A multimodal intervention program for older people with frailty – a randomized controlled pilot trial
- Conditions
- Frailty in older peopleR54Senility
- Registration Number
- DRKS00011831
- Lead Sponsor
- Hochschule für Gesundheit, Bochum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 41
Community-dwelling people with frailty (Frailty Index = 0.25).
[1] blindness/severe visual impairment
[2] deafness/severe hearing impairment
[3] language barrier (German)
[4] inability to understand/comply the study information and to give informed consent (e.g. severe aphasia, severe cognitive impairment/dementia)
[5] infection / acute illness
[6] scheduling issues (e.g. planed absence such as holidays, rehabilitation/hospital stay within the study period with a duration of >14 days in a row)
[7] life expectancy of <12 months
[8] not living in the city of Bochum
[9] currently or planed participation in another regular sport or exercise training (>1x/week)
[10] any medical restriction for an individually tailored exercise training:
[10a] one of the following severe cardio-vascular diseases: unstable angina pectoris; decompensated congestive heart failure; unstable blood pressure; heart attack with the last 3 months
[10b] Complex fractures or orthopedic surgery with complications and/or persisting severe complaints within the last 3 months; severe joint disorders.
[10c] Severe neurological diseases which would prevent participation in the exercise program, such as severe Parkinsons’s disease (Hoehn & Yahr >3), stroke with severe hemiparesis (National Institutes of Health Stroke Scale >6)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Feasibility: Process aspects, resource aspects, management aspects, scientific aspects (Thabane 2010)<br><br>Effectiveness: Between-group difference in the number of people with frailty (assessed by the Frailty Index Searle et al. 2008) after the intervention (after 3 months) and at follow-up (after further 3 months).<br>
- Secondary Outcome Measures
Name Time Method Effectiveness: The secondary outcomes are assessed after the intervention period and at follow-up.<br><br>[1] Physical frailty (Physical Frailty Phenotype)<br>[2] Cognition (Minimal Mental State Examination)<br>[3] Mobility (De Morton Mobility Index)<br>[4] Ambulation (Functional Ambulation Categories )<br>[5] Mobility/fall risk (Timed Up And Go Test)<br>[6] Gait speed (4m gait speed test)<br>[7] Physical functioning (Short Physical Performance Battery)<br>[8] Fear of falling (Falls Efficacy Scale International)<br>[9] Health-related quality of life (SF-12)<br>[10] Depression/mood (Geriatric Depression Scale)<br>[11] Disability (Late Life Function Index)<br>[12] Participation (Late Life Disability Index<br>[13] Multimorbidity (Charlson Comorbidity Index)<br>[14] Nutritional state (Mini Nutritional Assessment)<br>[15] Physical activity (accelerometry)<br>[16] Falls (falls diary)<br>[17] Hospital admissions (self-report of participants)<br>