NCT04628754

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
169

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 13, 2020

Completed
18 days until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 11, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2021

Completed
Last Updated

December 17, 2021

Status Verified

December 1, 2021

Enrollment Period

7 months

First QC Date

November 9, 2020

Last Update Submit

December 3, 2021

Conditions

FrailtySarcopenia

Keywords

ResiliencePrimary-careInterventionExerciseProteinDietCommunity

Outcome Measures

Primary Outcomes (1)

  • Frailty status

    Frailty status as measured by SHARE-frailty instrument measurement

    3 months

Secondary Outcomes (7)

  • Clinical frailty status

    3 months

  • Sarcopenia/ muscle mass

    3 months

  • Ease of the intervention

    3 months

  • Subjective difference to general health

    3 months

  • Bone mass

    3 months

  • +2 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Resistance exercise and dietary protein guidance

Other: Exercise and protein

Control

NO INTERVENTION

Usual care

Interventions

Exercise and proteinOTHER

Home based exercise regime and dietary protein guidance

Intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beechlawn Medical Centre

Dublin, 0, Ireland

Location

Related Publications (1)

  • 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.

    PMID: 33977224DERIVED

Related Links

MeSH Terms

Conditions

FrailtySarcopeniaMotor Activity

Interventions

ExerciseProteins

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalSigns and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaAmino Acids, Peptides, and Proteins

Study Officials

  • Marie Therese Cooney, PhD

    University College Dublin

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

November 9, 2020

First Posted

November 13, 2020

Study Start

December 1, 2020

Primary Completion

July 11, 2021

Study Completion

July 11, 2021

Last Updated

December 17, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

IE(1)