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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03353337
Other study ID # GZ Psychiatric Hospital
Secondary ID
Status Not yet recruiting
Phase N/A
First received November 21, 2017
Last updated November 21, 2017
Start date December 1, 2017
Est. completion date December 31, 2019

Study information

Verified date November 2017
Source Guangzhou Psychiatric Hospital
Contact Kangguang Lin, MD, PhD
Phone 13560360144
Email klin@connect.hku.hk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 210
Est. completion date December 31, 2019
Est. primary completion date July 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
China Guangzhou Brain hospital(Guangzhou Huiai Hospital) Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Guangzhou Psychiatric Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 relapse rate Relapses of depressive and/or hypo/manic episodes 12 months
Secondary depressive symptoms depressive symptoms measured by Hamilton Depression Scale 4 weeks, 4 months, 12 months
Secondary manic symptom manic symptom measured by Young Manic Rating Scale 4 weeks, 4 months, 12 months
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