Serious Mental IllnessNCT06078293
Home-based Exercise for SMI
A study testing Home-based Exercise Program in people with Serious Mental Illness, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Older Veterans with serious mental illness (schizophrenia, schizoaffective disorder, bipolar disorder) have reduced physical function (endurance, strength, mobility) that leads to lower quality of life. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Serious Mental Illness
- What is being tested?
- Home-based Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2025to 2 Jul 2025
- Phase
- Interventional
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veteran enrolled at Providence VAHCS
- age 50 or older
- chart diagnosis of SMI (i.e., schizophrenia, schizoaffective disorder, or bipolar disorder)
- clinically stable defined as no inpatient psychiatric admission in the prior three months and no changes in psychiatric treatment in prior month
- medically safe to participate in exercise defined by no inpatient medical admission in prior three months and sign-off by Veteran's medical provider
Who cannot join
- diagnosis of Alzheimer's or related dementia
- presence of any medical contraindication for exercise including unstable angina, active proliferative diabetic retinopathy, oxygen dependence, or frank incontinence
- already participating in regular exercise defined as at least 60 minutes/week every week for prior six months or currently enrolled in a VA exercise or health promotion program
Trial locations and contacts
1 site in 1 country.
United States1 site
Providence VA Medical Center, Providence, RI
Providence, Rhode Island, 02908-4734
About this study
Official title: A Feasibility Study of Home-based Exercise for Older Veterans With Serious Mental Illness
Older Veterans with serious mental illness (schizophrenia, schizoaffective disorder, bipolar disorder) have reduced physical function (endurance, strength, mobility) that leads to lower quality of life. Exercise interventions are effective at improving physical function and could have a tremendous impact on this population. Despite the established benefits of exercise, there has been little work focused on improving multiple aspects of physical function in older Veterans with serious mental illness. The purpose of this study is to examine the feasibility and acceptability of a home-based exercise program for older Veterans with serious mental illness.
Read the detailed description
Older Veterans with serious mental illness (schizophrenia, schizoaffective disorder, bipolar disorder) have significantly compromised physical function that leads to heightened rates of falls, hospitalizations, nursing home admissions, as well as early mortality. In fact, this population's physical function is compromised across multiple domains including mobility, endurance, and strength. Exercise is effective for increasing all domains of physical function (i.e., mobility, endurance, strength) in older Veterans. But, environmental difficulties (e.g., lack of transportation), low motivation, and medical issues affecting older Veterans with serious mental illness contribute to low engagement rates and high dropout rates in facility-based exercise programs. Individualized home-based exercise programs, which are safe and effective for older Veterans with health challenges, could address the main barriers to exercise in older Veterans with serious mental illness by promoting greater accessibility and individual tailoring. The purpose of this study is to evaluate the feasibility and acceptability of a 12-week home-based exercise program for older Veterans with serious mental illness.
- Conditions
- Serious Mental Illness
- Being tested
- Home-based Exercise Program
- Keywords
- schizophrenia, schizoaffective disorder, bipolar disorder, exercise, physical function, home-based
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Bipolar Disorder, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based Exercise ProgramBehavioural
12-week home-based exercise program that involves individualized exercise prescription and motivational health coaching calls.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | All participants in this single-arm trial will be in the exercise arm and receive the home-based exercise program. Receives: Behavioral: Home-based Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility/Acceptability as measured by eligibility rate
Eligibility rate when screening participants (12% is benchmark)
Measured: Through completion of study (an average of 2 years)
Feasibility/Acceptability as measured by number of participants enrolled in the study
Number of participants enrolled in the study (benchmark is n=30)
Measured: Through completion of study (an average of 2 years)
Feasibility/Acceptability as measured by exercise session adherence
Percentage of exercise sessions completed out of total number prescribed (60% is benchmark)
Measured: End of intervention (12 weeks)
Feasibility/Acceptability as measured by coaching call adherence
Percentage of motivational health coaching calls completed out of total scheduled (60% is benchmark)
Measured: End of intervention (12 weeks)
Feasibility/Acceptability as measured by orientation session fidelity
Percentage of administered orientation sessions with a fidelity rating of at least adequate (80% is benchmark)
Measured: End of intervention (12 weeks)
Feasibility/Acceptability as measured by coaching call session fidelity
Percentage of administered coaching calls with a fidelity rating of at least adequate (80% is benchmark)
Measured: End of intervention (12 weeks)
Feasibility/Acceptability as measured by Client Satisfaction Questionnaire Total Score
Total score on the Client Satisfaction Questionnaire (CSQ-8), which is an 8-item measure with each item scored from 1-4 with higher scores representing greater acceptability of the intervention and the range of total scores spanning 8-32 (24 is benchmark).
Measured: End of intervention (12 weeks)
Feasibility/Acceptability as measured by retention
Percentage of participants that completed the endpoint assessment (70% is benchmark)
Measured: Through completion of study (an average of 2 years)
Feasibility/Acceptability as measured by assessment duration
Length of the assessment battery in minutes (60 minutes is benchmark)
Measured: End of intervention (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start2 Jul 2025
- Primary completion2 Jul 2025
- Study completion2 Jul 2025
Why it stopped: PI leaving position and ending funding award early
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Serious Mental IllnessStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Julia W Browne, PhD, Principal investigator, Providence VA Medical Center, Providence, RI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06078293
- Sponsor's protocol ID
- E5010-W
- Other IDs
- RX005010
- Status last verified
- Jul 2025
- First submitted
- 5 Oct 2023
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Home-based Exercise for Older Veterans With Serious Mental Illness
- ClinicalTrials.gov ID
- NCT06078293
- Acronym / sponsor ID
- E5010-W
- Conditions
- Serious Mental Illness
- Keywords
- schizophrenia, schizoaffective disorder, bipolar disorder, exercise, physical function, home-based
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI leaving position and ending funding award early
- Enrolment
- 0 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 2 Jul 2025 (actual)
- Primary completion
- 2 Jul 2025 (actual)
- Study completion
- 2 Jul 2025 (actual)
- First posted
- 11 Oct 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.
Older Veterans with serious mental illness (schizophrenia, schizoaffective disorder, bipolar disorder) have reduced physical function (endurance, strength, mobility) that leads to lower quality of life. Exercise interventions are effective at improving physical function and could have a tremendous impact on this population. Despite the established benefits of exercise, there has been little work focused on improving multiple aspects of physical function in older Veterans with serious mental illness. The purpose of this study is to examine the feasibility and acceptability of a home-based exercise program for older Veterans with serious mental illness.
Detailed description
Older Veterans with serious mental illness (schizophrenia, schizoaffective disorder, bipolar disorder) have significantly compromised physical function that leads to heightened rates of falls, hospitalizations, nursing home admissions, as well as early mortality. In fact, this population's physical function is compromised across multiple domains including mobility, endurance, and strength. Exercise is effective for increasing all domains of physical function (i.e., mobility, endurance, strength) in older Veterans. But, environmental difficulties (e.g., lack of transportation), low motivation, and medical issues affecting older Veterans with serious mental illness contribute to low engagement rates and high dropout rates in facility-based exercise programs. Individualized home-based exercise programs, which are safe and effective for older Veterans with health challenges, could address the main barriers to exercise in older Veterans with serious mental illness by promoting greater accessibility and individual tailoring. The purpose of this study is to evaluate the feasibility and acceptability of a 12-week home-based exercise program for older Veterans with serious mental illness.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: Home-based Exercise ProgramAll participants in this single-arm trial will be in the exercise arm and receive the home-based exercise program. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Veteran enrolled at Providence VAHCS
- age 50 or older
- chart diagnosis of SMI (i.e., schizophrenia, schizoaffective disorder, or bipolar disorder)
- clinically stable defined as no inpatient psychiatric admission in the prior three months and no changes in psychiatric treatment in prior month
- medically safe to participate in exercise defined by no inpatient medical admission in prior three months and sign-off by Veteran's medical provider
Key exclusion criteria (3 listed)
- diagnosis of Alzheimer's or related dementia
- presence of any medical contraindication for exercise including unstable angina, active proliferative diabetic retinopathy, oxygen dependence, or frank incontinence
- already participating in regular exercise defined as at least 60 minutes/week every week for prior six months or currently enrolled in a VA exercise or health promotion program
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 |
|---|---|---|
| Home-based Exercise Program12-week home-based exercise program that involves individualized exercise prescription and motivational health coaching calls. | Behavioural | Exercise |
Primary outcome
Feasibility/Acceptability as measured by eligibility rate
Time frame: Through completion of study (an average of 2 years)
Eligibility rate when screening participants (12% is benchmark)
Feasibility/Acceptability as measured by number of participants enrolled in the study
Time frame: Through completion of study (an average of 2 years)
Number of participants enrolled in the study (benchmark is n=30)
Feasibility/Acceptability as measured by exercise session adherence
Time frame: End of intervention (12 weeks)
Percentage of exercise sessions completed out of total number prescribed (60% is benchmark)
Feasibility/Acceptability as measured by coaching call adherence
Time frame: End of intervention (12 weeks)
Percentage of motivational health coaching calls completed out of total scheduled (60% is benchmark)
Feasibility/Acceptability as measured by orientation session fidelity
Time frame: End of intervention (12 weeks)
Percentage of administered orientation sessions with a fidelity rating of at least adequate (80% is benchmark)
Feasibility/Acceptability as measured by coaching call session fidelity
Time frame: End of intervention (12 weeks)
Percentage of administered coaching calls with a fidelity rating of at least adequate (80% is benchmark)
Feasibility/Acceptability as measured by Client Satisfaction Questionnaire Total Score
Time frame: End of intervention (12 weeks)
Total score on the Client Satisfaction Questionnaire (CSQ-8), which is an 8-item measure with each item scored from 1-4 with higher scores representing greater acceptability of the intervention and the range of total scores spanning 8-32 (24 is benchmark).
Feasibility/Acceptability as measured by retention
Time frame: Through completion of study (an average of 2 years)
Percentage of participants that completed the endpoint assessment (70% is benchmark)
Feasibility/Acceptability as measured by assessment duration
Time frame: End of intervention (12 weeks)
Length of the assessment battery in minutes (60 minutes is benchmark)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- 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.
Julia W Browne, PhD principal investigator
Providence VA Medical Center, Providence, RI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based Exercise Program in people with Serious Mental Illness, run by VA Office of Research and Development at 1 site in United States.
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 5 inclusion and 3 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: withdrawn, as of the sponsor's last update on 9 Jul 2025. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Feasibility/Acceptability as measured by eligibility rate (time frame: Through completion of study (an average of 2 years)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jul 2025.