Braining- Aerobic Physical Activity as Add on Treatment in Bipolar Depression

Bipolar Disorder Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05340686
• Other study ID #: Braining Bipolar RCT
• Status: Recruiting
• Phase: N/A
• Start date: October 26, 2022
• Est. completion date: April 20, 2027

Study information

• Verified date: July 2023
• Source: Region Stockholm
• Contact: Åsa Anger, MD
• Phone: +46858580445
• Email: asa.susanna.anger[@]ki.se
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: April 20, 2027
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar Depression
• Bipolar Disorder
• Bipolar I Disorder
• Bipolar II Disorder
• Depression
• Depressive Disorder
• Genetic Diseases, X-Linked
• Mood Disorders

Intervention

Behavioral:
• Aerobic Physical Exercise
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 Exercise
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 exercise
Written and oral information about physical exercise recommendations, on one occasion, by researcher

Locations

Country	Name	City	State
Sweden	Region Stockholm, Psykiatri Sydväst (Psychiatric Clinic Psychiatry Southwest)	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Region Stockholm	Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.
Primary	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.
Primary	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	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.	Change from inclusion to follow up 6 weeks after inclusion
Secondary	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.	Change from inclusion to follow up 6 weeks after inclusion
Secondary	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.	At follow up 12 months after intervention.
Secondary	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.	At follow up 24 months after intervention.
Secondary	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.	At follow up 36 months after intervention.
Secondary	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.	Change from inclusion to follow up 6 weeks after inclusion
Secondary	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.	At follow up 12 months after intervention.
Secondary	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.	At follow up 24 months after intervention.
Secondary	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.	At follow up 36 months after intervention.
Secondary	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?".	Change from inclusion to follow up 6 weeks after inclusion
Secondary	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?".	At follow up 12 months after intervention
Secondary	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?".	At follow up 24 months after intervention
Secondary	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?".	At follow up 36 months after intervention
Secondary	Blood pressure	systolic and diastolic, mmHg	Change from inclusion to follow up 6 weeks after inclusion
Secondary	Blood pressure	systolic and diastolic, mmHg	At follow up 12 months after intervention
Secondary	Blood pressure	systolic and diastolic, mmHg	At follow up 24 months after intervention
Secondary	Blood pressure	systolic and diastolic, mmHg	At follow up 36 months after intervention
Secondary	Heart rate	Heart rate, beats per minute	Change from inclusion to follow up 6 weeks after inclusion
Secondary	Heart rate	Heart rate, beats per minute	At follow up 12 months after intervention
Secondary	Heart rate	Heart rate, beats per minute	At follow up 24 months after intervention
Secondary	Heart rate	Heart rate, beats per minute	At follow up 36 months after intervention
Secondary	BMI (Body mass index)	Weight in kg divided by the square of height in m	Change from inclusion to follow up 6 weeks after inclusion
Secondary	BMI (Body mass index)	Weight in kg divided by the square of height in m	At follow up 12 months after intervention
Secondary	BMI (Body mass index)	Weight in kg divided by the square of height in m	At follow up 24 months after intervention
Secondary	BMI (Body mass index)	Weight in kg divided by the square of height in m	At follow up 36 months after intervention
Secondary	Waist circumference	Waist circumference, cm	Change from inclusion to follow up 6 weeks after inclusion
Secondary	Waist circumference	Waist circumference, cm	At follow up 12 months after intervention
Secondary	Waist circumference	Waist circumference, cm	At follow up 24 months after intervention
Secondary	Waist circumference	Waist circumference, cm	At follow up 36 months after intervention
Secondary	FBS (fasting blood sugar)	fasting blood sugar, mmol/l	Change from inclusion to follow up 6 weeks after inclusion
Secondary	FBS (fasting blood sugar)	fasting blood sugar, mmol/l	At follow up 12 months after intervention.
Secondary	FBS (fasting blood sugar)	fasting blood sugar, mmol/l	At follow up 24 months after intervention.
Secondary	FBS (fasting blood sugar)	fasting blood sugar, mmol/l	At follow up 36 months after intervention.
Secondary	HbA1c (Hemoglobin A1c)	Glycated hemoglobin, mmol/mol	Change from inclusion to follow up 6 weeks after inclusion
Secondary	HbA1c (Hemoglobin A1c)	Glycated hemoglobin, mmol/mol	At follow up 12 months after intervention.
Secondary	HbA1c (Hemoglobin A1c)	Glycated hemoglobin, mmol/mol	At follow up 24 months after intervention.
Secondary	HbA1c (Hemoglobin A1c)	Glycated hemoglobin, mmol/mol	At follow up 36 months after intervention.
Secondary	Blood lipids	Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, mmol/L	Change from inclusion to follow up 6 weeks after inclusion
Secondary	Blood lipids	Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, mmol/L	At follow up 12 months after intervention.
Secondary	Blood lipids	Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, mmol/L	At follow up 24 months after intervention.
Secondary	Blood lipids	Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, mmol/L	At follow up 36 months after intervention.
Secondary	CRP (C-reactive protein)	Measurement of inflammation and infection, mmol/L	Change from inclusion to follow up 6 weeks after inclusion
Secondary	CRP (C-reactive protein)	Measurement of inflammation and infection, mmol/L	At follow up 12 months after intervention.
Secondary	CRP (C-reactive protein)	Measurement of inflammation and infection, mmol/L	At follow up 24 months after intervention.
Secondary	CRP (C-reactive protein)	Measurement of inflammation and infection, mmol/L	At follow up 36 months after intervention.
Secondary	Telomere length	telomere length in leukocytes	Change from inclusion to follow up 6 weeks after inclusion
Secondary	Telomere length	telomere length in leukocytes	At follow up 12 months after intervention.
Secondary	Telomerase	Enzyme activity in blood	Change from inclusion to follow up 6 weeks after inclusion
Secondary	Telomerase	Enzyme activity in blood	At follow up 12 months after intervention.
Secondary	WHODAS 2.0 (World health organization disability assessment schedule)	Self rated disability. Minimum value 0, maximum value 100, where higher values indicate more disability.	Change from inclusion to follow up 6 weeks after inclusion
Secondary	WHODAS 2.0 (World health organization disability assessment schedule)	Self rated disability. Minimum value 0, maximum value 100, where higher values indicate more disability.	At follow up 12 months after intervention.
Secondary	WHODAS 2.0 (World health organization disability assessment schedule)	Self rated disability. Minimum value 0, maximum value 100, where higher values indicate more disability.	At follow up 24 months after intervention.
Secondary	WHODAS 2.0 (World health organization disability assessment schedule)	Self rated disability. Minimum value 0, maximum value 100, where higher values indicate more disability.	At follow up 36 months after intervention.
Secondary	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.	Change from inclusion to follow up 6 weeks after inclusion
Secondary	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.	At follow up 12 months after intervention.
Secondary	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.	At follow up 24 months after intervention.
Secondary	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.	At follow up 36 months after intervention.
Secondary	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."	Change from inclusion to follow up 6 weeks after inclusion
Secondary	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."	At follow up 12 months after intervention.
Secondary	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."	At follow up 24 months after intervention.
Secondary	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."	At follow up 36 months after intervention.
Secondary	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.	Change from inclusion to follow up 6 weeks after inclusion
Secondary	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.	At follow up 12 months after intervention.
Secondary	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.	At follow up 24 months after intervention.
Secondary	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.	At follow up 36 months after intervention.
Secondary	Occupational level measured in % of work ability in medical certificate	Complete sick leave 0%, partial sick leave 25-75 %, completely able to work 100%.	Change from inclusion to follow up 6 weeks after inclusion
Secondary	Occupational level measured in % of work ability in medical certificate	Complete sick leave 0%, partial sick leave 25-75 %, completely able to work 100%.	At follow up 12 months after intervention.
Secondary	Occupational level measured in % of work ability in medical certificate	Complete sick leave 0%, partial sick leave 25-75 %, completely able to work 100%.	At follow up 24 months after intervention.
Secondary	Occupational level measured in % of work ability in medical certificate	Complete sick leave 0%, partial sick leave 25-75 %, completely able to work 100%.	At follow up 36 months after intervention.