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| Name | Class |
|---|---|
| Region Västerbotten | OTHER_GOV |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Annika Toots, PhD | Contact | 0046 90 7866329 | annika.toots@umu.se | |
| Magdalena Eriksson Domellöf, PhD | Contact | 0046 90 7867022 | magdalena.domellof@umu.se |
| Name | Affiliation | Role |
|---|---|---|
| Annika Toots, PhD | Umeå University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Umeå University | Recruiting | Umeå | 90187 | Sweden |
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.
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Outcome assessors will be blinded to group allocation. Participants will receive repeated instructions not to disclose their group allocation to the assessors.
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| 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. |
|
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 |
| 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 |