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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Suspended
- Sponsor
- Region Stockholm
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- PHQ-9 (Patient Health Questionnaire - 9 items)
Study Overview
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.
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Braining high intensity
Moderate to vigorous physical exercise, supervised by psychiatric staff 3 times per week
Intervention: Aerobic Physical Exercise (Behavioral)
Braining relaxing exercise
Relaxation, light yoga or stretching exercise, supervised by psychiatric staff 3 times per week
Intervention: Relaxing Physical Exercise (Behavioral)
Information about physical exercise
Written and oral information about health benefits from physical exercise, provided by researcher on one occasion.
Intervention: Information about physical exercise (Behavioral)
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- HbA1c (Hemoglobin A1c)(At follow up 36 months after intervention.)
- Telomerase(At follow up 12 months after intervention.)
- BBQ (Brunnsviken Brief Quality of Life Questionnaire)(At follow up 36 months after intervention.)
- Occupational level measured in % of work ability in medical certificate(At follow up 36 months after intervention.)
- MADRS (Montgomery-Åsberg Depression Rating Scale)(Change from inclusion to follow up 6 weeks after inclusion)
- YMRS (Young Ziegler Mania Rating Scale)(At follow up 36 months after intervention.)
- Waist circumference(At follow up 36 months after intervention)
- Blood lipids(At follow up 36 months after intervention.)
- WHODAS 2.0 (World health organization disability assessment schedule)(At follow up 36 months after intervention.)
- CGI-S (Clinical Global Impressions - Severity Scale)(At follow up 36 months after intervention)
- EQ-5D-5L (EuroQol VAS)(At follow up 36 months after intervention.)
- Blood pressure(At follow up 36 months after intervention)
- FBS (fasting blood sugar)(At follow up 36 months after intervention.)
- CRP (C-reactive protein)(At follow up 36 months after intervention.)
- AS-18 (Affective self rating scale)(At follow up 36 months after intervention.)
- Heart rate(At follow up 36 months after intervention)
- BMI (Body mass index)(At follow up 36 months after intervention)
- Telomere length(At follow up 12 months after intervention.)
- SRH (Self-rated health)(At follow up 36 months after intervention.)
- 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.)
- YMRS (Young Ziegler Mania Rating Scale)(Change from inclusion to follow up 6 weeks after inclusion)
- YMRS (Young Ziegler Mania Rating Scale)(At follow up 12 months after intervention.)
- YMRS (Young Ziegler Mania Rating Scale)(At follow up 24 months after intervention.)
- CGI-S (Clinical Global Impressions - Severity Scale)(Change from inclusion to follow up 6 weeks after inclusion)
- CGI-S (Clinical Global Impressions - Severity Scale)(At follow up 12 months after intervention)
- CGI-S (Clinical Global Impressions - Severity Scale)(At follow up 24 months after intervention)
- Blood pressure(Change from inclusion to follow up 6 weeks after inclusion)
- Blood pressure(At follow up 12 months after intervention)
- Blood pressure(At follow up 24 months after intervention)
- Heart rate(Change from inclusion to follow up 6 weeks after inclusion)
- Heart rate(At follow up 12 months after intervention)
- Heart rate(At follow up 24 months after intervention)
- BMI (Body mass index)(Change from inclusion to follow up 6 weeks after inclusion)
- BMI (Body mass index)(At follow up 12 months after intervention)
- BMI (Body mass index)(At follow up 24 months after intervention)
- Waist circumference(Change from inclusion to follow up 6 weeks after inclusion)
- Waist circumference(At follow up 12 months after intervention)
- Waist circumference(At follow up 24 months after intervention)
- FBS (fasting blood sugar)(Change from inclusion to follow up 6 weeks after inclusion)
- FBS (fasting blood sugar)(At follow up 12 months after intervention.)
- FBS (fasting blood sugar)(At follow up 24 months after intervention.)
- HbA1c (Hemoglobin A1c)(Change from inclusion to follow up 6 weeks after inclusion)
- HbA1c (Hemoglobin A1c)(At follow up 12 months after intervention.)
- HbA1c (Hemoglobin A1c)(At follow up 24 months after intervention.)
- Blood lipids(Change from inclusion to follow up 6 weeks after inclusion)
- Blood lipids(At follow up 12 months after intervention.)
- Blood lipids(At follow up 24 months after intervention.)
- CRP (C-reactive protein)(Change from inclusion to follow up 6 weeks after inclusion)
- CRP (C-reactive protein)(At follow up 12 months after intervention.)
- CRP (C-reactive protein)(At follow up 24 months after intervention.)
- Telomere length(Change from inclusion to follow up 6 weeks after inclusion)
- Telomerase(Change from inclusion to follow up 6 weeks after inclusion)
- WHODAS 2.0 (World health organization disability assessment schedule)(Change from inclusion to follow up 6 weeks after inclusion)
- WHODAS 2.0 (World health organization disability assessment schedule)(At follow up 12 months after intervention.)
- WHODAS 2.0 (World health organization disability assessment schedule)(At follow up 24 months after intervention.)
- EQ-5D-5L (EuroQol VAS)(Change from inclusion to follow up 6 weeks after inclusion)
- EQ-5D-5L (EuroQol VAS)(At follow up 12 months after intervention.)
- EQ-5D-5L (EuroQol VAS)(At follow up 24 months after intervention.)
- SRH (Self-rated health)(Change from inclusion to follow up 6 weeks after inclusion)
- SRH (Self-rated health)(At follow up 12 months after intervention.)
- SRH (Self-rated health)(At follow up 24 months after intervention.)
- BBQ (Brunnsviken Brief Quality of Life Questionnaire)(Change from inclusion to follow up 6 weeks after inclusion)
- BBQ (Brunnsviken Brief Quality of Life Questionnaire)(At follow up 12 months after intervention.)
- BBQ (Brunnsviken Brief Quality of Life Questionnaire)(At follow up 24 months after intervention.)
- Occupational level measured in % of work ability in medical certificate(Change from inclusion to follow up 6 weeks after inclusion)
- Occupational level measured in % of work ability in medical certificate(At follow up 12 months after intervention.)
- Occupational level measured in % of work ability in medical certificate(At follow up 24 months after intervention.)