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Home-based Exercise for SMI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06078293
Recruitment Status : Not yet recruiting
First Posted : October 11, 2023
Last Update Posted : October 16, 2023
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Description
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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.

Condition or disease Intervention/treatment Phase
Serious Mental Illness Behavioral: Home-based Exercise Program Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Feasibility Study of Home-based Exercise for Older Veterans With Serious Mental Illness
Estimated Study Start Date : August 3, 2026
Estimated Primary Completion Date : November 6, 2028
Estimated Study Completion Date : July 31, 2029

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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).

  8. 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)

  9. 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)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06078293


Contacts
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Contact: Julia W Browne, PhD (401) 273-7100 ext 15051 Julia.Browne@va.gov
Contact: Melanie Parent, BA (401) 273-7100 ext 6293 Melanie.Parent@va.gov

Locations
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United States, Rhode Island
Providence VA Medical Center, Providence, RI
Providence, Rhode Island, United States, 02908-4734
Contact: Julia W Browne, PhD    401-273-7100 ext 15051    Julia.Browne@va.gov   
Principal Investigator: Julia W Browne, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Julia W Browne, PhD Providence VA Medical Center, Providence, RI
More Information
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT06078293    
Other Study ID Numbers: E5010-W
RX005010 ( Other Grant/Funding Number: VA RRD )
First Posted: October 11, 2023    Key Record Dates
Last Update Posted: October 16, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by VA Office of Research and Development:
schizophrenia
schizoaffective disorder
bipolar disorder
 exercise
physical function
home-based
Additional relevant MeSH terms:
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Mental Disorders