Home-based Exercise for SMI

NCT ID: NCT06078293

Last Updated: 2025-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-02

Study Completion Date

2025-07-02

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.

Conditions

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Serious Mental Illness

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exercise

All participants in this single-arm trial will be in the exercise arm and receive the home-based exercise program.

Group Type EXPERIMENTAL

Home-based Exercise Program

Intervention Type BEHAVIORAL

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

Interventions

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Home-based Exercise Program

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

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julia W Browne, PhD

Role: PRINCIPAL_INVESTIGATOR

Providence VA Medical Center, Providence, RI

Locations

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Providence VA Medical Center, Providence, RI

Providence, Rhode Island, United States

Site Status

Countries

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United States

Other Identifiers

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RX005010

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

E5010-W

Identifier Type: -

Identifier Source: org_study_id

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