Accidental Falls, Cognition, Gait, Postural Balance
Conditions
Keywords
Accidental falls, Postural balance, Gait, Cognition, Exercise therapy, Resistance training, Aged
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.
Interventions
OTHERHIFE+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.
OTHERHIFE
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.
Sponsors
Region Västerbotten
Umeå University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessors will be blinded to group allocation. Participants will receive repeated instructions not to disclose their group allocation to the assessors.
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Experiences of the intervention and effects | 3 months | Individual interviews with participants in the intervention group |
| Adherence | Through the 3-month intervention | Number of exercise sessions attended |
| Exercise intervention content and delivery | 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 |
| Retention | Through the 3-month intervention | Number of participants that completed follow-ups |
| Safety | 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 |
| Balance and gait capacity | Baseline, 3 months | The Timed up and go (TUG) test, with and without cognitive task |
| Cognitive function | Baseline, 3 months | The Mindmore cognitive battery: Mental speed with The Symbol-Digit Processing test |
| Occupational performance | Baseline, 3 months | The Canadian Occupational Performance Measure (COPM) |
| Recruitment | Before intervention start | Rate of recruited participants, and sources for recruitment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Descriptive information | Baseline | Age, gender, education, living conditions, past and current medical conditions and medications from self-reported questionnaire |
| Fear of falling | Baseline, 3 months | The Falls Self-Efficacy Scale (FES-I) |
| Psychological wellbeing | Baseline, 3 months | The Philadelphia Geriatric Center Morale Scale (PGCMS) |
| Physical activity | Baseline, 3 months | The International Physical Activity Questionnaire-Elderly (IPAQ-E) |
| Depressive disorders | Baseline, 3 months | The Geriatric Depression Scale (GDS-15) |
| Health related quality of life | Baseline, 3 months | The EQ5D, Selected questions from The short form (36) Health survey |
| Activities of daily life (ADL) | Baseline, 3 months | The Katz ADL Index |
Countries
Sweden
Contacts
Primary ContactAnnika Toots, PhD
Backup ContactMagdalena Eriksson Domellöf, PhD
Outcome results
None listed