Clinical trial NCT06078293: Home-based Exercise for SMI
Official title: A Feasibility Study of Home-based Exercise for Older Veterans With Serious Mental Illness
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Serious Mental Illness
Keywords: schizophrenia
schizoaffective disorder
bipolar disorder
exercise
physical function
home-based
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2023-10-11
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Feasibility/Acceptability as measured by eligibility rate
timeFrame: Through completion of study (an average of 2 years)
measure: Feasibility/Acceptability as measured by number of participants enrolled in the study
timeFrame: Through completion of study (an average of 2 years)
measure: Feasibility/Acceptability as measured by exercise session adherence
timeFrame: End of intervention (12 weeks)
measure: Feasibility/Acceptability as measured by coaching call adherence
timeFrame: End of intervention (12 weeks)
measure: Feasibility/Acceptability as measured by orientation session fidelity
timeFrame: End of intervention (12 weeks)
measure: Feasibility/Acceptability as measured by coaching call session fidelity
timeFrame: End of intervention (12 weeks)
measure: Feasibility/Acceptability as measured by Client Satisfaction Questionnaire Total Score
timeFrame: End of intervention (12 weeks)
measure: Feasibility/Acceptability as measured by retention
timeFrame: Through completion of study (an average of 2 years)
measure: Feasibility/Acceptability as measured by assessment duration
timeFrame: End of intervention (12 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Providence VA Medical Center, Providence, RI
state: Rhode Island
Study officials:
affiliation: Providence VA Medical Center, Providence, RI
name: Julia W Browne, PhD
role: PRINCIPAL_INVESTIGATOR
References: