A Study of Aerobic Exercise for Patients With Bipolar Disorder

Sponsor

Guangzhou Psychiatric Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03353337

Collaborator

(none)

210

Enrollment

Location

Arms

Anticipated Duration (Months)

8.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bipolar Disorder Cognitive Symptom	Behavioral: aerobic exercise Behavioral: Placebo controlled group	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

210 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2017

Anticipated Primary Completion Date :

Jul 31, 2019

Anticipated Study Completion Date :

Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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 Comparator: Placebo controlled group General intensity activities of recreation therapy, including Handicraft manufacture, reading activity, singing entertainment, walking.	Behavioral: Placebo controlled group General intensity activities of recreation therapy, including Handicraft manufacture, reading activity, singing entertainment, walking.

Arm

Intervention/Treatment

Experimental: 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.

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 Comparator: Placebo controlled group

General intensity activities of recreation therapy, including Handicraft manufacture, reading activity, singing entertainment, walking.

Behavioral: Placebo controlled group

General intensity activities of recreation therapy, including Handicraft manufacture, reading activity, singing entertainment, walking.

Outcome Measures

Primary Outcome Measures

Changes in neurocognitive function [12 months]
Changes in neurocognitive function measured by the MATRICS Consensus Cognitive Battery (MCCB) after three months (12 weeks) of aerobic exercise
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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Guangzhou Brain hospital(Guangzhou Huiai Hospital)	Guangzhou	Guangdong	China	510370

Sponsors and Collaborators

Guangzhou Psychiatric Hospital

Investigators

Principal Investigator: Kangguang Lin, MD, PhD, Guangzhou Brain hospital (Guangzhou Psychiatric Hospital)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kangguang Lin, MD,PhD, Guangzhou Psychiatric Hospital

ClinicalTrials.gov Identifier:

NCT03353337

Other Study ID Numbers:

GZ Psychiatric Hospital

First Posted:

Nov 27, 2017

Last Update Posted:

Nov 27, 2017

Last Verified:

Nov 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Kangguang Lin, MD,PhD, Guangzhou Psychiatric Hospital

neurocognition

prognosis

aerobic exercise

Additional relevant MeSH terms:

Neurobehavioral Manifestations

Bipolar Disorder

Study Results

No Results Posted as of Nov 27, 2017