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Exercise as medicine? trial tests ways to boost activity in bipolar disorder

NCT ID NCT07767032

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time

Summary

This trial tests three different approaches to help people with bipolar disorder become more physically active. Participants are randomly assigned to receive brief advice alone, or brief advice plus supervised and home-based exercise with either health education or cognitive-behavioral sessions. The study aims to see which approach is most acceptable, feasible, and effective at increasing moderate-to-vigorous physical activity during a 12-week program and at a 6-month follow-up.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Behavioral interventions: brief advice, supervised and home-based exercise, health education, and cognitive-behavioral sessions to increase and maintain physical activity
What this could lead to
If successful, this could identify effective strategies to help people with bipolar disorder become and stay physically active, potentially improving their overall health and well-being.
What could go wrong
This is a small early-stage trial focused on feasibility and preliminary effects, so results may not be definitive or widely applicable. Participants may find it hard to stick with the exercise programs.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

22 people

The number who actually took part.

Started

Jan 2018

Finished

Apr 2020

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: 1. Low-active, i.e., have not participated regularly (more than 6 weeks in the last 12 weeks) in moderate-to-vigorous physical activity (MVPA) for no greater than 90 minutes per week for the past 12 weeks AND is not enrolled in a current program designed to increase physical activity (such as Miriam weight loss program, intensive physical therapy, or other research projects related to physical activity) 2. Able to walk one mile. The cardiorespiratory fitness test requires the participant to walk one mile. 3. Medically cleared for MVPA, documented by a note from their primary care provider. 4. No significant medical condition or physical disability that would interfere with physical activity or study participation. The investigators will exclude individuals with significant cardiovascular disease, hematologic disorders, and autoimmune disorders. The investigators will also exclude individuals who are planning a surgery in the next 9 months and those with dementia. 5. Meet criteria for BDI, BDII or BD NOS assessed by relevant modules of the Structured Interview for DSM Disorders (SCID) 6. Range scores for depression. Participants must have a QIDS score that is ≤20. 7. No Current/Recent Manic/Hypomanic Episode. Participants cannot meet criteria for mania or Hypomania in the past month as assessed by the relevant module of the SCID. 8. No current anorexia or bulimia diagnosis (past 3months). Rationale: The investigators have concerns about the safety of physical activity for individuals with these disorders. 9. No current psychotic symptoms (in past month), no history of schizophrenia and other psychotic disorders 10. No hazardous drug or alcohol use in the past 6 months, as assessed by: a. no substance abuse treatment in the past 6 months; and b. does not meet criteria for a moderate or severe substance use disorder in the past 6 months. 11. Depression is not very severe, i.e., QIDS score is \< 20. At high levels of depression severity, participants are at risk for psychiatric hospitalization, suicidality, and other problems that would interfere with physical activity. The investigators will provide referrals if needed for these individuals. 12. No suicidality requiring immediate treatment. The investigators will take necessary steps to ensure these individuals get appropriate assessment. 13. Not pregnant or planning on becoming pregnant in the next year. Although exercise is recommended for most pregnant women, risks and benefits of exercise, and type of exercise recommended, may change when one is pregnant. 14. Able to consent and complete study assessments. Participants must be able to understand English well enough to consent and complete assessments. Further, if participants are aged 60 or older, or if there is any concern about their cognitive capacity, participants will undergo a brief cognitive functioning screener, the Montreal Cognitive Assessment (MoCA). Participants must achieve a score within 1 SD of the mean for their age and education level to participate in the study (32). 15. Aged 18-65. 16. Able to make one of the 2 available exercise class times. 17. Receiving medication treatment for bipolar disorder 18. Body weight does not exceed 375 lbs. Most of our exercise machines do not accommodate individuals with a higher body weight. As a result, if the investigators recruit these individuals, they may not have the machines available to allow them to exercise.

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Conditions

The condition(s) this trial relates to.

bipolar disorder Motor Activity

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Butler Hospital

    Providence, Rhode Island, 02906, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.