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Braining- Aerobic Physical Activity as Add on Treatment in Bipolar Depression
Braining - A Randomized Controlled Study on Moderate-vigorous Aerobic Physical Exercise (PE) as an add-on Treatment in Bipolar Disorder. Effects on Recovery Time and Long-term Prevention From Bipolar Depression
1 other identifier
interventional
54
1 country
1
Brief Summary
Hypothesis: the hypothesis of the study is that aerobic physical exercise (PE) performed with the method Braining accelerates recovery from bipolar depression as well as improves psychiatric and somatic health in individuals with bipolar depression Method: a randomized controlled trial with 54 patients with bipolar depression are randomized to 6 weeks of either 1) supervised aerobic PE 3 times/week, 2) supervised relaxation/stretching 3 times/week or 3) information about PE but no supervised activity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2022
CompletedFirst Posted
Study publicly available on registry
April 22, 2022
CompletedStudy Start
First participant enrolled
October 26, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 20, 2029
February 10, 2026
February 1, 2026
5.2 years
March 31, 2022
February 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
PHQ-9 (Patient Health Questionnaire - 9 items)
Self rated depressive symptoms. Minimum value 0, maximum value 27, where higher values indicate more depressive symptoms.
Change from inclusion to follow up 6 weeks after inclusion
PHQ-9 (Patient Health Questionnaire - 9 items)
Self rated depressive symptoms. Minimum value 0, maximum value 27, where higher values indicate more depressive symptoms.
At follow up 12 months after intervention.
PHQ-9 (Patient Health Questionnaire - 9 items)
Self rated depressive symptoms. Minimum value 0, maximum value 27, where higher values indicate more depressive symptoms.
At follow up 24 months after intervention.
PHQ-9 (Patient Health Questionnaire - 9 items)
Self rated depressive symptoms. Minimum value 0, maximum value 27, where higher values indicate more depressive symptoms.
At follow up 36 months after intervention.
Secondary Outcomes (69)
MADRS (Montgomery-Åsberg Depression Rating Scale)
Change from inclusion to follow up 6 weeks after inclusion
AS-18 (Affective self rating scale)
Change from inclusion to follow up 6 weeks after inclusion
AS-18 (Affective self rating scale)
At follow up 12 months after intervention.
AS-18 (Affective self rating scale)
At follow up 24 months after intervention.
AS-18 (Affective self rating scale)
At follow up 36 months after intervention.
- +64 more secondary outcomes
Study Arms (3)
Braining high intensity
EXPERIMENTALModerate to vigorous physical exercise, supervised by psychiatric staff 3 times per week
Braining relaxing exercise
ACTIVE COMPARATORRelaxation, light yoga or stretching exercise, supervised by psychiatric staff 3 times per week
Information about physical exercise
ACTIVE COMPARATORWritten and oral information about health benefits from physical exercise, provided by researcher on one occasion.
Interventions
Moderate to vigorous physical exercise 30-45 minutes in a group setting led by psychiatric staff, 3 times per week for 6 weeks
Relaxing exercises (stretching, light yoga) 30-45 minutes in a group setting led by psychiatric staff, 3 times per week for 6 weeks
Written and oral information about physical exercise recommendations, on one occasion, by researcher
Eligibility Criteria
You may qualify if:
- Patients at Psychiatry Southwest, Karolinska University Hospital Region Stockholm Sweden.
- Bipolar disorder
You may not qualify if:
- Severe psychiatric disorder such as mania and psychosis
- Medical conditions such as heart- and lung diseases where PE is contraindicated.
- Unable to understand written and spoken Swedish language.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Region Stockholmlead
- Karolinska Institutetcollaborator
Study Sites (1)
Region Stockholm, Psykiatri Sydväst (Psychiatric Clinic Psychiatry Southwest)
Stockholm, Stockholm County, 14186, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lina Martinsson, PhD
Karolinska Institutet
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2022
First Posted
April 22, 2022
Study Start
October 26, 2022
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
April 20, 2029
Last Updated
February 10, 2026
Record last verified: 2026-02