Home-Based Exercise for Serious Mental Illness

Overseen By Melanie Parent, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Alzheimer's, Dementia, Unstable angina, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a home-based exercise program designed to assist older Veterans with serious mental illnesses such as schizophrenia, schizoaffective disorder, or bipolar disorder. The goal is to determine if home exercise can improve physical abilities like endurance, strength, and mobility, which are often reduced in this group. Veterans who have not recently changed their psychiatric treatment, are medically cleared for exercise, and do not currently exercise regularly may be suitable candidates.

As an unphased trial, this study provides Veterans the chance to contribute to research that could improve their physical health and well-being.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, it requires that your psychiatric treatment has not changed in the prior month, suggesting you should be stable on your current medications.

What prior data suggests that this home-based exercise program is safe for older Veterans with serious mental illness?

Research has shown that exercise programs are generally safe for people with serious mental health issues. One study found that exercising at home is both feasible and safe. Exercise can help manage symptoms such as stress and low confidence, and most people respond well to these programs.

Another study examined the safety of exercise and found that even individuals at high risk for heart disease could participate safely with the right precautions. This indicates that exercise programs are usually well-tolerated, even for those with health concerns.

Therefore, strong evidence supports the safety of the home-based exercise program for participants considering joining this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the home-based exercise program for serious mental illness because it offers a convenient and accessible alternative to traditional treatments like medication and therapy sessions. Unlike standard care options that often require regular visits to healthcare facilities, this program allows participants to engage in physical activity from the comfort of their own homes, potentially increasing adherence and reducing barriers to care. Moreover, exercise has the added benefit of improving overall physical health, which is particularly important for individuals with serious mental illnesses who may face increased health risks.

What evidence suggests that this home-based exercise program is effective for improving physical function in older Veterans with serious mental illness?

Research has shown that exercise can greatly improve the quality of life for people with severe mental illness. One study found that exercise helps manage symptoms by providing mental clarity and reducing stress. Another study found that lifestyle changes, including exercise, offer small to modest benefits for physical health. Additionally, exercise boosts emotional well-being, confidence, and motivation in people with severe mental illness. These findings suggest that a home-based exercise program, provided to all participants in this trial, could enhance physical abilities and overall well-being in older Veterans with serious mental illness. ^{3 4 6 7 8}

Who Is on the Research Team?

Julia W Browne, PhD

Principal Investigator

Providence VA Medical Center, Providence, RI

Are You a Good Fit for This Trial?

This trial is for older Veterans aged 50+ with serious mental illnesses like schizophrenia, schizoaffective disorder, or bipolar disorder. They must be stable with no recent hospital stays for mental health issues and medically cleared to exercise. Those already exercising regularly or enrolled in a VA program, or with conditions like unstable angina or dementia cannot join.

Inclusion Criteria

I have been diagnosed with schizophrenia, schizoaffective disorder, or bipolar disorder.

Veteran enrolled at Providence VAHCS

I am 50 years old or older.

Exclusion Criteria

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

I have been diagnosed with Alzheimer's or a similar type of dementia.

I do not have medical conditions like unstable heart pain, severe eye problems due to diabetes, need for constant oxygen, or uncontrollable urine leakage that would prevent me from exercising.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Home-based Exercise Program

Participants engage in a 12-week home-based exercise program tailored for older Veterans with serious mental illness

12 weeks

Regular coaching calls

Follow-up

Participants are monitored for feasibility and acceptability of the exercise program

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Home-based Exercise Program

Trial Overview The study is testing the effectiveness of a home-based exercise program designed to improve physical function and quality of life in older Veterans with serious mental illness. It aims to see if this approach is practical and well-received by participants.

How Is the Trial Designed?

Group I: Exercise Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

Exercise interventions have shown positive health outcomes for hospitalized patients with depression, based on a systematic review of eight studies, indicating that exercise can be beneficial in acute mental health settings.

However, the evidence for the effectiveness of exercise in hospitalized patients with schizophrenia, bipolar disorder, or anxiety disorders is limited, highlighting a need for more research to determine the best exercise approaches for these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise for mental illness: a systematic review of inpatient studies. Stanton, R., Happell, B.[2018]

This feasibility study aims to assess the effectiveness of high-intensity interval training (HIIT) in improving physical and mental health among inpatients with severe mental illnesses (SMI), involving 40 patients in a randomized controlled trial over 12 weeks.

If HIIT is found to be feasible and acceptable, it could lead to larger studies evaluating its clinical and cost-effectiveness in inpatient mental health settings, potentially reversing cardiometabolic disease risks associated with SMI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol for a pilot high-intensity interval training intervention in inpatient mental health settings: a two-part study using a randomised controlled trial and naturalistic study design. Martland, R., Onwumere, J., Stubbs, B., et al.[2021]

Physical exercise has been shown to significantly benefit individuals with severe mental illnesses like schizophrenia by improving cognitive functions, global functioning, and alleviating negative symptoms, while also promoting neurogenesis and angiogenesis.

Successful engagement in physical activity programs for those with mental illnesses is enhanced when the programs are enjoyable, promote personal choice, and provide social support, highlighting the need for better integration of mental health services with community exercise resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Schizophrenia spectrum disorders and physical exercise]. Makris, K., Kollias, K.[2021]

A systematic review of 19 studies suggests that aerobic exercise can benefit individuals with schizophrenia by improving both positive symptoms (like hallucinations) and negative symptoms, with effects potentially noticeable shortly after starting the program.

Despite the promising results, the studies often had small sample sizes and methodological weaknesses, highlighting the need for larger, well-designed trials to confirm the efficacy and safety of exercise as a treatment for schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Benefits of exercise for people with schizophrenia: a systematic review]. Bernard, P., Ninot, G.[2018]

An exercise program for individuals with serious mental illness was found to be feasible, with regular attendance from participants who self-selected to join the exercise group, which met three times a week for 50 minutes.

Both the exercise group (N=38) and the control group (N=28) showed similar improvements in symptoms and psychological well-being, indicating that exercise can be an effective adjunct treatment, although demographic factors influenced participation rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An adjunct exercise program for serious mental illness: who chooses to participate and is it feasible? Sylvia, LG., Kopeski, L., Brown, C., et al.[2021]

Exercise interventions in inpatient mental health settings significantly improved depression symptoms, with a moderate effect size (Standardized mean difference = -0.416) across 15 studies, indicating their potential therapeutic benefits.

No serious adverse events were reported from exercise, and most participants found the interventions enjoyable, with over 80% attendance; however, only five trials provided post-discharge support for continued exercise, highlighting a need for better systems to maintain engagement after leaving the hospital.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of exercise interventions for all types of inpatients across mental health settings: A systematic review and meta-analysis of 47 studies. Martland, R., Korman, N., Firth, J., et al.[2023]

Citations

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Experiences of exercise services for individuals with ... Exercise helps manage severe mental illness symptoms, providing clarity and stress reduction. Exercise enhances emotional outcomes, confidence, and motivation.

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Patient-reported outcomes of lifestyle interventions in patients ... Lifestyle interventions for severe mental illness (SMI) are known to have small to modest effect on physical health outcomes.

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Safety considerations when promoting exercise in ... Histories and physical exams, completed prior to starting a weight loss program, showed that 52% (N=106) had high risk for CAD, 40% had difficulty ...

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Systematic review of physical activity interventions ... The aim of this study was to systematically review the effectiveness of physical activity programmes on mental and physical health and specifically on reducing ...