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Home-based Exercise for SMI

A Feasibility Study of Home-based Exercise for Older Veterans With Serious Mental Illness

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06078293
Enrollment
0
Registered
2023-10-11
Start date
2025-07-02
Completion date
2025-07-02
Last updated
2025-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Serious Mental Illness

Keywords

schizophrenia, schizoaffective disorder, bipolar disorder, exercise, physical function, home-based

Brief 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. 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.

Interventions

12-week home-based exercise program that involves individualized exercise prescription and motivational health coaching calls.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility/Acceptability as measured by eligibility rateThrough 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 studyThrough 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 adherenceEnd of intervention (12 weeks)Percentage of exercise sessions completed out of total number prescribed (60% is benchmark)
Feasibility/Acceptability as measured by coaching call adherenceEnd 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 fidelityEnd 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 fidelityEnd 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 ScoreEnd 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 retentionThrough 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 durationEnd of intervention (12 weeks)Length of the assessment battery in minutes (60 minutes is benchmark)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026