Bipolar DisorderNCT05340686
Braining- Aerobic Physical Activity as Add on Treatment in Bipolar Depression
A study testing Aerobic Physical Exercise, Relaxing Physical Exercise and Information about physical exercise in people with Bipolar Disorder and Bipolar Depression, run by Region Stockholm at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder, Bipolar Depression, Bipolar I Disorder
- What is being tested?
- Aerobic Physical Exercise, Relaxing Physical Exercise and Information about physical exercise
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSweden
- Study dates
- 26 Oct 2022to 20 Apr 2029
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients at Psychiatry Southwest, Karolinska University Hospital Region Stockholm Sweden.
- Bipolar disorder
- Ongoing depression, defined as a PHQ-9 score of 9 or higher at any occasion 2 weeks before inclusion.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Region Stockholm, Psykiatri Sydväst (Psychiatric Clinic Psychiatry Southwest)
Stockholm, Stockholm County, 14186
About this study
Official title: 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
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.
Read the detailed description
The hypothesis of this study is that adding aerobic PE might accelerate recovery, reduce negative side effects, improve mental wellbeing and function, increase long term prevention against relapsing bipolar episodes and reduce risk for complications such as cardiovascular disease in patients with bipolar disorder. Furthermore the study aims to evaluate if the effect of PE is linked to biological factors such as genetical factors, stress hormone levels, level of inflammation and other biological markers for health and disease that can be measured in standard blood samples.
Patients diagnosed with bipolar disorder with ongoing depression are invited to participate in the study at regular visits in the psychiatric clinic. All study participants are medicated with mood stabilizers according to routine treatment and receive regular treatment for bipolar depression. After informed consent the study participants will be randomized to one of three groups 1) moderate to vigorous PE group training together with psychiatric staff three times per week 2) relaxing and stretching exercises group training together with psychiatric staff three times per week 3) information about PE and relaxation but no supervised PE or relaxation/stretching, for the 6 weeks of the study period.
BEFORE: The first week consists of pre-test including interview regarding medical history and physical and psychiatric examination, ECG and blood samples. To measure level of physical activity the participants wear an activity monitor, Actiheart, that continuously registers physical activity for 7 days. The study participants will also fill out different questionnaires regarding general health and psychiatric symptoms.
STUDY PERIOD: During the 6 weeks long study period the participants fill out an activity questionnaire and health questionnaires once a week.
AFTER: during the sixth week of the study period evaluation is being performed with repetition of the physical and psychiatric examination, blood samples and questionnaires. After 1, 2 and 3 years after the exercise period the questionnaires are repeated. Blood samples are repeated one year after the study period.
- Conditions
- Bipolar Disorder, Bipolar Depression, Bipolar I Disorder, Bipolar II Disorder, Bipolar Affective Disorder; Remission in, Bipolar Affective Disorder, Currently Depressed, Moderate
- Being tested
- Aerobic Physical Exercise, Relaxing Physical Exercise, Information about physical exercise
- Keywords
- physical exercise, physical activity
- Medical subject headings
- Bipolar Disorder, Lymphoma, Follicular, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic Physical ExerciseBehavioural
Moderate to vigorous physical exercise 30-45 minutes in a group setting led by psychiatric staff, 3 times per week for 6 weeks
Relaxing Physical ExerciseBehavioural
Relaxing exercises (stretching, light yoga) 30-45 minutes in a group setting led by psychiatric staff, 3 times per week for 6 weeks
Information about physical exerciseBehavioural
Written and oral information about physical exercise recommendations, on one occasion, by researcher
| Study group | Role | What they receive |
|---|---|---|
| Braining high intensity | Experimental | Moderate to vigorous physical exercise, supervised by psychiatric staff 3 times per week Receives: Behavioral: Aerobic Physical Exercise |
| Braining relaxing exercise | Active comparator | Relaxation, light yoga or stretching exercise, supervised by psychiatric staff 3 times per week Receives: Behavioral: Relaxing Physical Exercise |
| Information about physical exercise | Active comparator | Written and oral information about health benefits from physical exercise, provided by researcher on one occasion. Receives: Behavioral: Information about physical exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
PHQ-9 (Patient Health Questionnaire - 9 items)
Self rated depressive symptoms. Minimum value 0, maximum value 27, where higher values indicate more depressive symptoms.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At follow up 36 months after intervention.
Secondary outcomes (69)
MADRS (Montgomery-Åsberg Depression Rating Scale)
Clinician-rated scale to assess degree of depressive symptoms. 10 items. Minimum value 0 and maximum value 60, where higher values indicate more depressive symptoms.
Measured: Change from inclusion to follow up 6 weeks after inclusion
AS-18 (Affective self rating scale)
Self-assessment of symptoms of depression and hypomania/mania. 9 items for depression and 9 items for mania. Score 0-72. A score of over 10 on the depressive or manic/hypomanic subscale should give rise to suspicion of ongoing depression and hypomania/mania respectively. Scores of over 10 on both the depressive and manic/hypomanic scale at the same time give may indicate an affective mixed state.
Measured: Change from inclusion to follow up 6 weeks after inclusion
AS-18 (Affective self rating scale)
Self-assessment of symptoms of depression and hypomania/mania. 9 items for depression and 9 items for mania. Score 0-72. A score of over 10 on the depressive or manic/hypomanic subscale should give rise to suspicion of ongoing depression and hypomania/mania respectively. Scores of over 10 on both the depressive and manic/hypomanic scale at the same time give may indicate an affective mixed state.
Measured: At follow up 12 months after intervention.
AS-18 (Affective self rating scale)
Self-assessment of symptoms of depression and hypomania/mania. 9 items for depression and 9 items for mania. Score 0-72. A score of over 10 on the depressive or manic/hypomanic subscale should give rise to suspicion of ongoing depression and hypomania/mania respectively. Scores of over 10 on both the depressive and manic/hypomanic scale at the same time give may indicate an affective mixed state.
Measured: At follow up 24 months after intervention.
AS-18 (Affective self rating scale)
Self-assessment of symptoms of depression and hypomania/mania. 9 items for depression and 9 items for mania. Score 0-72. A score of over 10 on the depressive or manic/hypomanic subscale should give rise to suspicion of ongoing depression and hypomania/mania respectively. Scores of over 10 on both the depressive and manic/hypomanic scale at the same time give may indicate an affective mixed state.
Measured: At follow up 36 months after intervention.
YMRS (Young Ziegler Mania Rating Scale)
Interviewer-rated scale. Includes 11 items; seven are rated from 0 (absent) to 4; four from 0 to 8; total scores range from 0 to 60. A higher value indicates worse symptoms of hypomania/mania.
Measured: Change from inclusion to follow up 6 weeks after inclusion
YMRS (Young Ziegler Mania Rating Scale)
Interviewer-rated scale. Includes 11 items; seven are rated from 0 (absent) to 4; four from 0 to 8; total scores range from 0 to 60. A higher value indicates worse symptoms of hypomania/mania.
Measured: At follow up 12 months after intervention.
YMRS (Young Ziegler Mania Rating Scale)
Interviewer-rated scale. Includes 11 items; seven are rated from 0 (absent) to 4; four from 0 to 8; total scores range from 0 to 60. A higher value indicates worse symptoms of hypomania/mania.
Measured: At follow up 24 months after intervention.
YMRS (Young Ziegler Mania Rating Scale)
Interviewer-rated scale. Includes 11 items; seven are rated from 0 (absent) to 4; four from 0 to 8; total scores range from 0 to 60. A higher value indicates worse symptoms of hypomania/mania.
Measured: At follow up 36 months after intervention.
CGI-S (Clinical Global Impressions - Severity Scale)
A one-item clinician assessed measure which evaluates the severity of psychopathology from 1 to 7, where 1 is 'normal' and 7 is 'among the most extremely ill patients' by the question "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?".
Measured: Change from inclusion to follow up 6 weeks after inclusion
CGI-S (Clinical Global Impressions - Severity Scale)
A one-item clinician assessed measure which evaluates the severity of psychopathology from 1 to 7, where 1 is 'normal' and 7 is 'among the most extremely ill patients' by the question "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?".
Measured: At follow up 12 months after intervention
CGI-S (Clinical Global Impressions - Severity Scale)
A one-item clinician assessed measure which evaluates the severity of psychopathology from 1 to 7, where 1 is 'normal' and 7 is 'among the most extremely ill patients' by the question "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?".
Measured: At follow up 24 months after intervention
CGI-S (Clinical Global Impressions - Severity Scale)
A one-item clinician assessed measure which evaluates the severity of psychopathology from 1 to 7, where 1 is 'normal' and 7 is 'among the most extremely ill patients' by the question "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?".
Measured: At follow up 36 months after intervention
Blood pressure
systolic and diastolic, mmHg
Measured: Change from inclusion to follow up 6 weeks after inclusion
Blood pressure
systolic and diastolic, mmHg
Measured: At follow up 12 months after intervention
Blood pressure
systolic and diastolic, mmHg
Measured: At follow up 24 months after intervention
Blood pressure
systolic and diastolic, mmHg
Measured: At follow up 36 months after intervention
Heart rate
Heart rate, beats per minute
Measured: Change from inclusion to follow up 6 weeks after inclusion
Heart rate
Heart rate, beats per minute
Measured: At follow up 12 months after intervention
Heart rate
Heart rate, beats per minute
Measured: At follow up 24 months after intervention
Heart rate
Heart rate, beats per minute
Measured: At follow up 36 months after intervention
BMI (Body mass index)
Weight in kg divided by the square of height in m
Measured: Change from inclusion to follow up 6 weeks after inclusion
BMI (Body mass index)
Weight in kg divided by the square of height in m
Measured: At follow up 12 months after intervention
BMI (Body mass index)
Weight in kg divided by the square of height in m
Measured: At follow up 24 months after intervention
BMI (Body mass index)
Weight in kg divided by the square of height in m
Measured: At follow up 36 months after intervention
Waist circumference
Waist circumference, cm
Measured: Change from inclusion to follow up 6 weeks after inclusion
Waist circumference
Waist circumference, cm
Measured: At follow up 12 months after intervention
Waist circumference
Waist circumference, cm
Measured: At follow up 24 months after intervention
Waist circumference
Waist circumference, cm
Measured: At follow up 36 months after intervention
FBS (fasting blood sugar)
fasting blood sugar, mmol/l
Measured: Change from inclusion to follow up 6 weeks after inclusion
FBS (fasting blood sugar)
fasting blood sugar, mmol/l
Measured: At follow up 12 months after intervention.
FBS (fasting blood sugar)
fasting blood sugar, mmol/l
Measured: At follow up 24 months after intervention.
FBS (fasting blood sugar)
fasting blood sugar, mmol/l
Measured: At follow up 36 months after intervention.
HbA1c (Hemoglobin A1c)
Glycated hemoglobin, mmol/mol
Measured: Change from inclusion to follow up 6 weeks after inclusion
HbA1c (Hemoglobin A1c)
Glycated hemoglobin, mmol/mol
Measured: At follow up 12 months after intervention.
HbA1c (Hemoglobin A1c)
Glycated hemoglobin, mmol/mol
Measured: At follow up 24 months after intervention.
HbA1c (Hemoglobin A1c)
Glycated hemoglobin, mmol/mol
Measured: At follow up 36 months after intervention.
Blood lipids
Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, mmol/L
Measured: Change from inclusion to follow up 6 weeks after inclusion
Blood lipids
Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, mmol/L
Measured: At follow up 12 months after intervention.
Blood lipids
Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, mmol/L
Measured: At follow up 24 months after intervention.
Blood lipids
Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, mmol/L
Measured: At follow up 36 months after intervention.
CRP (C-reactive protein)
Measurement of inflammation and infection, mmol/L
Measured: Change from inclusion to follow up 6 weeks after inclusion
CRP (C-reactive protein)
Measurement of inflammation and infection, mmol/L
Measured: At follow up 12 months after intervention.
CRP (C-reactive protein)
Measurement of inflammation and infection, mmol/L
Measured: At follow up 24 months after intervention.
CRP (C-reactive protein)
Measurement of inflammation and infection, mmol/L
Measured: At follow up 36 months after intervention.
Telomere length
telomere length in leukocytes
Measured: Change from inclusion to follow up 6 weeks after inclusion
Telomere length
telomere length in leukocytes
Measured: At follow up 12 months after intervention.
Telomerase
Enzyme activity in blood
Measured: Change from inclusion to follow up 6 weeks after inclusion
Telomerase
Enzyme activity in blood
Measured: At follow up 12 months after intervention.
WHODAS 2.0 (World health organization disability assessment schedule)
Self rated disability. Minimum value 0, maximum value 100, where higher values indicate more disability.
Measured: Change from inclusion to follow up 6 weeks after inclusion
WHODAS 2.0 (World health organization disability assessment schedule)
Self rated disability. Minimum value 0, maximum value 100, where higher values indicate more disability.
Measured: At follow up 12 months after intervention.
WHODAS 2.0 (World health organization disability assessment schedule)
Self rated disability. Minimum value 0, maximum value 100, where higher values indicate more disability.
Measured: At follow up 24 months after intervention.
WHODAS 2.0 (World health organization disability assessment schedule)
Self rated disability. Minimum value 0, maximum value 100, where higher values indicate more disability.
Measured: At follow up 36 months after intervention.
EQ-5D-5L (EuroQol VAS)
Self-assessment instrument for describing and valuing health. Defines health in terms of five dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Also included is an overall health rating on a 0-100 hash-marked, vertical visual analogue scale (EQ-VAS). Assessment the scores from the descriptive component can be reported as a five digit number ranging from 11111 (full health) to 55555 (worst health). A number of methods exist for analysing these five digit profiles. However, frequently they are converted to a single utility index using country specific value sets. A higher index number indicates a poorer self-assessed health.
Measured: Change from inclusion to follow up 6 weeks after inclusion
EQ-5D-5L (EuroQol VAS)
Self-assessment instrument for describing and valuing health. Defines health in terms of five dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Also included is an overall health rating on a 0-100 hash-marked, vertical visual analogue scale (EQ-VAS). Assessment the scores from the descriptive component can be reported as a five digit number ranging from 11111 (full health) to 55555 (worst health). A number of methods exist for analysing these five digit profiles. However, frequently they are converted to a single utility index using country specific value sets. A higher index number indicates a poorer self-assessed health.
Measured: At follow up 12 months after intervention.
EQ-5D-5L (EuroQol VAS)
Self-assessment instrument for describing and valuing health. Defines health in terms of five dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Also included is an overall health rating on a 0-100 hash-marked, vertical visual analogue scale (EQ-VAS). Assessment the scores from the descriptive component can be reported as a five digit number ranging from 11111 (full health) to 55555 (worst health). A number of methods exist for analysing these five digit profiles. However, frequently they are converted to a single utility index using country specific value sets. A higher index number indicates a poorer self-assessed health.
Measured: At follow up 24 months after intervention.
EQ-5D-5L (EuroQol VAS)
Self-assessment instrument for describing and valuing health. Defines health in terms of five dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Also included is an overall health rating on a 0-100 hash-marked, vertical visual analogue scale (EQ-VAS). Assessment the scores from the descriptive component can be reported as a five digit number ranging from 11111 (full health) to 55555 (worst health). A number of methods exist for analysing these five digit profiles. However, frequently they are converted to a single utility index using country specific value sets. A higher index number indicates a poorer self-assessed health.
Measured: At follow up 36 months after intervention.
SRH (Self-rated health)
SRH is typically measured as a single-item, the most common wording of which is "In general, would you say your health is" with the response items "excellent," "very good," "good," "fair," or "poor."
Measured: Change from inclusion to follow up 6 weeks after inclusion
SRH (Self-rated health)
SRH is typically measured as a single-item, the most common wording of which is "In general, would you say your health is" with the response items "excellent," "very good," "good," "fair," or "poor."
Measured: At follow up 12 months after intervention.
SRH (Self-rated health)
SRH is typically measured as a single-item, the most common wording of which is "In general, would you say your health is" with the response items "excellent," "very good," "good," "fair," or "poor."
Measured: At follow up 24 months after intervention.
SRH (Self-rated health)
SRH is typically measured as a single-item, the most common wording of which is "In general, would you say your health is" with the response items "excellent," "very good," "good," "fair," or "poor."
Measured: At follow up 36 months after intervention.
BBQ (Brunnsviken Brief Quality of Life Questionnaire)
Self rated quality of life. Minimum value 0, maximum value 96, where higher values indicate higher quality of life satisfaction.
Measured: Change from inclusion to follow up 6 weeks after inclusion
BBQ (Brunnsviken Brief Quality of Life Questionnaire)
Self rated quality of life. Minimum value 0, maximum value 96, where higher values indicate higher quality of life satisfaction.
Measured: At follow up 12 months after intervention.
BBQ (Brunnsviken Brief Quality of Life Questionnaire)
Self rated quality of life. Minimum value 0, maximum value 96, where higher values indicate higher quality of life satisfaction.
Measured: At follow up 24 months after intervention.
BBQ (Brunnsviken Brief Quality of Life Questionnaire)
Self rated quality of life. Minimum value 0, maximum value 96, where higher values indicate higher quality of life satisfaction.
Measured: At follow up 36 months after intervention.
Occupational level measured in % of work ability in medical certificate
Complete sick leave 0%, partial sick leave 25-75 %, completely able to work 100%.
Measured: Change from inclusion to follow up 6 weeks after inclusion
Occupational level measured in % of work ability in medical certificate
Complete sick leave 0%, partial sick leave 25-75 %, completely able to work 100%.
Measured: At follow up 12 months after intervention.
Occupational level measured in % of work ability in medical certificate
Complete sick leave 0%, partial sick leave 25-75 %, completely able to work 100%.
Measured: At follow up 24 months after intervention.
Occupational level measured in % of work ability in medical certificate
Complete sick leave 0%, partial sick leave 25-75 %, completely able to work 100%.
Measured: At follow up 36 months after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start26 Oct 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion20 Apr 2029 (estimated)
Why it stopped: Difficulties recruiting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Region StockholmThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Collaborators
- Karolinska Institutet
- Responsible party
- Sponsor
- Investigators
- Lina Martinsson, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05340686
- Sponsor's protocol ID
- Braining Bipolar RCT
- Status last verified
- Feb 2026
- First submitted
- 31 Mar 2022
- Last updated
- 10 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05340686
- Acronym / sponsor ID
- Braining Bipolar RCT
- Conditions
- Bipolar Disorder, Bipolar Depression, Bipolar I Disorder, Bipolar II Disorder, Bipolar Affective Disorder; Remission in, Bipolar Affective Disorder, Currently Depressed, Moderate
- Keywords
- physical exercise, physical activity
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Difficulties recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Collaborators
- Karolinska Institutet
- Study start
- 26 Oct 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 20 Apr 2029 (estimated)
- First posted
- 22 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The hypothesis of this study is that adding aerobic PE might accelerate recovery, reduce negative side effects, improve mental wellbeing and function, increase long term prevention against relapsing bipolar episodes and reduce risk for complications such as cardiovascular disease in patients with bipolar disorder. Furthermore the study aims to evaluate if the effect of PE is linked to biological factors such as genetical factors, stress hormone levels, level of inflammation and other biological markers for health and disease that can be measured in standard blood samples.
Patients diagnosed with bipolar disorder with ongoing depression are invited to participate in the study at regular visits in the psychiatric clinic. All study participants are medicated with mood stabilizers according to routine treatment and receive regular treatment for bipolar depression. After informed consent the study participants will be randomized to one of three groups 1) moderate to vigorous PE group training together with psychiatric staff three times per week 2) relaxing and stretching exercises group training together with psychiatric staff three times per week 3) information about PE and relaxation but no supervised PE or relaxation/stretching, for the 6 weeks of the study period.
BEFORE: The first week consists of pre-test including interview regarding medical history and physical and psychiatric examination, ECG and blood samples. To measure level of physical activity the participants wear an activity monitor, Actiheart, that continuously registers physical activity for 7 days. The study participants will also fill out different questionnaires regarding general health and psychiatric symptoms.
STUDY PERIOD: During the 6 weeks long study period the participants fill out an activity questionnaire and health questionnaires once a week.
AFTER: during the sixth week of the study period evaluation is being performed with repetition of the physical and psychiatric examination, blood samples and questionnaires. After 1, 2 and 3 years after the exercise period the questionnaires are repeated. Blood samples are repeated one year after the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Braining high intensity | Experimental | Behavioral: Aerobic Physical ExerciseModerate to vigorous physical exercise, supervised by psychiatric staff 3 times per week |
| Braining relaxing exercise | Active comparator | Behavioral: Relaxing Physical ExerciseRelaxation, light yoga or stretching exercise, supervised by psychiatric staff 3 times per week |
| Information about physical exercise | Active comparator | Behavioral: Information about physical exerciseWritten and oral information about health benefits from physical exercise, provided by researcher on one occasion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients at Psychiatry Southwest, Karolinska University Hospital Region Stockholm Sweden.
- Bipolar disorder
- Ongoing depression, defined as a PHQ-9 score of 9 or higher at any occasion 2 weeks before inclusion.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic Physical ExerciseModerate to vigorous physical exercise 30-45 minutes in a group setting led by psychiatric staff, 3 times per week for 6 weeks | Behavioural | Braining high intensity |
| Relaxing Physical ExerciseRelaxing exercises (stretching, light yoga) 30-45 minutes in a group setting led by psychiatric staff, 3 times per week for 6 weeks | Behavioural | Braining relaxing exercise |
| Information about physical exerciseWritten and oral information about physical exercise recommendations, on one occasion, by researcher | Behavioural | Information about physical exercise |
Primary outcome
PHQ-9 (Patient Health Questionnaire - 9 items)
Time frame: Change from inclusion to follow up 6 weeks after inclusion
Self rated depressive symptoms. Minimum value 0, maximum value 27, where higher values indicate more depressive symptoms.
PHQ-9 (Patient Health Questionnaire - 9 items)
Time frame: At follow up 12 months after intervention.
Self rated depressive symptoms. Minimum value 0, maximum value 27, where higher values indicate more depressive symptoms.
PHQ-9 (Patient Health Questionnaire - 9 items)
Time frame: At follow up 24 months after intervention.
Self rated depressive symptoms. Minimum value 0, maximum value 27, where higher values indicate more depressive symptoms.
PHQ-9 (Patient Health Questionnaire - 9 items)
Time frame: At follow up 36 months after intervention.
Self rated depressive symptoms. Minimum value 0, maximum value 27, where higher values indicate more depressive symptoms.
69 secondary outcomes
MADRS (Montgomery-Åsberg Depression Rating Scale)
Time frame: Change from inclusion to follow up 6 weeks after inclusion
AS-18 (Affective self rating scale)
Time frame: Change from inclusion to follow up 6 weeks after inclusion
AS-18 (Affective self rating scale)
Time frame: At follow up 12 months after intervention.
AS-18 (Affective self rating scale)
Time frame: At follow up 24 months after intervention.
AS-18 (Affective self rating scale)
Time frame: At follow up 36 months after intervention.
YMRS (Young Ziegler Mania Rating Scale)
Time frame: Change from inclusion to follow up 6 weeks after inclusion
YMRS (Young Ziegler Mania Rating Scale)
Time frame: At follow up 12 months after intervention.
YMRS (Young Ziegler Mania Rating Scale)
Time frame: At follow up 24 months after intervention.
YMRS (Young Ziegler Mania Rating Scale)
Time frame: At follow up 36 months after intervention.
CGI-S (Clinical Global Impressions - Severity Scale)
Time frame: Change from inclusion to follow up 6 weeks after inclusion
CGI-S (Clinical Global Impressions - Severity Scale)
Time frame: At follow up 12 months after intervention
CGI-S (Clinical Global Impressions - Severity Scale)
Time frame: At follow up 24 months after intervention
CGI-S (Clinical Global Impressions - Severity Scale)
Time frame: At follow up 36 months after intervention
Blood pressure
Time frame: Change from inclusion to follow up 6 weeks after inclusion
Blood pressure
Time frame: At follow up 12 months after intervention
Blood pressure
Time frame: At follow up 24 months after intervention
Blood pressure
Time frame: At follow up 36 months after intervention
Heart rate
Time frame: Change from inclusion to follow up 6 weeks after inclusion
Heart rate
Time frame: At follow up 12 months after intervention
Heart rate
Time frame: At follow up 24 months after intervention
Heart rate
Time frame: At follow up 36 months after intervention
BMI (Body mass index)
Time frame: Change from inclusion to follow up 6 weeks after inclusion
BMI (Body mass index)
Time frame: At follow up 12 months after intervention
BMI (Body mass index)
Time frame: At follow up 24 months after intervention
BMI (Body mass index)
Time frame: At follow up 36 months after intervention
Waist circumference
Time frame: Change from inclusion to follow up 6 weeks after inclusion
Waist circumference
Time frame: At follow up 12 months after intervention
Waist circumference
Time frame: At follow up 24 months after intervention
Waist circumference
Time frame: At follow up 36 months after intervention
FBS (fasting blood sugar)
Time frame: Change from inclusion to follow up 6 weeks after inclusion
FBS (fasting blood sugar)
Time frame: At follow up 12 months after intervention.
FBS (fasting blood sugar)
Time frame: At follow up 24 months after intervention.
FBS (fasting blood sugar)
Time frame: At follow up 36 months after intervention.
HbA1c (Hemoglobin A1c)
Time frame: Change from inclusion to follow up 6 weeks after inclusion
HbA1c (Hemoglobin A1c)
Time frame: At follow up 12 months after intervention.
HbA1c (Hemoglobin A1c)
Time frame: At follow up 24 months after intervention.
HbA1c (Hemoglobin A1c)
Time frame: At follow up 36 months after intervention.
Blood lipids
Time frame: Change from inclusion to follow up 6 weeks after inclusion
Blood lipids
Time frame: At follow up 12 months after intervention.
Blood lipids
Time frame: At follow up 24 months after intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lina Martinsson, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Physical Exercise, Relaxing Physical Exercise and Information about physical exercise in people with Bipolar Disorder and Bipolar Depression, run by Region Stockholm at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PHQ-9 (Patient Health Questionnaire - 9 items) (time frame: Change from inclusion to follow up 6 weeks after inclusion). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.