A Randomized Control Trial of an Intervention to Reverse Frailty and Enhance Resilience Through Exercise and Education

Study Overview
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Brief Summary
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Resistance training done at home and protein supplementation may be the most effective and easiest to implement interventions to reverse frailty and build resilience. However, it is not common practice to offer and support such interventions in primary care. 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.

Official Title
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A Randomized Control Trial of a Primary Care Intervention to Reverse Frailty and Enhance Resilience Through Resistance Exercise and Dietary Protein Education (REFEREE) Among Community Dwelling Adults Aged 65 and Over

Conditions
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Frailty, Sarcopenia

Intervention / Treatment
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* Other: Exercise and protein


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 65 or older at baseline 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: Rockwood clinical frailty scale score > 5 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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Resistance exercise and dietary protein guidance | Other: Exercise and protein<br>* Home based exercise regime and dietary protein guidance<br>|
| No Intervention: Control<br>Usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frailty status | Frailty status as measured by SHARE-frailty instrument measurement | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical frailty status | Clinical frailty status measured by Clinical Frailty Scale 1 to 9, 9 is worse | 3 months | 
| Sarcopenia/ muscle mass | Sarcopenia/ muscle mass measured by bioelectrical impedance | 3 months | 
| Ease of the intervention | Ease of the intervention measured on a five-point scale: 'very easy', 'somewhat easy', 'neither easy nor hard', 'somewhat hard', or 'very hard' | 3 months | 
| Subjective difference to general health | Difference to general health as a result of the exercises measured on a five-point scale: 'much better', 'slightly better', 'about the same', 'slightly worse' or 'much worse' | 3 months | 
| Bone mass | Bone mass measured by bioelectrical impedance | 3 months | 
| Body fat | measured by bioelectrical impedance | 3 months | 
| Biological age | measured by bioelectrical impedance | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Community, Resilience, Primary-care, Intervention, Exercise, Protein, Diet