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Completed

NCT Number: NCT04628754

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

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.

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Key information

Conditions

Frailty Atrophy Behavior Motor Activity Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beechlawn Medical Centre

Dublin, Ireland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise and protein

Other

Home based exercise regime and dietary protein guidance

Primary outcomes

  1. Frailty status

    Time frame: 3 months

    Frailty status as measured by SHARE-frailty instrument measurement

Secondary outcomes

  1. Clinical frailty status

    Time frame: 3 months

    Clinical frailty status measured by Clinical Frailty Scale 1 to 9, 9 is worse

  2. Sarcopenia/ muscle mass

    Time frame: 3 months

    Sarcopenia/ muscle mass measured by bioelectrical impedance

  3. Ease of the intervention

    Time frame: 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'

  4. Subjective difference to general health

    Time frame: 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'

  5. Bone mass

    Time frame: 3 months

    Bone mass measured by bioelectrical impedance

  6. Body fat

    Time frame: 3 months

    measured by bioelectrical impedance

  7. Biological age

    Time frame: 3 months

    measured by bioelectrical impedance

Sponsors and collaborators

Lead sponsor

University College Dublin

Other

Registry information

Official study 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

Acronym: REFEREE

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 13, 2020
Registry last updated
Dec 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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