A Randomized Control Trial of an Intervention to Reverse Frailty and Enhance Resilience Through Exercise and Education
NCT ID: NCT04628754
Last Updated: 2021-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
169 participants
INTERVENTIONAL
2020-12-01
2021-07-11
Brief Summary
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This study provides an opportunity to assess the effectiveness of an optimised intervention with community-dwelling adults aged 65 and over, whose baseline clinical frailty score is not worse than mild (i.e. 5 or less), evaluate improvements in health outcomes and demonstrate how the intervention may be incorporated efficiently in clinical practice. The results are intended to encourage mainstream adoption of practical interventions to reverse clinical frailty and build resilience in primary care.
An intervention with ten recommended resistance exercises and dietary guidance on protein consumption has been derived from findings of our systematic review and meta-analysis and optimised through a patient and public involvement (PPI) process and feasibility study.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Intervention
Resistance exercise and dietary protein guidance
Exercise and protein
Home based exercise regime and dietary protein guidance
Control
Usual care
No interventions assigned to this group
Interventions
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Exercise and protein
Home based exercise regime and dietary protein guidance
Eligibility Criteria
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Inclusion Criteria
* Rockwood clinical frailty scale score 4 or 5 (vulnerable or mildly frail)
* Able and willing to provide informed consent and to comply with the requirements of this study protocol
Exclusion Criteria
* End of life care
* Persons in residential care home
* Concurrent malignancy CKD stage 3 or 4
* Coded diagnosis of severe dementia as per GP or consultant geriatrician diagnosis or baseline Montreal Cognitive assessment (MoCA) score \<= 10
* Persons unable to engage in discussion on frailty due to acute care needs or determined to be inappropriate by GP (e.g., needing transfer to ED or acutely unwell or disorders resulting in intolerance of the intervention)
* Subjects unable to provide written informed consent
65 Years
ALL
Yes
Sponsors
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University College Dublin
OTHER
Responsible Party
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John Travers
Doctor
Principal Investigators
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Marie Therese Cooney, PhD
Role: STUDY_DIRECTOR
University College Dublin
Locations
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Beechlawn Medical Centre
Dublin, , Ireland
Countries
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References
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Travers J, Romero-Ortuno R, Power D, Doran P, Langan J, MacNamara F, McCormack D, McDermott C, McEntire J, McKiernan J, Vencken S, Murphy AW, Murphy PJ, Ni She E, O'Shea D, Cooney MT. Protocol for a randomised controlled trial of a primary care intervention to Reverse Frailty and Enhance Resilience through Exercise and dietary protein Education (REFEREE) in community-dwelling adults aged 65 and over. HRB Open Res. 2021 Apr 21;3:91. doi: 10.12688/hrbopenres.13188.2. eCollection 2020.
Related Links
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Published protocol for this trial
Other Identifiers
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REFEREE
Identifier Type: -
Identifier Source: org_study_id