A Randomized Control Trial of an Intervention to Reverse Frailty and Enhance Resilience Through Exercise and Education (REFEREE)
Primary Purpose
Frailty, Sarcopenia
Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Exercise and protein
Sponsored by
About this trial
This is an interventional prevention trial for Frailty focused on measuring Resilience, Primary-care, Intervention, Exercise, Protein, Diet, Community
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
Sites / Locations
- Beechlawn Medical Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Resistance exercise and dietary protein guidance
Usual care
Outcomes
Primary Outcome Measures
Frailty status
Frailty status as measured by SHARE-frailty instrument measurement
Secondary Outcome Measures
Clinical frailty status
Clinical frailty status measured by Clinical Frailty Scale 1 to 9, 9 is worse
Sarcopenia/ muscle mass
Sarcopenia/ muscle mass measured by bioelectrical impedance
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'
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'
Bone mass
Bone mass measured by bioelectrical impedance
Body fat
measured by bioelectrical impedance
Biological age
measured by bioelectrical impedance
Full Information
NCT ID
NCT04628754
First Posted
November 9, 2020
Last Updated
December 3, 2021
Sponsor
University College Dublin
1. Study Identification
Unique Protocol Identification Number
NCT04628754
Brief Title
A Randomized Control Trial of an Intervention to Reverse Frailty and Enhance Resilience Through Exercise and Education
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
July 11, 2021 (Actual)
Study Completion Date
July 11, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University College Dublin
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty, Sarcopenia
Keywords
Resilience, Primary-care, Intervention, Exercise, Protein, Diet, Community
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
169 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Resistance exercise and dietary protein guidance
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Other
Intervention Name(s)
Exercise and protein
Intervention Description
Home based exercise regime and dietary protein guidance
Primary Outcome Measure Information:
Title
Frailty status
Description
Frailty status as measured by SHARE-frailty instrument measurement
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Clinical frailty status
Description
Clinical frailty status measured by Clinical Frailty Scale 1 to 9, 9 is worse
Time Frame
3 months
Title
Sarcopenia/ muscle mass
Description
Sarcopenia/ muscle mass measured by bioelectrical impedance
Time Frame
3 months
Title
Ease of the intervention
Description
Ease of the intervention measured on a five-point scale: 'very easy', 'somewhat easy', 'neither easy nor hard', 'somewhat hard', or 'very hard'
Time Frame
3 months
Title
Subjective difference to general health
Description
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'
Time Frame
3 months
Title
Bone mass
Description
Bone mass measured by bioelectrical impedance
Time Frame
3 months
Title
Body fat
Description
measured by bioelectrical impedance
Time Frame
3 months
Title
Biological age
Description
measured by bioelectrical impedance
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie Therese Cooney, PhD
Organizational Affiliation
University College Dublin
Official's Role
Study Director
Facility Information:
Facility Name
Beechlawn Medical Centre
City
Dublin
ZIP/Postal Code
0
Country
Ireland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33977224
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.
Results Reference
derived
Links:
URL
https://hrbopenresearch.org/articles/3-91
Description
Published protocol for this trial
Learn more about this trial
A Randomized Control Trial of an Intervention to Reverse Frailty and Enhance Resilience Through Exercise and Education
We'll reach out to this number within 24 hrs