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Peer Support for Exercise in Older Veterans With Psychotic Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02958007
Recruitment Status : Active, not recruiting
First Posted : November 8, 2016
Last Update Posted : January 11, 2021
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Description
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Brief Summary:
Older adults with psychotic disorders experience a dual set of challenges: those related to serious mental illness, and those related to aging. They have medical, cognitive, psychological and social difficulties; as a result they have an almost four times greater likelihood of early institutionalization in nursing homes. These challenges make it difficult for this group to engage in health behaviors, such as exercise. This is unfortunate, since participation in health-promoting activities is essential for maintaining functional independence with age. This study aims to develop and pilot test a peer coaching intervention for older Veterans with psychotic disorders, in which VA Peer Specialists, who are Veterans in recovery from mental illness, will provide intensive coaching to older Veterans with psychotic disorders to promote their participation in exercise and physical activity. Results from this study will inform us as to whether this intervention is acceptable to Veterans, feasible to implement, and effective in increasing exercise, physical activity, and physical fitness/function.

Condition or disease Intervention/treatment Phase
Psychotic Disorder Behavioral: Peer Education on Exercise for Recovery Behavioral: Enhanced supervised fitness training Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Peer Support for Exercise in Older Veterans With Psychotic Disorders
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : May 31, 2022

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Peer Education on Exercise for Recovery
A 24-week group-based peer coaching intervention delivered by a VA Peer Specialist, to promote participation in a supervised fitness training program and general physical activity
 Behavioral: Peer Education on Exercise for Recovery
A 24-week group-based peer coaching intervention delivered by a VA Peer Specialist, to promote participation in a supervised fitness training program and general physical activity
Active Comparator: Enhanced supervised fitness training
A 24-week intervention to promote participation in a supervised fitness training program and general physical activity, which includes individual support from non-peer staff
 Behavioral: Enhanced supervised fitness training
A 24-week intervention to promote participation in a supervised fitness training program and general physical activity, which includes individual support from non-peer staff


Outcome Measures
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Primary Outcome Measures :
  1. Intervention engagement [ Time Frame: 12 weeks ]
    Percent of participants randomized to PEER who attend at least three group sessions

  2. Intervention fidelity [ Time Frame: 12 weeks ]
    Percent of sampled PEER group sessions in which the peer coaches were adequately adherent (i.e., average score equal to "acceptable" and no items scored as "unacceptable") on the PEER fidelity measure

  3. Attendance- mean number of supervised fitness training sessions attended [ Time Frame: 12 weeks ]
    Attendance- mean number of supervised fitness training sessions attended

  4. Change from baseline in Ambulatory Physical Activity [ Time Frame: 12 weeks ]
    Weekly step-counts will be measured by pedometer

  5. Change from baseline in Maximal Aerobic Capacity (Vo2Max) [ Time Frame: 12 weeks ]
    Maximum rate of oxygen consumption as measured during incremental exercise on a motorized treadmill


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Current diagnosis of a psychotic disorder, meeting criteria established by the VA Serious Mental Illness Treatment Research and Evaluation Center (SMITREC): schizophrenic disorders (295.0-295.9), affective psychoses (296.0-296.1, 296.4-296.8), or major depression with psychotic features (296.24, 296.34)
  • age 50 or older
  • participation in mental health services at the VA Maryland Healthcare System
  • sufficient clinical stability to participate as deemed by a mental health treatment provider and/or chart review
  • sufficient medical stability as deemed by a medical provider

Exclusion Criteria:

  • Current participation in a supervised exercise program

  • medical conditions which would preclude exercise participation including:

    • unstable angina
    • proliferative diabetic retinopathy
    • oxygen dependence
    • frank incontinence
    • open wounds
    • poorly controlled Type 2 diabetes (HbA1c > 9%)
    • current treatment for active cancer
    • New York Heart Association Stage II-IV heart failure
    • dialysis for chronic kidney disease
    • myocardial infarction in the previous three months
  • inability to complete the Graded Exercise Treadmill Test
  • positive cardiac stress test, unless symptomatic coronary artery disease is ruled out by imaging studies
  • problematic substance abuse/dependence
  • imminent risk of suicidal or homicidal behavior
  • lack of capacity to consent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02958007


Locations
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United States, Maryland
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Anjana Muralidharan, PhD Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
More Information
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02958007    
Other Study ID Numbers: D2339-W
1IK2RX002339-01A1 ( U.S. NIH Grant/Contract )
First Posted: November 8, 2016    Key Record Dates
Last Update Posted: January 11, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Mental Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders