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A multimodal intervention program for older people with frailty – a randomized controlled pilot trial

A multimodal intervention program for older people with frailty – a randomized controlled pilot trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00011831
Enrollment
50
Registered
2017-05-17
Start date
2017-05-19
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frailty in older people R54

Interventions

Group 1: Participants of the intervention group receive usual care plus a multimodal intervention. The multimodal intervention includes a home-based physical exercise program (HIFE program), a multimo

Sponsors

Hochschule für Gesundheit, Bochum
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: Community-dwelling people with frailty (Frailty Index = 0.25).

Exclusion criteria

Exclusion criteria: [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 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)

Design outcomes

Primary

MeasureTime frame
Feasibility: Process aspects, resource aspects, management aspects, scientific aspects (Thabane 2010) 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).

Secondary

MeasureTime frame
Effectiveness: The secondary outcomes are assessed after the intervention period and at follow-up. [1] Physical frailty (Physical Frailty Phenotype) [2] Cognition (Minimal Mental State Examination) [3] Mobility (De Morton Mobility Index) [4] Ambulation (Functional Ambulation Categories ) [5] Mobility/fall risk (Timed Up And Go Test) [6] Gait speed (4m gait speed test) [7] Physical functioning (Short Physical Performance Battery) [8] Fear of falling (Falls Efficacy Scale International) [9] Health-related quality of life (SF-12) [10] Depression/mood (Geriatric Depression Scale) [11] Disability (Late Life Function Index) [12] Participation (Late Life Disability Index [13] Multimorbidity (Charlson Comorbidity Index) [14] Nutritional state (Mini Nutritional Assessment) [15] Physical activity (accelerometry) [16] Falls (falls diary) [17] Hospital admissions (self-report of participants)

Countries

Germany

Contacts

Public ContactTobias Braun

Hochschule für Gesundheit, Bochum

tobias.braun@hs-gesundheit.de0234 77727 625

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 23, 2026