Home-based Exercise for SMI

NCT06078293 | Withdrawn

• 2 other identifiers: E5010-WRX005010
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Serious Mental Illness

Keywords

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

Outcome Measures

Primary Outcomes (9)

• 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)

Study Arms (1)

Exercise

EXPERIMENTAL

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

Interventions

Home-based Exercise Program BEHAVIORAL

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

Exercise

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Providence VA Medical Center, Providence, RI

Providence, Rhode Island, 02908-4734, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Bipolar Disorder; Motor Activity

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders; Behavior

Study Officials

• Julia W Browne, PhD

  Providence VA Medical Center, Providence, RI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2023
• First Posted: October 11, 2023
• Study Start: July 2, 2025
• Primary Completion: July 2, 2025
• Study Completion: July 2, 2025
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)