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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04628754
Acronym
REFEREE
Enrollment
169
Registered
2020-11-13
Start date
2020-12-01
Completion date
2021-07-11
Last updated
2021-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frailty, Sarcopenia

Keywords

Resilience, Primary-care, Intervention, Exercise, Protein, Diet, Community

Brief summary

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.

Interventions

OTHERExercise and protein

Home based exercise regime and dietary protein guidance

Sponsors

University College Dublin
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Frailty status3 monthsFrailty status as measured by SHARE-frailty instrument measurement

Secondary

MeasureTime frameDescription
Sarcopenia/ muscle mass3 monthsSarcopenia/ muscle mass measured by bioelectrical impedance
Ease of the intervention3 monthsEase of the intervention measured on a five-point scale: 'very easy', 'somewhat easy', 'neither easy nor hard', 'somewhat hard', or 'very hard'
Subjective difference to general health3 monthsDifference 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'
Clinical frailty status3 monthsClinical frailty status measured by Clinical Frailty Scale 1 to 9, 9 is worse
Body fat3 monthsmeasured by bioelectrical impedance
Biological age3 monthsmeasured by bioelectrical impedance
Bone mass3 monthsBone mass measured by bioelectrical impedance

Countries

Ireland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026