Home-based Exercise for SMI

October 12, 2023 updated by: VA Office of Research and Development

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02908-4734
        • Providence VA Medical Center, Providence, RI
        • Contact:
        • Principal Investigator:
          • Julia W Browne, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise
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
12-week home-based exercise program that involves individualized exercise prescription and motivational health coaching calls.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Through completion of study (an average of 2 years)
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)
Through completion of study (an average of 2 years)
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)
Through completion of study (an average of 2 years)
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)
End of intervention (12 weeks)
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)
End of intervention (12 weeks)
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)
End of intervention (12 weeks)
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)
End of intervention (12 weeks)
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).
End of intervention (12 weeks)
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)
End of intervention (12 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Julia W Browne, PhD, Providence VA Medical Center, Providence, RI

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 3, 2026

Primary Completion (Estimated)

November 6, 2028

Study Completion (Estimated)

July 31, 2029

Study Registration Dates

First Submitted

October 5, 2023

First Submitted That Met QC Criteria

October 5, 2023

First Posted (Actual)

October 11, 2023

Study Record Updates

Last Update Posted (Actual)

October 16, 2023

Last Update Submitted That Met QC Criteria

October 12, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E5010-W
  • RX005010 (Other Grant/Funding Number: VA RRD)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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