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Recruiting NCT05946109

Effect of an Exercise Program for Frail Older Adults

Trial Parameters

Condition Frailty
Sponsor Universitair Ziekenhuis Brussel
Study Type INTERVENTIONAL
Phase N/A
Enrollment 195
Sex ALL
Min Age 70 Years
Max Age N/A
Start Date 2023-07-04
Completion 2026-11-30
Interventions
ACTIVE-AGE@home

Brief Summary

Despite the high level of evidence for physical activity as a countermeasure for frailty, the current Flemish standard of care does not include structural PA interventions for community-dwelling frail older adults. One barrier for this, is the high cost of supervised physical activity programmes. Therefore, in this pragmatic randomised controlled trial, the investigators will consider the Flemish current standard of care for frail older adults as a control group. Intervention condition 1 reflects the state-of-the-art physical activity intervention provided by professionals and intervention condition 2 consists of the same intervention provided by trained volunteers. It is hypothesized that the intervention in both intervention conditions will have significant effects on functional ability, cognition, loneliness, self-management, subjective health and meaningful activities and that it can alleviate the financial burden of condition 1 (cost-effectiveness). The pretrajectory of this study was based on the 'British Medical Research Council guidance' for the development and evaluation of complex interventions. This resulted in a comprehensive, state-of-the art personalised physical activity programme for community-dwelling frail older adults: ACTIVE-AGE@home. The programme adheres to current guidelines for physical activity and exercise for frail older adults and considers low threshold and meaningful activities for the participants. The latter perfectly aligns with the complex bio-psychosocial components of frailty. Positive results will help reduce negative outcomes of frailty in older adults and will also reduce health and social expenditures. This study aligns with a 'prevention and health promotion' model.

Eligibility Criteria

Inclusion Criteria: * \>70 years adults * Frail according to the frailty phenotype of Fried, defining frailty as the presence of 3 or more of the following 5 criteria: unintentional weight loss, weakness, exhaustion (low energy level), slowness (slow gait) and low physical activity Exclusion Criteria: life expectancy less than 12 months by any cause * oncologic participants with active treatment * treatment with exercise therapy in the preceding 6 months * any contra-indication for exercise therapy as established by the treating physician/family practitioner * cognitive impairment (unable to understand the test instructions and/or Mini Mental State Examination score \<23/30) * unable to understand the Dutch language * diagnosed with Parkinson or Multiple Sclerosis * having had a stroke in the preceding 6 months" to the registry

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