A Randomized Control Trial of an Intervention to Reverse Frailty and Enhance Resilience Through Exercise and Education (REFEREE)
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Dublin, Irland
- Beechlawn Medical Centre
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: Styre
Vanlig omsorg
|
|
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Eksperimentell: Intervention
Resistance exercise and dietary protein guidance
|
Home based exercise regime and dietary protein guidance
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Frailty status
Tidsramme: 3 months
|
Frailty status as measured by SHARE-frailty instrument measurement
|
3 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Clinical frailty status
Tidsramme: 3 months
|
Clinical frailty status measured by Clinical Frailty Scale 1 to 9, 9 is worse
|
3 months
|
|
Sarcopenia/ muscle mass
Tidsramme: 3 months
|
Sarcopenia/ muscle mass measured by bioelectrical impedance
|
3 months
|
|
Ease of the intervention
Tidsramme: 3 months
|
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
|
|
Subjective difference to general health
Tidsramme: 3 months
|
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
|
|
Bone mass
Tidsramme: 3 months
|
Bone mass measured by bioelectrical impedance
|
3 months
|
|
Body fat
Tidsramme: 3 months
|
measured by bioelectrical impedance
|
3 months
|
|
Biological age
Tidsramme: 3 months
|
measured by bioelectrical impedance
|
3 months
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Marie Therese Cooney, PhD, University College Dublin
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- REFEREE
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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