FrailtyREFEREENCT04628754
A Randomized Control Trial of an Intervention to Reverse Frailty and Enhance Resilience Through Exercise and Education
A study testing Exercise and protein in people with Frailty and Sarcopenia, run by University College Dublin at 1 site in Ireland.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frailty, Sarcopenia
- What is being tested?
- Exercise and protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 1 siteIreland
- Study dates
- 1 Dec 2020to 11 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Frailty, Sarcopenia
- Being tested
- Exercise and protein
- Keywords
- Resilience, Primary-care, Intervention, Exercise, Protein, Diet, Community
- Medical subject headings
- Frailty, Sarcopenia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise and proteinOther
Home based exercise regime and dietary protein guidance
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Resistance exercise and dietary protein guidance Receives: Other: Exercise and protein |
| Control | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frailty status
Frailty status as measured by SHARE-frailty instrument measurement
Measured: 3 months
Secondary outcomes (7)
Clinical frailty status
Clinical frailty status measured by Clinical Frailty Scale 1 to 9, 9 is worse
Measured: 3 months
Sarcopenia/ muscle mass
Sarcopenia/ muscle mass measured by bioelectrical impedance
Measured: 3 months
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'
Measured: 3 months
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'
Measured: 3 months
Bone mass
Bone mass measured by bioelectrical impedance
Measured: 3 months
Body fat
measured by bioelectrical impedance
Measured: 3 months
Biological age
measured by bioelectrical impedance
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start1 Dec 2020
- Primary completion11 Jul 2021
- Study completion11 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Travers, University College Dublin
- Investigators
- Marie Therese Cooney, PhD, Study director, University College Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04628754
- Sponsor's protocol ID
- REFEREE
- Acronym
- REFEREE
- Status last verified
- Dec 2021
- First submitted
- 9 Nov 2020
- Last updated
- 17 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33977224
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04628754
- Acronym / sponsor ID
- REFEREE / REFEREE
- Conditions
- Frailty, Sarcopenia
- Keywords
- Resilience, Primary-care, Intervention, Exercise, Protein, Diet, Community
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 11 Jul 2021 (actual)
- Study completion
- 11 Jul 2021 (actual)
- First posted
- 13 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Exercise and proteinResistance exercise and dietary protein guidance |
| Control | No intervention | –Usual care |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise and proteinHome based exercise regime and dietary protein guidance | Other | Intervention |
Primary outcome
Frailty status
Time frame: 3 months
Frailty status as measured by SHARE-frailty instrument measurement
7 secondary outcomes
Clinical frailty status
Time frame: 3 months
Sarcopenia/ muscle mass
Time frame: 3 months
Ease of the intervention
Time frame: 3 months
Subjective difference to general health
Time frame: 3 months
Bone mass
Time frame: 3 months
Body fat
Time frame: 3 months
Biological age
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
- Derived from this study: PubMed 33977224Travers 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie Therese Cooney, PhD study director
University College Dublin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and protein in people with Frailty and Sarcopenia, run by University College Dublin at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frailty status (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04628754, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2021.