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

NCT ID: NCT05340686

Last Updated: 2024-10-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-26
• Study Completion Date: 2027-04-20

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.

Conditions

Bipolar Disorder; Bipolar Depression; Bipolar I Disorder; Bipolar II Disorder; Bipolar Affective Disorder; Remission in; Bipolar Affective Disorder, Currently Depressed, Moderate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Braining high intensity

Moderate to vigorous physical exercise, supervised by psychiatric staff 3 times per week

Group Type: EXPERIMENTAL

Aerobic Physical Exercise

Intervention Type: BEHAVIORAL

Moderate to vigorous physical exercise 30-45 minutes in a group setting led by psychiatric staff, 3 times per week for 6 weeks

Braining relaxing exercise

Relaxation, light yoga or stretching exercise, supervised by psychiatric staff 3 times per week

Group Type: ACTIVE_COMPARATOR

Relaxing Physical Exercise

Intervention Type: BEHAVIORAL

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 health benefits from physical exercise, provided by researcher on one occasion.

Group Type: ACTIVE_COMPARATOR

Information about physical exercise

Intervention Type: BEHAVIORAL

Written and oral information about physical exercise recommendations, on one occasion, by researcher

Interventions

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

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

Information about physical exercise

Written and oral information about physical exercise recommendations, on one occasion, by researcher

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: collaborator

Region Stockholm

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lina Martinsson, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Region Stockholm, Psykiatri Sydväst (Psychiatric Clinic Psychiatry Southwest)

Stockholm, Stockholm County, Sweden

Countries

Sweden

Other Identifiers

Braining Bipolar RCT

Identifier Type: -

Identifier Source: org_study_id