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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
54
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
Region Stockholm, Psykiatri Sydväst (Psychiatric Clinic Psychiatry Southwest)
Stockholm, Stockholm County, Sweden
PHQ-9 (Patient Health Questionnaire - 9 items)
Self rated depressive symptoms. Minimum value 0, maximum value 27, where higher values indicate more depressive symptoms.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At follow up 36 months after intervention.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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?".
Time frame: 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?".
Time frame: 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?".
Time frame: 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?".
Time frame: At follow up 36 months after intervention
Blood pressure
systolic and diastolic, mmHg
Time frame: Change from inclusion to follow up 6 weeks after inclusion
Blood pressure
systolic and diastolic, mmHg
Time frame: At follow up 12 months after intervention
Blood pressure
systolic and diastolic, mmHg
Time frame: At follow up 24 months after intervention
Blood pressure
systolic and diastolic, mmHg
Time frame: At follow up 36 months after intervention
Heart rate
Heart rate, beats per minute
Time frame: Change from inclusion to follow up 6 weeks after inclusion
Heart rate
Heart rate, beats per minute
Time frame: At follow up 12 months after intervention
Heart rate
Heart rate, beats per minute
Time frame: At follow up 24 months after intervention
Heart rate
Heart rate, beats per minute
Time frame: At follow up 36 months after intervention
BMI (Body mass index)
Weight in kg divided by the square of height in m
Time frame: 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
Time frame: At follow up 12 months after intervention
BMI (Body mass index)
Weight in kg divided by the square of height in m
Time frame: At follow up 24 months after intervention
BMI (Body mass index)
Weight in kg divided by the square of height in m
Time frame: At follow up 36 months after intervention
Waist circumference
Waist circumference, cm
Time frame: Change from inclusion to follow up 6 weeks after inclusion
Waist circumference
Waist circumference, cm
Time frame: At follow up 12 months after intervention
Waist circumference
Waist circumference, cm
Time frame: At follow up 24 months after intervention
Waist circumference
Waist circumference, cm
Time frame: At follow up 36 months after intervention
FBS (fasting blood sugar)
fasting blood sugar, mmol/l
Time frame: Change from inclusion to follow up 6 weeks after inclusion
FBS (fasting blood sugar)
fasting blood sugar, mmol/l
Time frame: At follow up 12 months after intervention.
FBS (fasting blood sugar)
fasting blood sugar, mmol/l
Time frame: At follow up 24 months after intervention.
FBS (fasting blood sugar)
fasting blood sugar, mmol/l
Time frame: At follow up 36 months after intervention.
HbA1c (Hemoglobin A1c)
Glycated hemoglobin, mmol/mol
Time frame: Change from inclusion to follow up 6 weeks after inclusion
HbA1c (Hemoglobin A1c)
Glycated hemoglobin, mmol/mol
Time frame: At follow up 12 months after intervention.
HbA1c (Hemoglobin A1c)
Glycated hemoglobin, mmol/mol
Time frame: At follow up 24 months after intervention.
HbA1c (Hemoglobin A1c)
Glycated hemoglobin, mmol/mol
Time frame: At follow up 36 months after intervention.
Blood lipids
Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, mmol/L
Time frame: Change from inclusion to follow up 6 weeks after inclusion
Blood lipids
Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, mmol/L
Time frame: At follow up 12 months after intervention.
Blood lipids
Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, mmol/L
Time frame: At follow up 24 months after intervention.
Blood lipids
Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, mmol/L
Time frame: At follow up 36 months after intervention.
CRP (C-reactive protein)
Measurement of inflammation and infection, mmol/L
Time frame: Change from inclusion to follow up 6 weeks after inclusion
CRP (C-reactive protein)
Measurement of inflammation and infection, mmol/L
Time frame: At follow up 12 months after intervention.
CRP (C-reactive protein)
Measurement of inflammation and infection, mmol/L
Time frame: At follow up 24 months after intervention.
CRP (C-reactive protein)
Measurement of inflammation and infection, mmol/L
Time frame: At follow up 36 months after intervention.
Telomere length
telomere length in leukocytes
Time frame: Change from inclusion to follow up 6 weeks after inclusion
Telomere length
telomere length in leukocytes
Time frame: At follow up 12 months after intervention.
Telomerase
Enzyme activity in blood
Time frame: Change from inclusion to follow up 6 weeks after inclusion
Telomerase
Enzyme activity in blood
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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."
Time frame: 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."
Time frame: 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."
Time frame: 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."
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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%.
Time frame: 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%.
Time frame: 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%.
Time frame: 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%.
Time frame: At follow up 36 months after intervention.
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