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?

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.

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.

Is home-based exercise safe for people with serious mental illness?

Research suggests that exercise is generally safe and beneficial for people with serious mental illness, improving both physical and mental health. However, more studies are needed to standardize exercise programs and report any potential adverse events. ^{1 2 3 4 5}

How is the home-based exercise program treatment different from other treatments for serious mental illness?

The home-based exercise program is unique because it allows individuals with serious mental illness to engage in physical activity from the comfort of their own homes, which can help reduce anxiety and stress. Unlike traditional treatments that may require visits to rehabilitation centers or hospitals, this program offers flexibility and accessibility, making it easier for patients to incorporate exercise into their daily routines. ^{1 2 6 7 8}

What data supports the effectiveness of the home-based exercise program treatment for serious mental illness?

Research shows that exercise can improve symptoms of depression and other mental health conditions, similar to the effects of medication and therapy. Exercise is also seen as beneficial for improving overall health and well-being in people with serious mental illness. ^{1 2 9 10 11}

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]

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]

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]

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]

Citations

1. Australia pubmed.ncbi.nlm.nih.gov

Exercise for mental illness: a systematic review of inpatient studies. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

An adjunct exercise program for serious mental illness: who chooses to participate and is it feasible? [2021]

3. England pubmed.ncbi.nlm.nih.gov

EPA guidance on physical activity as a treatment for severe mental illness: a meta-review of the evidence and Position Statement from the European Psychiatric Association (EPA), supported by the International Organization of Physical Therapists in Mental Health (IOPTMH). [2022]

4. England 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. [2023]

5. Uganda pubmed.ncbi.nlm.nih.gov

A quantitative assessment of the views of mental health professionals on exercise for people with mental illness: perspectives from a low-resource setting. [2023]

6. Greece pubmed.ncbi.nlm.nih.gov

[Schizophrenia spectrum disorders and physical exercise]. [2021]

7. France pubmed.ncbi.nlm.nih.gov

[Benefits of exercise for people with schizophrenia: a systematic review]. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Increasing US health plan coverage for exercise programming in community mental health settings for people with serious mental illness: a position statement from the Society of Behavior Medicine and the American College of Sports Medicine. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Physical activities and their importance to the health of people with severe mental illness in Sweden. [2012]

10. Germany pubmed.ncbi.nlm.nih.gov

[Patient Preferences for Exercise Therapy in People with Severe Mental Illness in Germany]. [2023]

11. England 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. [2021]