A Study of Aerobic Exercise for Patients With Bipolar Disorder

Study Overview
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Brief Summary
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This study will investigate the effects of aerobic exercise on mental states, cognition, BDNF, and long-term outcomes in patients with bipolar disorder.

Detailed Description
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Multiple cognitive impairments are common in patients with bipolar disorder. Preliminary evidence shows that aerobic exercise might have positive effects in enhancing cognition and improving clinical symptoms in patients with mood disorders. This randomized controlled trial will investigate short-term (1 months) effects of aerobic exercise on cognition and clinical symptoms as well as the long-term (12 months) effects on decreasing the recurrence rate.

Official Title
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A Randomised Controlled Trial of Aerobic Exercise for Inpatients With Bipolar Affective Disorder

Conditions
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Bipolar Disorder, Cognitive Symptom

Intervention / Treatment
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* Behavioral: aerobic exercise
* Behavioral: Placebo controlled group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: DSM-IV defined bipolar disorder. Never accept aerobic exercise therapy. dextromanuality. Exclusion Criteria: Diagnosed neurological or musculoskeletal disorder/injury, Uncontrolled cardiovascular or metabolic diseases that are not suitable for running Diagnosed hypertension Other diagnosed serious medical conditions that are not suitable for cycling Severe suicidal ideation Mental retardation Currently participating in a exercise program or activity, defined as 30 minutes of vigorous physical activity 4-5 times per week

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: aerobic exercise<br>Cycling at the intensity of 50%-70% of maximum heart rate (220-age) for 30 mins per day, 4 days per week, last for 1 month. | Behavioral: aerobic exercise<br>* Cycling at the intensity of 50%-70% of maximum heart rate (220-age) for 30 mins per day, 4 days per week, last for 1 months.<br>|
| Placebo Comparator: Placebo controlled group<br>General intensity activities of recreation therapy, including Handicraft manufacture, reading activity, singing entertainment, walking. | Behavioral: Placebo controlled group<br>* General intensity activities of recreation therapy, including Handicraft manufacture, reading activity, singing entertainment, walking.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in neurocognitive function | Changes in neurocognitive function measured by the MATRICS Consensus Cognitive Battery (MCCB) after three months (12 weeks) of aerobic exercise | 12 months | 
| Changes in neurocognitive function | Changes in neurocognitive function measured by the MATRICS Consensus Cognitive Battery (MCCB) after three months (12 weeks) of aerobic exercise | Changes in neurocognitive function measured by the MATRICS Consensus Cognitive Battery (MCCB) after three months (12 weeks) of aerobic exercise | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relapse rate | Relapses of depressive and/or hypo/manic episodes | 12 months | 
| depressive symptoms | depressive symptoms measured by Hamilton Depression Scale | 4 weeks, 4 months, 12 months | 
| manic symptom | manic symptom measured by Young Manic Rating Scale | 4 weeks, 4 months, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neurocognition, prognosis, aerobic exercise