Clinical trial NCT05340686: Braining- Aerobic Physical Activity As Add on Treatment in Bipolar Depression
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Lead sponsor: Region Stockholm
Sponsor class: OTHER_GOV
Collaborators: name: Karolinska Institutet
First posted: 2022-04-22
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: PHQ-9 (Patient Health Questionnaire - 9 items)
timeFrame: Change from inclusion to follow up 6 weeks after inclusion
measure: PHQ-9 (Patient Health Questionnaire - 9 items)
timeFrame: At follow up 12 months after intervention.
measure: PHQ-9 (Patient Health Questionnaire - 9 items)
timeFrame: At follow up 24 months after intervention.
measure: PHQ-9 (Patient Health Questionnaire - 9 items)
timeFrame: At follow up 36 months after intervention.
Secondary outcomes:
measure: MADRS (Montgomery-Åsberg Depression Rating Scale)
timeFrame: Change from inclusion to follow up 6 weeks after inclusion
measure: AS-18 (Affective self rating scale)
timeFrame: Change from inclusion to follow up 6 weeks after inclusion
measure: AS-18 (Affective self rating scale)
timeFrame: At follow up 12 months after intervention.
measure: AS-18 (Affective self rating scale)
timeFrame: At follow up 24 months after intervention.
measure: AS-18 (Affective self rating scale)
timeFrame: At follow up 36 months after intervention.
measure: YMRS (Young Ziegler Mania Rating Scale)
timeFrame: Change from inclusion to follow up 6 weeks after inclusion
measure: YMRS (Young Ziegler Mania Rating Scale)
timeFrame: At follow up 12 months after intervention.
measure: YMRS (Young Ziegler Mania Rating Scale)
timeFrame: At follow up 24 months after intervention.
measure: YMRS (Young Ziegler Mania Rating Scale)
timeFrame: At follow up 36 months after intervention.
measure: CGI-S (Clinical Global Impressions - Severity Scale)
timeFrame: Change from inclusion to follow up 6 weeks after inclusion
measure: CGI-S (Clinical Global Impressions - Severity Scale)
timeFrame: At follow up 12 months after intervention
measure: CGI-S (Clinical Global Impressions - Severity Scale)
timeFrame: At follow up 24 months after intervention
measure: CGI-S (Clinical Global Impressions - Severity Scale)
timeFrame: At follow up 36 months after intervention
measure: Blood pressure
timeFrame: Change from inclusion to follow up 6 weeks after inclusion
measure: Blood pressure
timeFrame: At follow up 12 months after intervention
measure: Blood pressure
timeFrame: At follow up 24 months after intervention
measure: Blood pressure
timeFrame: At follow up 36 months after intervention
measure: Heart rate
timeFrame: Change from inclusion to follow up 6 weeks after inclusion
measure: Heart rate
timeFrame: At follow up 12 months after intervention
measure: Heart rate
timeFrame: At follow up 24 months after intervention
measure: Heart rate
timeFrame: At follow up 36 months after intervention
measure: BMI (Body mass index)
timeFrame: Change from inclusion to follow up 6 weeks after inclusion
measure: BMI (Body mass index)
timeFrame: At follow up 12 months after intervention
measure: BMI (Body mass index)
timeFrame: At follow up 24 months after intervention
measure: BMI (Body mass index)
timeFrame: At follow up 36 months after intervention
measure: Waist circumference
timeFrame: Change from inclusion to follow up 6 weeks after inclusion
measure: Waist circumference
timeFrame: At follow up 12 months after intervention
measure: Waist circumference
timeFrame: At follow up 24 months after intervention
measure: Waist circumference
timeFrame: At follow up 36 months after intervention
measure: FBS (fasting blood sugar)
timeFrame: Change from inclusion to follow up 6 weeks after inclusion
measure: FBS (fasting blood sugar)
timeFrame: At follow up 12 months after intervention.
measure: FBS (fasting blood sugar)
timeFrame: At follow up 24 months after intervention.
measure: FBS (fasting blood sugar)
timeFrame: At follow up 36 months after intervention.
measure: HbA1c (Hemoglobin A1c)
timeFrame: Change from inclusion to follow up 6 weeks after inclusion
measure: HbA1c (Hemoglobin A1c)
timeFrame: At follow up 12 months after intervention.
measure: HbA1c (Hemoglobin A1c)
timeFrame: At follow up 24 months after intervention.
measure: HbA1c (Hemoglobin A1c)
timeFrame: At follow up 36 months after intervention.
measure: Blood lipids
timeFrame: Change from inclusion to follow up 6 weeks after inclusion
measure: Blood lipids
timeFrame: At follow up 12 months after intervention.
measure: Blood lipids
timeFrame: At follow up 24 months after intervention.
measure: Blood lipids
timeFrame: At follow up 36 months after intervention.
measure: CRP (C-reactive protein)
timeFrame: Change from inclusion to follow up 6 weeks after inclusion
measure: CRP (C-reactive protein)
timeFrame: At follow up 12 months after intervention.
measure: CRP (C-reactive protein)
timeFrame: At follow up 24 months after intervention.
measure: CRP (C-reactive protein)
timeFrame: At follow up 36 months after intervention.
measure: Telomere length
timeFrame: Change from inclusion to follow up 6 weeks after inclusion
measure: Telomere length
timeFrame: At follow up 12 months after intervention.
measure: Telomerase
timeFrame: Change from inclusion to follow up 6 weeks after inclusion
measure: Telomerase
timeFrame: At follow up 12 months after intervention.
measure: WHODAS 2.0 (World health organization disability assessment schedule)
timeFrame: Change from inclusion to follow up 6 weeks after inclusion
measure: WHODAS 2.0 (World health organization disability assessment schedule)
timeFrame: At follow up 12 months after intervention.
measure: WHODAS 2.0 (World health organization disability assessment schedule)
timeFrame: At follow up 24 months after intervention.
measure: WHODAS 2.0 (World health organization disability assessment schedule)
timeFrame: At follow up 36 months after intervention.
measure: EQ-5D-5L (EuroQol VAS)
timeFrame: Change from inclusion to follow up 6 weeks after inclusion
measure: EQ-5D-5L (EuroQol VAS)
timeFrame: At follow up 12 months after intervention.
measure: EQ-5D-5L (EuroQol VAS)
timeFrame: At follow up 24 months after intervention.
measure: EQ-5D-5L (EuroQol VAS)
timeFrame: At follow up 36 months after intervention.
measure: SRH (Self-rated health)
timeFrame: Change from inclusion to follow up 6 weeks after inclusion
measure: SRH (Self-rated health)
timeFrame: At follow up 12 months after intervention.
measure: SRH (Self-rated health)
timeFrame: At follow up 24 months after intervention.
measure: SRH (Self-rated health)
timeFrame: At follow up 36 months after intervention.
measure: BBQ (Brunnsviken Brief Quality of Life Questionnaire)
timeFrame: Change from inclusion to follow up 6 weeks after inclusion
measure: BBQ (Brunnsviken Brief Quality of Life Questionnaire)
timeFrame: At follow up 12 months after intervention.
measure: BBQ (Brunnsviken Brief Quality of Life Questionnaire)
timeFrame: At follow up 24 months after intervention.
measure: BBQ (Brunnsviken Brief Quality of Life Questionnaire)
timeFrame: At follow up 36 months after intervention.
measure: Occupational level measured in % of work ability in medical certificate
timeFrame: Change from inclusion to follow up 6 weeks after inclusion
measure: Occupational level measured in % of work ability in medical certificate
timeFrame: At follow up 12 months after intervention.
measure: Occupational level measured in % of work ability in medical certificate
timeFrame: At follow up 24 months after intervention.
measure: Occupational level measured in % of work ability in medical certificate
timeFrame: At follow up 36 months after intervention.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Region Stockholm, Psykiatri Sydväst (Psychiatric Clinic Psychiatry Southwest)
Study officials:
affiliation: Karolinska Institutet
name: Lina Martinsson, PhD
role: PRINCIPAL_INVESTIGATOR
References: