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NCT05700305
Physical Rehabilitation Intervention With Protein Supplementation for People With Problematic Substance Use and Homelessness
trial testing 12-week, low threshold physical rehabilitation intervention with protein supplementation in Social Isolation in 45 participants. Completed in 10 March 2023.
5 December 2022
Quick facts
| Lead sponsor | University of Dublin, Trinity College |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 45 |
| Start date | 10 October 2022 |
| Primary completion | 5 December 2022 |
| Estimated completion | 10 March 2023 |
| Sites | 1 location across Ireland |
Drugs / interventions tested
- 12-week, low threshold physical rehabilitation intervention with protein supplementation
Conditions studied
- Social Isolation — all drugs for Social Isolation →
- Chronic Disease — all drugs for Chronic Disease →
- Physical Disability — all drugs for Physical Disability →
- Addiction — all drugs for Addiction →
Sponsor
University of Dublin, Trinity College
Who can join
18 and older, any sex, with Social Isolation or Chronic Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Background: People who are homeless are more likely to experience poor mental health and addiction as well as suffering from non-communicable diseases. There is evidence of frailty and accelerated physical ageing among people experiencing homelessness. Appropriate physical rehabilitation and nutritional supplementation strategies can stabilize or reverse frailty and general physical decline, but it is not known how this type of intervention would work in practice in this population. Aim: To evaluate the feasibility and preliminary efficacy of a physical rehabilitation drop in intervention with protein supplementation to target physical functioning and frailty in people with problematic substance use who are experiencing homelessness. Methods: The intervention will consist of a 12-week low threshold physical rehabilitation program with protein supplementation. Participants will be service users of the Advance Ballyfermot Project, a day services center for people who are homeless and have active addiction issues. Primary outcomes will be feasibility including numbers recruited, retention of participants and number of repeat visits. Any adverse events will be recorded. Secondary outcomes will be strength and muscular mass, physical performance and lower extremity physical function, pain, frailty and nutritional status.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Acceptability and utility of a broad test battery to evaluate physical functioning and frailty in community-based settings for people experiencing homelessness and addiction-Findings from the LEAP trials.
Kennedy F, Ní Cheallaigh C, Romero-Ortuno R, Murray D, et al · · 2025 · cited 2× · PMID 39626407 · DOI 10.1016/j.physio.2024.101449 -
Evaluation of a Low-threshold Exercise And Protein supplementation intervention for Women (LEAP-W) experiencing homelessness and addiction: Protocol for a single-arm mixed methods feasibility study.
Kennedy F, Murray D, Ní Cheallaigh C, Romero-Ortuno R, et al · · 2025 · cited 1× · PMID 39913349 · DOI 10.1371/journal.pone.0300412 -
Impact of a physiotherapy-led low threshold exercise and protein supplementation intervention to optimise physical function and target frailty in people experiencing homelessness and addiction: The LEAP-II trial.
Kennedy F, Cheallaigh CN, Romero-Ortuno R, Murray D, et al · · 2025 · PMID 41946023 · DOI 10.1016/j.physio.2025.101873
Verify or expand the search:
- PubMed search for NCT05700305
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05700305 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Dublin, Trinity College
- Last refreshed: 12 May 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05700305.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing