Bipolar Affective Disorder, Currently Depressed, Moderate, Bipolar Affective Disorder; Remission in, Bipolar Depression, Bipolar Disorder, Bipolar I Disorder, Bipolar II Disorder
Conditions
Keywords
physical exercise, physical activity
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.
Interventions
BEHAVIORALAerobic 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
BEHAVIORALRelaxing 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
BEHAVIORALInformation about physical exercise
Written and oral information about physical exercise recommendations, on one occasion, by researcher
Sponsors
Region Stockholm
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PHQ-9 (Patient Health Questionnaire - 9 items) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MADRS (Montgomery-Åsberg Depression Rating Scale) | Change from inclusion to follow up 6 weeks after inclusion | 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. |
| AS-18 (Affective self rating scale) | Change from inclusion to follow up 6 weeks after inclusion | 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. |
| YMRS (Young Ziegler Mania Rating Scale) | Change from inclusion to follow up 6 weeks after inclusion | 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. |
| CGI-S (Clinical Global Impressions - Severity Scale) | Change from inclusion to follow up 6 weeks after inclusion | 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?". |
| Blood pressure | Change from inclusion to follow up 6 weeks after inclusion | systolic and diastolic, mmHg |
| Heart rate | Change from inclusion to follow up 6 weeks after inclusion | Heart rate, beats per minute |
| BMI (Body mass index) | Change from inclusion to follow up 6 weeks after inclusion | Weight in kg divided by the square of height in m |
| Waist circumference | Change from inclusion to follow up 6 weeks after inclusion | Waist circumference, cm |
| FBS (fasting blood sugar) | Change from inclusion to follow up 6 weeks after inclusion | fasting blood sugar, mmol/l |
| HbA1c (Hemoglobin A1c) | Change from inclusion to follow up 6 weeks after inclusion | Glycated hemoglobin, mmol/mol |
| Blood lipids | Change from inclusion to follow up 6 weeks after inclusion | Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, mmol/L |
| CRP (C-reactive protein) | Change from inclusion to follow up 6 weeks after inclusion | Measurement of inflammation and infection, mmol/L |
| Telomere length | Change from inclusion to follow up 6 weeks after inclusion | telomere length in leukocytes |
| Telomerase | Change from inclusion to follow up 6 weeks after inclusion | Enzyme activity in blood |
| WHODAS 2.0 (World health organization disability assessment schedule) | Change from inclusion to follow up 6 weeks after inclusion | Self rated disability. Minimum value 0, maximum value 100, where higher values indicate more disability. |
| EQ-5D-5L (EuroQol VAS) | Change from inclusion to follow up 6 weeks after inclusion | 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. |
| SRH (Self-rated health) | Change from inclusion to follow up 6 weeks after inclusion | 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." |
| BBQ (Brunnsviken Brief Quality of Life Questionnaire) | Change from inclusion to follow up 6 weeks after inclusion | Self rated quality of life. Minimum value 0, maximum value 96, where higher values indicate higher quality of life satisfaction. |
| Occupational level measured in % of work ability in medical certificate | Change from inclusion to follow up 6 weeks after inclusion | Complete sick leave 0%, partial sick leave 25-75 %, completely able to work 100%. |
Countries
Sweden
Contacts
PRINCIPAL_INVESTIGATORLina Martinsson, PhD
Karolinska Institutet
Outcome results
None listed