Clinical trial NCT04628754: A Randomized Control Trial of an Intervention to Reverse Frailty and Enhance Resilience Through Exercise and Education
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frailty
Sarcopenia
Keywords: Resilience
Primary-care
Intervention
Exercise
Protein
Diet
Community
Lead sponsor: University College Dublin
Sponsor class: OTHER
First posted: 2020-11-13
Enrollment: 169
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Frailty status
timeFrame: 3 months
Secondary outcomes:
measure: Clinical frailty status
timeFrame: 3 months
measure: Sarcopenia/ muscle mass
timeFrame: 3 months
measure: Ease of the intervention
timeFrame: 3 months
measure: Subjective difference to general health
timeFrame: 3 months
measure: Bone mass
timeFrame: 3 months
measure: Body fat
timeFrame: 3 months
measure: Biological age
timeFrame: 3 months
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Beechlawn Medical Centre
Study officials:
affiliation: University College Dublin
name: Marie Therese Cooney, PhD
role: STUDY_DIRECTOR
References:
citation: 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.