Bipolar DisorderNCT03353337
A Study of Aerobic Exercise for Patients With Bipolar Disorder
A study testing aerobic exercise in people with Bipolar Disorder and Cognitive Symptom, run by Guangzhou Psychiatric Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder, Cognitive Symptom
- What is being tested?
- aerobic exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2017to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- DSM-IV defined bipolar disorder.
- Never accept aerobic exercise therapy.
- dextromanuality.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Guangzhou Brain hospital(Guangzhou Huiai Hospital)
Guangzhou, Guangdong, 510370
Kangguang Lin, D.D;Ph.D, 13560360144, klin@connect.hku.hk
About this study
Official title: 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.
Read the 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.
- Conditions
- Bipolar Disorder, Cognitive Symptom
- Being tested
- aerobic exercise, Placebo controlled group
- Keywords
- neurocognition, prognosis, aerobic exercise
- Medical subject headings
- Bipolar Disorder, Neurobehavioral Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic exerciseBehavioural
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 groupBehavioural
General intensity activities of recreation therapy, including Handicraft manufacture, reading activity, singing entertainment, walking.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: aerobic exercise |
| Placebo controlled group | Placebo comparator | General intensity activities of recreation therapy, including Handicraft manufacture, reading activity, singing entertainment, walking. Receives: Behavioral: Placebo controlled group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in neurocognitive function
Changes in neurocognitive function measured by the MATRICS Consensus Cognitive Battery (MCCB) after three months (12 weeks) of aerobic exercise
Measured: 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
Measured: 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
Relapses of depressive and/or hypo/manic episodes
Measured: 12 months
depressive symptoms
depressive symptoms measured by Hamilton Depression Scale
Measured: 4 weeks, 4 months, 12 months
manic symptom
manic symptom measured by Young Manic Rating Scale
Measured: 4 weeks, 4 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2017
- Study start1 Dec 2017 (estimated)
- Primary completion31 Jul 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Psychiatric Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Kangguang Lin, Guangzhou Psychiatric Hospital
- Investigators
- Kangguang Lin, MD, PhD, Principal investigator, Guangzhou Brain hospital (Guangzhou Psychiatric Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03353337
- Sponsor's protocol ID
- GZ Psychiatric Hospital
- Status last verified
- Nov 2017
- First submitted
- 21 Nov 2017
- Last updated
- 27 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of Aerobic Exercise for Inpatients With Bipolar Affective Disorder
- ClinicalTrials.gov ID
- NCT03353337
- Acronym / sponsor ID
- GZ Psychiatric Hospital
- Conditions
- Bipolar Disorder, Cognitive Symptom
- Keywords
- neurocognition, prognosis, aerobic exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Guangzhou Psychiatric HospitalOther government
- Study start
- 1 Dec 2017 (estimated)
- Primary completion
- 31 Jul 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 27 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aerobic exercise | Experimental | Behavioral: aerobic exerciseCycling 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. |
| Placebo controlled group | Placebo comparator | Behavioral: Placebo controlled groupGeneral intensity activities of recreation therapy, including Handicraft manufacture, reading activity, singing entertainment, walking. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- DSM-IV defined bipolar disorder.
- Never accept aerobic exercise therapy.
- dextromanuality.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aerobic exerciseCycling 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. | Behavioural | aerobic exercise |
| Placebo controlled groupGeneral intensity activities of recreation therapy, including Handicraft manufacture, reading activity, singing entertainment, walking. | Behavioural | Placebo controlled group |
Primary outcome
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
3 secondary outcomes
relapse rate
Time frame: 12 months
depressive symptoms
Time frame: 4 weeks, 4 months, 12 months
manic symptom
Time frame: 4 weeks, 4 months, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kangguang Lin, MD, PhD principal investigator
Guangzhou Brain hospital (Guangzhou Psychiatric Hospital)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aerobic exercise in people with Bipolar Disorder and Cognitive Symptom, run by Guangzhou Psychiatric Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kangguang Lin, MD, PhD (13560360144, klin@connect.hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in neurocognitive function (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2017.