Home-based Exercise for SMI

• ClinicalTrials.gov Identifier: NCT06078293
• Recruitment Status: Not yet recruiting
• First Posted: October 11, 2023
• Last Update Posted: October 16, 2023
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

Tracking Information

• First Submitted Date: October 5, 2023
• First Posted Date: October 11, 2023
• Last Update Posted Date: October 16, 2023
• Estimated Study Start Date: August 3, 2026
• Estimated Primary Completion Date: November 6, 2028 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 12, 2023)

• 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)
• 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)
• 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)
• 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)
• 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)
• 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)
• 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).
• 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)
• 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)

Original Primary Outcome Measures (submitted: October 5, 2023)

• 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)
• 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)
• Feasibility/Acceptability as measured by exercise session adherence [ Time Frame: End of intervention (after 12 weeks) ]
  Percentage of exercise sessions completed out of total number prescribed (60% is benchmark)
• Feasibility/Acceptability as measured by coaching call adherence [ Time Frame: End of intervention (after 12 weeks) ]
  Percentage of motivational health coaching calls completed out of total scheduled (60% is benchmark)
• Feasibility/Acceptability as measured by orientation session fidelity [ Time Frame: End of intervention (after 12 weeks) ]
  Percentage of administered orientation sessions with a fidelity rating of at least adequate (80% is benchmark)
• Feasibility/Acceptability as measured by coaching call session fidelity [ Time Frame: End of intervention (after 12 weeks) ]
  Percentage of administered coaching calls with a fidelity rating of at least adequate (80% is benchmark)
• Feasibility/Acceptability as measured by Client Satisfaction Questionnaire Total Score [ Time Frame: End of intervention (after 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).
• 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)
• Feasibility/Acceptability as measured by assessment duration [ Time Frame: End of intervention (after 12 weeks) ]
  Length of the assessment battery in minutes (60 minutes is benchmark)

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Home-based Exercise for SMI
• Official Title: A Feasibility Study of Home-based Exercise for Older Veterans With Serious Mental Illness
• 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.
• 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
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Serious Mental Illness

Intervention

Behavioral: Home-based Exercise Program

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

Study Arms

Experimental: Exercise

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

Intervention: Behavioral: Home-based Exercise Program

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: October 5, 2023): 30
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 31, 2029
• Estimated Primary Completion Date: November 6, 2028 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT06078293
• Other Study ID Numbers: E5010-W; RX005010 ( Other Grant/Funding Number: VA RRD )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: VA Office of Research and Development
• Original Responsible Party: Same as current
• Current Study Sponsor: VA Office of Research and Development
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: VA Office of Research and Development
• Verification Date: October 2023