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Home-based Exercise for SMI

Primary Purpose

Serious Mental Illness

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home-based Exercise Program
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Serious Mental Illness focused on measuring schizophrenia, schizoaffective disorder, bipolar disorder, exercise, physical function, home-based

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Providence VA Medical Center, Providence, RI

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exercise

Arm Description

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

Outcomes

Primary Outcome Measures

Feasibility/Acceptability as measured by eligibility rate
Eligibility rate when screening participants (12% is benchmark)
Feasibility/Acceptability as measured by number of participants enrolled in the study
Number of participants enrolled in the study (benchmark is n=30)
Feasibility/Acceptability as measured by exercise session adherence
Percentage of exercise sessions completed out of total number prescribed (60% is benchmark)
Feasibility/Acceptability as measured by coaching call adherence
Percentage of motivational health coaching calls completed out of total scheduled (60% is benchmark)
Feasibility/Acceptability as measured by orientation session fidelity
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
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
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
Percentage of participants that completed the endpoint assessment (70% is benchmark)
Feasibility/Acceptability as measured by assessment duration
Length of the assessment battery in minutes (60 minutes is benchmark)

Secondary Outcome Measures

Full Information

First Posted
October 5, 2023
Last Updated
October 12, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT06078293
Brief Title
Home-based Exercise for SMI
Official Title
A Feasibility Study of Home-based Exercise for Older Veterans With Serious Mental Illness
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 3, 2026 (Anticipated)
Primary Completion Date
November 6, 2028 (Anticipated)
Study Completion Date
July 31, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Serious Mental Illness
Keywords
schizophrenia, schizoaffective disorder, bipolar disorder, exercise, physical function, home-based

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Experimental
Arm Description
All participants in this single-arm trial will be in the exercise arm and receive the home-based exercise program.
Intervention Type
Behavioral
Intervention Name(s)
Home-based Exercise Program
Intervention Description
12-week home-based exercise program that involves individualized exercise prescription and motivational health coaching calls.
Primary Outcome Measure Information:
Title
Feasibility/Acceptability as measured by eligibility rate
Description
Eligibility rate when screening participants (12% is benchmark)
Time Frame
Through completion of study (an average of 2 years)
Title
Feasibility/Acceptability as measured by number of participants enrolled in the study
Description
Number of participants enrolled in the study (benchmark is n=30)
Time Frame
Through completion of study (an average of 2 years)
Title
Feasibility/Acceptability as measured by exercise session adherence
Description
Percentage of exercise sessions completed out of total number prescribed (60% is benchmark)
Time Frame
End of intervention (12 weeks)
Title
Feasibility/Acceptability as measured by coaching call adherence
Description
Percentage of motivational health coaching calls completed out of total scheduled (60% is benchmark)
Time Frame
End of intervention (12 weeks)
Title
Feasibility/Acceptability as measured by orientation session fidelity
Description
Percentage of administered orientation sessions with a fidelity rating of at least adequate (80% is benchmark)
Time Frame
End of intervention (12 weeks)
Title
Feasibility/Acceptability as measured by coaching call session fidelity
Description
Percentage of administered coaching calls with a fidelity rating of at least adequate (80% is benchmark)
Time Frame
End of intervention (12 weeks)
Title
Feasibility/Acceptability as measured by Client Satisfaction Questionnaire Total Score
Description
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).
Time Frame
End of intervention (12 weeks)
Title
Feasibility/Acceptability as measured by retention
Description
Percentage of participants that completed the endpoint assessment (70% is benchmark)
Time Frame
Through completion of study (an average of 2 years)
Title
Feasibility/Acceptability as measured by assessment duration
Description
Length of the assessment battery in minutes (60 minutes is benchmark)
Time Frame
End of intervention (12 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julia W Browne, PhD
Phone
(401) 273-7100
Ext
15051
Email
Julia.Browne@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Melanie Parent, BA
Phone
(401) 273-7100
Ext
6293
Email
Melanie.Parent@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia W Browne, PhD
Organizational Affiliation
Providence VA Medical Center, Providence, RI
Official's Role
Principal Investigator
Facility Information:
Facility Name
Providence VA Medical Center, Providence, RI
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02908-4734
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julia W Browne, PhD
Phone
401-273-7100
Ext
15051
Email
Julia.Browne@va.gov
First Name & Middle Initial & Last Name & Degree
Julia W Browne, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Home-based Exercise for SMI

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