A Study of Aerobic Exercise for Patients With Bipolar Disorder

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03353337
• Other study ID #: GZ Psychiatric Hospital
• Status: Not yet recruiting
• Phase: N/A
• First received: November 21, 2017
• Last updated: November 21, 2017
• Start date: December 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: November 2017
• Source: Guangzhou Psychiatric Hospital
• Contact: Kangguang Lin, MD, PhD
• Phone: 13560360144
• Email: klin[@]connect.hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 210
• Est. completion date: December 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Cognitive Symptom
• Disease
• Neurobehavioral Manifestations

Intervention

Behavioral:
• 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 months.
• Placebo controlled group
General intensity activities of recreation therapy, including Handicraft manufacture, reading activity, singing entertainment, walking.

Locations

Country	Name	City	State
China	Guangzhou Brain hospital(Guangzhou Huiai Hospital)	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Psychiatric Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	relapse rate	Relapses of depressive and/or hypo/manic episodes	12 months
Secondary	depressive symptoms	depressive symptoms measured by Hamilton Depression Scale	4 weeks, 4 months, 12 months
Secondary	manic symptom	manic symptom measured by Young Manic Rating Scale	4 weeks, 4 months, 12 months