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

Sarcopenia Clinical Trial

— REFEREE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04628754
• Other study ID #: REFEREE
• Status: Completed
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: July 11, 2021

Study information

• Verified date: December 2021
• Source: University College Dublin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: July 11, 2021
• Est. primary completion date: July 11, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Frailty
• Sarcopenia

Intervention

Other:
• Exercise and protein
Home based exercise regime and dietary protein guidance

Locations

Country	Name	City	State
Ireland	Beechlawn Medical Centre	Dublin

Sponsors (1)

Lead Sponsor	Collaborator
University College Dublin

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frailty status	Frailty status as measured by SHARE-frailty instrument measurement	3 months
Secondary	Clinical frailty status	Clinical frailty status measured by Clinical Frailty Scale 1 to 9, 9 is worse	3 months
Secondary	Sarcopenia/ muscle mass	Sarcopenia/ muscle mass measured by bioelectrical impedance	3 months
Secondary	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
Secondary	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
Secondary	Bone mass	Bone mass measured by bioelectrical impedance	3 months
Secondary	Body fat	measured by bioelectrical impedance	3 months
Secondary	Biological age	measured by bioelectrical impedance	3 months

External Links

•   Published protocol for this trial