Exercise as medicine? trial tests ways to boost activity in bipolar disorder
NCT ID NCT07767032
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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22 people
The number who actually took part.
- Started
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Jan 2018
- Finished
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Apr 2020
- Lead sponsor
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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
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Butler Hospital
Providence, Rhode Island, 02906, United States
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