NCT05946109 Effect of an Exercise Program for Frail Older Adults
| NCT ID | NCT05946109 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitair Ziekenhuis Brussel |
| Condition | Frailty |
| Study Type | INTERVENTIONAL |
| Enrollment | 195 participants |
| Start Date | 2023-07-04 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 195 participants in total. It began in 2023-07-04 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Patricia De Vriendt, Prof dr
PRINCIPAL INVESTIGATOR
VUB
Frequently Asked Questions
Who can join the NCT05946109 clinical trial?
This trial is open to participants of all sexes, aged 70 Years or older, studying Frailty. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05946109 currently recruiting?
Yes, NCT05946109 is actively recruiting participants. Contact the research team at patricia.de.vriendt@vub.be for enrollment information.
Where is the NCT05946109 trial being conducted?
This trial is being conducted at Brussels, Belgium.
Who is sponsoring the NCT05946109 clinical trial?
NCT05946109 is sponsored by Universitair Ziekenhuis Brussel. The principal investigator is Patricia De Vriendt, Prof dr at VUB. The trial plans to enroll 195 participants.