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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):
Kangguang Lin, Guangzhou Psychiatric Hospital

November 21, 2017
November 27, 2017
November 27, 2017
December 1, 2017
July 31, 2019   (Final data collection date for primary outcome measure)
  • 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
  • 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
Same as current
No Changes Posted
  • relapse rate [ Time Frame: 12 months ]
    Relapses of depressive and/or hypo/manic episodes
  • depressive symptoms [ Time Frame: 4 weeks, 4 months, 12 months ]
    depressive symptoms measured by Hamilton Depression Scale
  • manic symptom [ Time Frame: 4 weeks, 4 months, 12 months ]
    manic symptom measured by Young Manic Rating Scale
Same as current
Not Provided
Not Provided
 
A Study of Aerobic Exercise for Patients With Bipolar Disorder
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.
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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Bipolar Disorder
  • Cognitive Symptom
  • 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.
  • Behavioral: Placebo controlled group
    General intensity activities of recreation therapy, including Handicraft manufacture, reading activity, singing entertainment, walking.
  • 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.
    Intervention: Behavioral: aerobic exercise
  • Placebo Comparator: Placebo controlled group
    General intensity activities of recreation therapy, including Handicraft manufacture, reading activity, singing entertainment, walking.
    Intervention: Behavioral: Placebo controlled group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
210
Same as current
December 31, 2019
July 31, 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
Yes
Contact: Kangguang Lin, MD, PhD 13560360144 klin@connect.hku.hk
Contact: Yaoguang Guo, MPH 13580339565 365252574@qq.com
China
 
 
NCT03353337
GZ Psychiatric Hospital
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
Kangguang Lin, Guangzhou Psychiatric Hospital
Guangzhou Psychiatric Hospital
Not Provided
Principal Investigator: Kangguang Lin, MD, PhD Guangzhou Brain hospital (Guangzhou Psychiatric Hospital)
Guangzhou Psychiatric Hospital
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP