and working memory with The Corsi Block test
Time frame: Baseline, 3 months
Cognitive function
The Mindmore cognitive battery: Executive function (inhibition) with The Stroop test
Time frame: Baseline, 3 months
Cognitive function
The Mindmore cognitive battery: Executive function (verbal fluency) with The FAS test
Time frame: Baseline, 3 months
Occupational performance
The Canadian Occupational Performance Measure (COPM)
Time frame: Baseline, 3 months
Experiences of the intervention and effects
Individual interviews with participants in the intervention group
Time frame: 3 months
Fear of falling
The Falls Self-Efficacy Scale (FES-I)
Time frame: Baseline, 3 months
Psychological wellbeing
The Philadelphia Geriatric Center Morale Scale (PGCMS)
Time frame: Baseline, 3 months
Physical activity
The International Physical Activity Questionnaire-Elderly (IPAQ-E)
Time frame: Baseline, 3 months
Depressive disorders
The Geriatric Depression Scale (GDS-15)
Time frame: Baseline, 3 months
Health related quality of life
The EQ5D, Selected questions from The short form (36) Health survey
Time frame: Baseline, 3 months
Activities of daily life (ADL)
The Katz ADL Index
Time frame: Baseline, 3 months
Descriptive information
Age, gender, education, living conditions, past and current medical conditions and medications from self-reported questionnaire
Time frame: Baseline
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.