A Study of Aerobic Exercise for Patients With Bipolar Disorder

Not Applicable

• Conditions: Bipolar Disorder; Cognitive Symptom
• Interventions: Behavioral: aerobic exercise; Behavioral: Placebo controlled group

• Registration Number: NCT03353337
• Lead Sponsor: Guangzhou Psychiatric Hospital

Brief Summary

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

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.

Study Timeline

• Status Verified: 2017-11
• Study First Submitted: 2017-11-21
• Study First Submitted QC: 2017-11-21
• Last Update Submitted: 2017-11-21
• Study First Posted: 2017-11-27
• Last Update Posted: 2017-11-27
• Study Start: 2017-12-01
• Primary Completion: 2019-07-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 210

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
aerobic exercise	aerobic exercise	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.
Placebo controlled group	Placebo controlled group	General intensity activities of recreation therapy, including Handicraft manufacture, reading activity, singing entertainment, walking.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
depressive symptoms	4 weeks, 4 months, 12 months	depressive symptoms measured by Hamilton Depression Scale
relapse rate	12 months	Relapses of depressive and/or hypo/manic episodes
manic symptom	4 weeks, 4 months, 12 months	manic symptom measured by Young Manic Rating Scale

Trial Locations

Locations (1)

Guangzhou Brain hospital(Guangzhou Huiai Hospital); 🇨🇳 Guangzhou, Guangdong, China