Social IsolationNCT05700305
Physical Rehabilitation Intervention With Protein Supplementation for People With Problematic Substance Use and Homelessness
An observational study of Social Isolation and Chronic Disease, run by University of Dublin, Trinity College at 1 site in Ireland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Social Isolation, Chronic Disease, Physical Disability
- What is being tested?
- 12-week, low threshold physical rehabilitation intervention with protein supplementation
- How many people
- 45 participants
- Where
- 1 siteIreland
- Study dates
- 10 Oct 2022to 10 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Clients accessing services in the Advance Ballyfermot Project (Dublin)
Who may be able to join
- Any person (>18 years) accessing services in Ballyfermot Advance
Who cannot join
- Any person with acute problematic behavioural issues, confusion or major physical problems
- Females with confirmed pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Feasibility Study to Explore the Role of Exercise and Nutrition to Target Frailty in People With Problematic Substance Use and Homelessness
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.
Read the detailed description
This single arm feasibility cohort study is taking place in the Advance Ballyfermot Project, located in Dublin. This centre provides a 5-day a week meal service as well as drug related services for people with active addiction issues who are temporarily housed or homeless. A dedicated exercise room has been allocated for the duration of the intervention period. This study has received ethical approval from the Faculty of Health Sciences REC at Trinity College Dublin (Ethical Approval Reference Number: 211202).
The aim of the study is to be as low threshold as possible. This means that minimal constraints are put in place to access the intervention. In order to be as pragmatic as possible in terms of inclusion criteria, all clients (>18 years) accessing services from The Advance Ballyfermot Project who consent to study participation can be included in this study. Only participants with acute problematic behavioral issues or confusion, are in an agitated state or have major physical problems ,(medical or orthopedic) which would preclude ability to safely participate in the exercise class will be excluded from study participation. Participants with a confirmed pregnancy will also be excluded.
The intervention will consist of a twice weekly (for 12 weeks, from November 2022 to February 2023) exercise class with nutritional intervention and a once weekly 'Park Walk'. The intervention will be fully supervised and delivered by two research physiotherapists.
Each session will commence with a warm-up and stretch of the major muscles and will end with cool-down and stretch. The intensity of the workout will be managed by using the Borg Perceived Rate of Exertion (RPE) scale where participants will be advised to exercise at a rate of between 11 and 13 on the PRE scale, ie. between 'fairly light' to 'somewhat hard', where they find it hard to have a conversation but can comfortably continue to exercise.
In an attempt to build sustainability beyond the life cycle of the project, participants will also be educated about exercise and available local resources where possible. Clients will be invited and encouraged to return weekly to continue with the exercise intervention.
The service provided will be low threshold to facilitate adherence and compliance. The research physiotherapists will make every effort to be flexible and accommodating to participants who do not need to make repeat appointments and may turn up on the day of the intervention. Adherence to the program will be measured by the uptake, compliance and number of repeat visits to the drop-in program. Demographic information will include biological sex and current homeless status.
Demographic details, including age, and named General Practitioner (GP) of participants will be collected. A letter will be sent to the GP to inform them of study participation. Questions around current addiction status will be guided by Section 1 of the Treatment Outcome Profile (TOP).
Analytic Plan Our study is very much feasibility focused and not hypothesis driven so formal power calculations are not directly applicable. Prospectively, potential participants that meet the study eligibility criteria will be invited to participate. Descriptive statistics will summarize participant demographics and feasibility measures such as attendance rates. Nominal or ordinal variables will be reported as frequencies and percentages. Continuous variables will be summarized as mean and standard deviation if normally distributed and median and inter-quartile range if non-normally distributed. Data will be tested for normality using the Kolmogorov-Smirnov test and will be compared across timepoints using the general linear model procedure (normally distributed data) and the Friedman's test (non-normally distributed data). As participants will be heterogeneous, data will be sub-stratified and participants will be grouped meaningfully. Free text responses from subjective questions will be reported and organized into topic areas.
- Conditions
- Social Isolation, Chronic Disease, Physical Disability, Addiction
- Being tested
- 12-week, low threshold physical rehabilitation intervention with protein supplementation
- Medical subject headings
- Social Isolation, Chronic Disease, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12-week, low threshold physical rehabilitation intervention with protein supplementationOther
Also called Physical rehabilitation intervention with protein supplementation
12 week, low threshold, rolling exercise intervention with protein supplementation
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
Number recruited to study
Measured: October to December 2022
Adverse events
Any injuries or incidence will be recorded
Measured: Through to study completion, up to 12 weeks
Adherence
Number of repeat visits
Measured: Through to study completion, up to 12 weeks
Secondary outcomes (13)
Hand-grip dynamometer
Strength will be measured using a hand-grip dynamometer
Measured: Baseline and 12 weeks
Limb circumference measurement
Measurement of sarcopenia via mid girth circumference measures of calf and upper arm
Measured: Baseline and 12 weeks
The Two Minute Walk Test
Measurement of walking ability and functional capacity
Measured: Baseline and 12 weeks
Numerical Rating Scale
A unidimensional measure of pain intensity from 0-10, with 0 being zero pain and 10 the worst pain imaginable.
Measured: Baseline and 12 weeks
Clinical Frailty Scale
Each point on the scale is correlated with a description of frailty and a visual chart to aid the tester in classifying frailty from 1 (very fit) to 9 (terminally ill). Higher scores indicate higher levels of frailty.
Measured: Baseline and 12 weeks
SHARE Frailty instrument
The SHARE-FI is a valid tool to measure the level of frailty in individuals aged over 50 years. It consists of quick questions related of the following variables; exhaustion, loss of appetite, walking difficulties and low physical activity. Answers are entered into a freely available web calculator to generate a frailty score and a frailty category of non-frail, pre-frail and frail is generated.
Measured: Baseline and 12 weeks
Mini-nutritional assessment
Assesses nutritional status. The maximum score is 14. A score of 12-14 indicates normal nutritional status; a score between 8 and 11 indicates risk of malnutrition and a score of 7 or less indicates malnourishment.
Measured: Baseline and 12 weeks
Body mass Index
Will be estimated using height (stadiometer) and weight (standardised digital scales)
Measured: Baseline and 12 weeks
Self-report open ended questions
Perceptions about health, physical status and exercise
Measured: Baseline and 12 weeks
The 10 Metre Walk Test
Measurement of walking speed
Measured: Baseline and 12 weeks
Single Leg Stance Test
Measurement of balance and postural control
Measured: Bseline and 12 weeks
The 30-Second Chair Stand Test
Measurement of lower limb strength and endurance
Measured: Baseline and 12 weeks
Short Form 12
A self-report measure of health used across age, disease and treatment groups. It uses eight domains including physical and social activities, pain, mental health, emotional health, vitality and general health perceptions to measure health. The participant completes a 12 question survey which is scored by the researcher. The minimum possible score is 12 and the maximum possible score is 48. Lower scores indicate better health.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start10 Oct 2022
- Primary completion5 Dec 2022
- Study completion10 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Social IsolationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dublin, Trinity College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie Broderick, University of Dublin, Trinity College
- Investigators
- Julie Broderick, Principal investigator, University of Dublin, Trinity College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05700305
- Sponsor's protocol ID
- Trinity College Dublin
- Status last verified
- May 2023
- First submitted
- 19 Jul 2022
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kennedy F, Cheallaigh CN, Romero-Ortuno R, Murray D, Broderick J. 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. Physiotherapy. 2026 Sep;132:101873. doi: 10.1016/j.physio.2025.101873. Epub 2025 Dec 20.
PubMed 41946023Kennedy F, Murray D, Ni Cheallaigh C, Romero-Ortuno R, Broderick J. 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. PLoS One. 2025 Feb 6;20(2):e0300412. doi: 10.1371/journal.pone.0300412. eCollection 2025.
PubMed 39913349Kennedy F, Ni Cheallaigh C, Romero-Ortuno R, Murray D, Broderick J. 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. Physiotherapy. 2025 Mar;126:101449. doi: 10.1016/j.physio.2024.101449. Epub 2024 Nov 7.
PubMed 39626407
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study to Explore the Role of Exercise and Nutrition to Target Frailty in People With Problematic Substance Use and Homelessness
- ClinicalTrials.gov ID
- NCT05700305
- Acronym / sponsor ID
- Trinity College Dublin
- Conditions
- Social Isolation, Chronic Disease, Physical Disability, Addiction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of Dublin, Trinity CollegeUniversity, hospital or other
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 5 Dec 2022 (actual)
- Study completion
- 10 Mar 2023 (actual)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This single arm feasibility cohort study is taking place in the Advance Ballyfermot Project, located in Dublin. This centre provides a 5-day a week meal service as well as drug related services for people with active addiction issues who are temporarily housed or homeless. A dedicated exercise room has been allocated for the duration of the intervention period. This study has received ethical approval from the Faculty of Health Sciences REC at Trinity College Dublin (Ethical Approval Reference Number: 211202).
The aim of the study is to be as low threshold as possible. This means that minimal constraints are put in place to access the intervention. In order to be as pragmatic as possible in terms of inclusion criteria, all clients (>18 years) accessing services from The Advance Ballyfermot Project who consent to study participation can be included in this study. Only participants with acute problematic behavioral issues or confusion, are in an agitated state or have major physical problems ,(medical or orthopedic) which would preclude ability to safely participate in the exercise class will be excluded from study participation. Participants with a confirmed pregnancy will also be excluded.
The intervention will consist of a twice weekly (for 12 weeks, from November 2022 to February 2023) exercise class with nutritional intervention and a once weekly 'Park Walk'. The intervention will be fully supervised and delivered by two research physiotherapists.
Each session will commence with a warm-up and stretch of the major muscles and will end with cool-down and stretch. The intensity of the workout will be managed by using the Borg Perceived Rate of Exertion (RPE) scale where participants will be advised to exercise at a rate of between 11 and 13 on the PRE scale, ie. between 'fairly light' to 'somewhat hard', where they find it hard to have a conversation but can comfortably continue to exercise.
In an attempt to build sustainability beyond the life cycle of the project, participants will also be educated about exercise and available local resources where possible. Clients will be invited and encouraged to return weekly to continue with the exercise intervention.
The service provided will be low threshold to facilitate adherence and compliance. The research physiotherapists will make every effort to be flexible and accommodating to participants who do not need to make repeat appointments and may turn up on the day of the intervention. Adherence to the program will be measured by the uptake, compliance and number of repeat visits to the drop-in program. Demographic information will include biological sex and current homeless status.
Demographic details, including age, and named General Practitioner (GP) of participants will be collected. A letter will be sent to the GP to inform them of study participation. Questions around current addiction status will be guided by Section 1 of the Treatment Outcome Profile (TOP).
Analytic Plan Our study is very much feasibility focused and not hypothesis driven so formal power calculations are not directly applicable. Prospectively, potential participants that meet the study eligibility criteria will be invited to participate. Descriptive statistics will summarize participant demographics and feasibility measures such as attendance rates. Nominal or ordinal variables will be reported as frequencies and percentages. Continuous variables will be summarized as mean and standard deviation if normally distributed and median and inter-quartile range if non-normally distributed. Data will be tested for normality using the Kolmogorov-Smirnov test and will be compared across timepoints using the general linear model procedure (normally distributed data) and the Friedman's test (non-normally distributed data). As participants will be heterogeneous, data will be sub-stratified and participants will be grouped meaningfully. Free text responses from subjective questions will be reported and organized into topic areas.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clients accessing services in the Advance Ballyfermot Project (Dublin)
Key inclusion criteria (1 listed)
- Any person (>18 years) accessing services in Ballyfermot Advance
Key exclusion criteria (2 listed)
- Any person with acute problematic behavioural issues, confusion or major physical problems
- Females with confirmed pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 12-week, low threshold physical rehabilitation intervention with protein supplementationAlso: Physical rehabilitation intervention with protein supplementation12 week, low threshold, rolling exercise intervention with protein supplementation | Other | – |
Primary outcome
Recruitment
Time frame: October to December 2022
Number recruited to study
Adverse events
Time frame: Through to study completion, up to 12 weeks
Any injuries or incidence will be recorded
Adherence
Time frame: Through to study completion, up to 12 weeks
Number of repeat visits
13 secondary outcomes
Hand-grip dynamometer
Time frame: Baseline and 12 weeks
Limb circumference measurement
Time frame: Baseline and 12 weeks
The Two Minute Walk Test
Time frame: Baseline and 12 weeks
Numerical Rating Scale
Time frame: Baseline and 12 weeks
Clinical Frailty Scale
Time frame: Baseline and 12 weeks
SHARE Frailty instrument
Time frame: Baseline and 12 weeks
Mini-nutritional assessment
Time frame: Baseline and 12 weeks
Body mass Index
Time frame: Baseline and 12 weeks
Self-report open ended questions
Time frame: Baseline and 12 weeks
The 10 Metre Walk Test
Time frame: Baseline and 12 weeks
Single Leg Stance Test
Time frame: Bseline and 12 weeks
The 30-Second Chair Stand Test
Time frame: Baseline and 12 weeks
Short Form 12
Time frame: Baseline and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Derived from this study: PubMed 41946023Kennedy F, Cheallaigh CN, Romero-Ortuno R, Murray D, Broderick J. 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. Physiotherapy. 2026 Sep;132:101873. doi: 10.1016/j.physio.2025.101873. Epub 2025 Dec 20.
- Derived from this study: PubMed 39913349Kennedy F, Murray D, Ni Cheallaigh C, Romero-Ortuno R, Broderick J. 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. PLoS One. 2025 Feb 6;20(2):e0300412. doi: 10.1371/journal.pone.0300412. eCollection 2025.
- Derived from this study: PubMed 39626407Kennedy F, Ni Cheallaigh C, Romero-Ortuno R, Murray D, Broderick J. 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. Physiotherapy. 2025 Mar;126:101449. doi: 10.1016/j.physio.2024.101449. Epub 2024 Nov 7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Broderick principal investigator
University of Dublin, Trinity College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Social Isolation and Chronic Disease, run by University of Dublin, Trinity College at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: October to December 2022). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05700305, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023.