Home-based Exercise for SMI

Serious Mental Illness Clinical Trial

Official title:

A Feasibility Study of Home-based Exercise for Older Veterans With Serious Mental Illness

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06078293
• Other study ID #: E5010-W
• Secondary ID: RX005010
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 3, 2026
• Est. completion date: July 31, 2029

Study information

• Verified date: October 2023
• Source: VA Office of Research and Development
• Contact: Julia W Browne, PhD
• Phone: (401) 273-7100
• Email: Julia.Browne[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: July 31, 2029
• Est. primary completion date: November 6, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• 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.

Locations

Country	Name	City	State
United States	Providence VA Medical Center, Providence, RI	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility/Acceptability as measured by eligibility rate	Eligibility rate when screening participants (12% is benchmark)	Through completion of study (an average of 2 years)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	Feasibility/Acceptability as measured by assessment duration	Length of the assessment battery in minutes (60 minutes is benchmark)	End of intervention (12 weeks)