NCT03353337

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 27, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

November 27, 2017

Status Verified

November 1, 2017

Enrollment Period

1.7 years

First QC Date

November 21, 2017

Last Update Submit

November 21, 2017

Conditions

Bipolar DisorderCognitive Symptom

Keywords

neurocognitionprognosisaerobic exercise

Outcome Measures

Primary Outcomes (2)

  • Changes in neurocognitive function

    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

    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 Outcomes (3)

  • relapse rate

    12 months

  • depressive symptoms

    4 weeks, 4 months, 12 months

  • manic symptom

    4 weeks, 4 months, 12 months

Study Arms (2)

aerobic exercise

EXPERIMENTAL

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

Placebo controlled group

PLACEBO COMPARATOR

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

Behavioral: Placebo controlled group

Interventions

Placebo controlled groupBEHAVIORAL

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

Placebo controlled group
aerobic exerciseBEHAVIORAL

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.

aerobic exercise

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • DSM-IV defined bipolar disorder.
  • Never accept aerobic exercise therapy.
  • dextromanuality.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangzhou Brain hospital(Guangzhou Huiai Hospital)

Guangzhou, Guangdong, 510370, China

Location

MeSH Terms

Conditions

Bipolar DisorderNeurobehavioral Manifestations

Interventions

Exercise

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Kangguang Lin, MD, PhD

    Guangzhou Brain hospital (Guangzhou Psychiatric Hospital)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kangguang Lin, MD, PhD

CONTACT

13560360144klin@connect.hku.hk

Yaoguang Guo, MPH

CONTACT

13580339565365252574@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD,PhD

Study Record Dates

First Submitted

November 21, 2017

First Posted

November 27, 2017

Study Start

December 1, 2017

Primary Completion

July 31, 2019

Study Completion

December 31, 2019

Last Updated

November 27, 2017

Record last verified: 2017-11

Locations

CN(1)