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A Study of Aerobic Exercise for Patients With Bipolar Disorder

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ClinicalTrials.gov Identifier: NCT03353337
Recruitment Status : Not yet recruiting
First Posted : November 27, 2017
Last Update Posted : November 27, 2017
Sponsor:
Information provided by (Responsible Party):

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
Bipolar Disorder Cognitive Symptom Behavioral: aerobic exercise Behavioral: Placebo controlled group

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  (Clinical Trial)
Estimated 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 : December 1, 2017
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.


Outcome Measures

Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. relapse rate [ Time Frame: 12 months ]
    Relapses of depressive and/or hypo/manic episodes

  2. depressive symptoms [ Time Frame: 4 weeks, 4 months, 12 months ]
    depressive symptoms measured by Hamilton Depression Scale

  3. manic symptom [ Time Frame: 4 weeks, 4 months, 12 months ]
    manic symptom measured by Young Manic Rating Scale


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03353337


Contacts
Contact: Kangguang Lin, MD, PhD 13560360144 klin@connect.hku.hk
Contact: Yaoguang Guo, MPH 13580339565 365252574@qq.com

Locations
China, Guangdong
Guangzhou Brain hospital(Guangzhou Huiai Hospital) Recruiting
Guangzhou, Guangdong, China, 510370
Contact: Kangguang Lin, D.D;Ph.D    13560360144    klin@connect.hku.hk   
Sponsors and Collaborators
Guangzhou Psychiatric Hospital
Investigators
Principal Investigator: Kangguang Lin, MD, PhD Guangzhou Brain hospital (Guangzhou Psychiatric Hospital)
More Information

Responsible Party: Kangguang Lin, MD,PhD, Guangzhou Psychiatric Hospital
ClinicalTrials.gov Identifier: NCT03353337     History of Changes
Other Study ID Numbers: GZ Psychiatric Hospital
First Posted: November 27, 2017    Key Record Dates
Last Update Posted: November 27, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kangguang Lin, Guangzhou Psychiatric Hospital:
neurocognition
prognosis
aerobic exercise

Additional relevant MeSH terms:
Disease
Bipolar Disorder
Neurobehavioral Manifestations
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms