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

Not Applicable

Completed

• Conditions: Sarcopenia; Frailty
• Interventions: Other: Exercise and protein

• Registration Number: NCT04628754
• Lead Sponsor: University College Dublin

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-09
• Study First Submitted QC: 2020-11-09
• Study First Posted: 2020-11-13
• Study Start: 2020-12-01
• Primary Completion: 2021-07-11
• Study Completion: 2021-07-11
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-03
• Last Update Posted: 2021-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 169

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Exercise and protein	Resistance exercise and dietary protein guidance

Primary Outcome Measures

Name	Time	Method
Frailty status	3 months	Frailty status as measured by SHARE-frailty instrument measurement

Secondary Outcome Measures

Name	Time	Method
Sarcopenia/ muscle mass	3 months	Sarcopenia/ muscle mass measured by bioelectrical impedance
Clinical frailty status	3 months	Clinical frailty status measured by Clinical Frailty Scale 1 to 9, 9 is worse
Ease of the intervention	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'
Bone mass	3 months	Bone mass measured by bioelectrical impedance
Subjective difference to general health	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'
Body fat	3 months	measured by bioelectrical impedance
Biological age	3 months	measured by bioelectrical impedance

Trial Locations

Locations (1)

Beechlawn Medical Centre; 🇮🇪 Dublin, Ireland