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

University College Dublin

Status

Completed

Conditions

Frailty

Sarcopenia

Treatments

Other: Exercise and protein

Study type

Interventional

Funder types

Other

Identifiers

NCT04628754

REFEREE

Details and patient eligibility

About

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.

Enrollment

169 patients

Sex

All

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

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