Home-based Exercise for SMI

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Serious Mental Illness

Intervention / Treatment
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* Behavioral: Home-based Exercise Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>All participants in this single-arm trial will be in the exercise arm and receive the home-based exercise program. | Behavioral: Home-based Exercise Program<br>* 12-week home-based exercise program that involves individualized exercise prescription and motivational health coaching calls.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility/Acceptability as measured by eligibility rate | Eligibility rate when screening participants (12% is benchmark) | 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) | 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) | 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) | 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) | 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) | 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). | End of intervention (12 weeks) | 
| Feasibility/Acceptability as measured by retention | Percentage of participants that completed the endpoint assessment (70% is benchmark) | 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) | End of intervention (12 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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schizophrenia, schizoaffective disorder, bipolar disorder, exercise, physical function, home-based