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A Study of Aerobic Exercise for Patients With Bipolar Disorder

Primary Purpose

Bipolar Disorder, Cognitive Symptom

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
aerobic exercise
Placebo controlled group
Sponsored by
Guangzhou Psychiatric Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring neurocognition, prognosis, aerobic exercise

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Guangzhou Brain hospital(Guangzhou Huiai Hospital)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

aerobic exercise

Placebo controlled group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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
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
Relapses of depressive and/or hypo/manic episodes
depressive symptoms
depressive symptoms measured by Hamilton Depression Scale
manic symptom
manic symptom measured by Young Manic Rating Scale

Full Information

First Posted
November 21, 2017
Last Updated
November 21, 2017
Sponsor
Guangzhou Psychiatric Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03353337
Brief Title
A Study of Aerobic Exercise for Patients With Bipolar Disorder
Official Title
A Randomised Controlled Trial of Aerobic Exercise for Inpatients With Bipolar Affective Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2017 (Anticipated)
Primary Completion Date
July 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou Psychiatric Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder, Cognitive Symptom
Keywords
neurocognition, prognosis, aerobic exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
aerobic exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo controlled group
Arm Type
Placebo Comparator
Arm Description
General intensity activities of recreation therapy, including Handicraft manufacture, reading activity, singing entertainment, walking.
Intervention Type
Behavioral
Intervention Name(s)
aerobic exercise
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Placebo controlled group
Intervention Description
General intensity activities of recreation therapy, including Handicraft manufacture, reading activity, singing entertainment, walking.
Primary Outcome Measure Information:
Title
Changes in neurocognitive function
Description
Changes in neurocognitive function measured by the MATRICS Consensus Cognitive Battery (MCCB) after three months (12 weeks) of aerobic exercise
Time Frame
12 months
Title
Changes in neurocognitive function
Description
Changes in neurocognitive function measured by the MATRICS Consensus Cognitive Battery (MCCB) after three months (12 weeks) of aerobic exercise
Time Frame
Changes in neurocognitive function measured by the MATRICS Consensus Cognitive Battery (MCCB) after three months (12 weeks) of aerobic exercise
Secondary Outcome Measure Information:
Title
relapse rate
Description
Relapses of depressive and/or hypo/manic episodes
Time Frame
12 months
Title
depressive symptoms
Description
depressive symptoms measured by Hamilton Depression Scale
Time Frame
4 weeks, 4 months, 12 months
Title
manic symptom
Description
manic symptom measured by Young Manic Rating Scale
Time Frame
4 weeks, 4 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kangguang Lin, MD, PhD
Phone
13560360144
Email
klin@connect.hku.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Yaoguang Guo, MPH
Phone
13580339565
Email
365252574@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kangguang Lin, MD, PhD
Organizational Affiliation
Guangzhou Brain hospital (Guangzhou Psychiatric Hospital)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangzhou Brain hospital(Guangzhou Huiai Hospital)
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510370
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kangguang Lin, D.D;Ph.D
Phone
13560360144
Email
klin@connect.hku.hk

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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A Study of Aerobic Exercise for Patients With Bipolar Disorder

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