A Randomised Controlled Trial of Aerobic Exercise for Inpatients With Bipolar Affective Disorder
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 210
- Locations
- 1
- Primary Endpoint
- Changes in neurocognitive function
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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: aerobic exercise (Behavioral)
Placebo controlled group
General intensity activities of recreation therapy, including Handicraft manufacture, reading activity, singing entertainment, walking.
Intervention: Placebo controlled group (Behavioral)
Outcomes
Primary Outcomes
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 Outcomes
- relapse rate(12 months)
- depressive symptoms(4 weeks, 4 months, 12 months)
- manic symptom(4 weeks, 4 months, 12 months)
Investigators
Kangguang Lin
MD,PhD
Guangzhou Psychiatric Hospital