---
title: A Randomized Control Trial of an Intervention to Reverse Frailty and Enhance Resilience Through Exercise and Education
nct_id: NCT04628754
overall_status: COMPLETED
phase: NA
sponsor: University College Dublin
study_type: INTERVENTIONAL
primary_condition: Frailty
countries: Ireland
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04628754.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04628754"
ct_last_update_post_date: 2021-12-17
last_seen_at: "2026-05-12T06:21:15.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Randomized Control Trial of an Intervention to Reverse Frailty and Enhance Resilience Through Exercise and Education

**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

**NCT ID:** [NCT04628754](https://clinicaltrials.gov/study/NCT04628754)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 169
- **Lead Sponsor:** University College Dublin
- **Conditions:** Frailty, Sarcopenia
- **Start Date:** 2020-12-01
- **Completion Date:** 2021-07-11
- **CT.gov Last Update:** 2021-12-17

## 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.

## Eligibility

- **Minimum age:** 65 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
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
```

## Arms

- **Intervention** (EXPERIMENTAL) — Resistance exercise and dietary protein guidance
- **Control** (NO_INTERVENTION) — Usual care

## Interventions

- **Exercise and protein** (OTHER) — Home based exercise regime and dietary protein guidance

## Primary Outcomes

- **Frailty status** _(time frame: 3 months)_ — Frailty status as measured by SHARE-frailty instrument measurement

## 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)_

## Locations (1)

- Beechlawn Medical Centre, Dublin, Ireland

## Recent Field Changes (last 30 days)

- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.beechlawn medical centre|dublin||ireland` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04628754.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04628754*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*