A Study of Aerobic Exercise for Patients With Bipolar Disorder

November 21, 2017 updated by: Kangguang Lin, Guangzhou Psychiatric Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

210

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510370
        • Guangzhou Brain hospital(Guangzhou Huiai Hospital)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in neurocognitive function
Time Frame: 12 months
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
Time Frame: 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
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
Time Frame: 12 months
Relapses of depressive and/or hypo/manic episodes
12 months
depressive symptoms
Time Frame: 4 weeks, 4 months, 12 months
depressive symptoms measured by Hamilton Depression Scale
4 weeks, 4 months, 12 months
manic symptom
Time Frame: 4 weeks, 4 months, 12 months
manic symptom measured by Young Manic Rating Scale
4 weeks, 4 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou Psychiatric Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2017

Primary Completion (Anticipated)

July 31, 2019

Study Completion (Anticipated)

December 31, 2019

Study Registration Dates

First Submitted

November 21, 2017

First Submitted That Met QC Criteria

November 21, 2017

First Posted (Actual)

November 27, 2017

Study Record Updates

Last Update Posted (Actual)

November 27, 2017

Last Update Submitted That Met QC Criteria

November 21, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GZ Psychiatric Hospital

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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