ClinicalTrials.gg
Status unknownNCT03353337Updated Nov 27, 2017

A Study of Aerobic Exercise for Patients With Bipolar Disorder

An interventional study of aerobic exercise and Placebo controlled group in Bipolar Disorder and Cognitive Symptom, sponsored by Guangzhou Psychiatric Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-27.

Sponsored by Guangzhou Psychiatric Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2017), so the status shown — last known as Not yet recruiting — may be out of date.

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Phase
Not applicable
Study type
Interventional
Enrollment
210
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 78 studies in Bipolar Disorder with a site in China — 31 open to participants now, 31 under way, 1 of them phase 3. Bipolar Disorder · China.

Planned enrollment
17th of 50
210 · median 126
Started
2017
with 3 others
No phase
30 of 78
15 open now
Registered
26th of 78
by date
Lead sponsor
3 of 78
Guangzhou Psychiatric Hospital

Among the 78 studies in Bipolar Disorder with a site in China, this one is the 17th largest by planned enrollment of the 50 interventional ones that give a count, is one of 4 that started in 2017, is one of 30 with no phase, and was the 26th registered.

Bipolar Disorder

1,684 studies on the registry are indexed under Bipolar Disorder; 267 are open to participants now.

Browse Bipolar Disorder studies →

Open to participants now

31 of the 78 studies in Bipolar Disorder with a site in China are open now. Recruiting first, the newest first:

26 more — sign in →

All 31 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 205 Bipolar Disorder studies recruiting now, 59 (29%) set no upper age limit and 134 (65%) stop at 75 or younger; 37 take children under 18; 50 take healthy volunteers.

This study: 18 Years to 60 Years · all sexes · healthy volunteers too.

The full table on the hub →

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02

Study 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 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.

03

Conditions studied

  • Bipolar Disorder
  • Cognitive Symptom

Keywords

  • neurocognition
  • prognosis
  • aerobic exercise
04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • defined bipolar disorder.
  • Never accept aerobic exercise therapy.
  • dextromanuality.

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
210 participants (estimated)

Study arms

  • Experimental
    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.

    Behavioral: aerobic exercise

  • Placebo comparator
    Placebo controlled group

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

    Behavioral: Placebo controlled group

Interventions

  • Behavioralaerobic 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.

  • BehavioralPlacebo controlled group

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

06

What researchers measure

Primary outcomes

  1. Changes in neurocognitive function

    Changes in neurocognitive function measured by the MATRICS Consensus Cognitive Battery (MCCB) after three months (12 weeks) of aerobic exercise

    Time frame: 12 months

  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

    Time frame: Changes in neurocognitive function measured by the MATRICS Consensus Cognitive Battery (MCCB) after three months (12 weeks) of aerobic exercise

Secondary outcomes

  1. relapse rate

    Relapses of depressive and/or hypo/manic episodes

    Time frame: 12 months

  2. depressive symptoms

    depressive symptoms measured by Hamilton Depression Scale

    Time frame: 4 weeks, 4 months, 12 months

  3. manic symptom

    manic symptom measured by Young Manic Rating Scale

    Time frame: 4 weeks, 4 months, 12 months

07

Study locations

1 site
  • Guangzhou Brain hospital(Guangzhou Huiai Hospital)
    Guangzhou, Guangdong 510370, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2017; primary completion for Jul 2019, 19 months later.

Of 354 non-industry interventional studies with no phase under Bipolar Disorder, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 58. This study's planned 19 months is below that.

Counting every sponsor, half of 356 studies reached it within 37 months; a quarter within 23 and three quarters within 58.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 21, 2017
First posted
Nov 27, 2017
StartEst.
Dec 1, 2017
Primary completionEst.
Jul 31, 2019
CompletionEst.
Dec 31, 2019
Last update
Nov 27, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 27, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03353337
Lead sponsor
Guangzhou Psychiatric Hospital
Responsible party
Kangguang Lin (MD,PhD, Guangzhou Psychiatric Hospital) — Principal investigator
First posted
Nov 27, 2017
Start date
Dec 1, 2017 (estimated)
Primary completion
Jul 31, 2019 (estimated)
Completion
Dec 31, 2019 (estimated)
Last update
Nov 27, 2017

Study contacts

Kangguang Lin, MD, PhD
Contact
klin@connect.hku.hk
13560360144
Yaoguang Guo, MPH
Contact
365252574@qq.com
13580339565
Kangguang Lin, MD, PhD
principal investigator · Guangzhou Brain hospital (Guangzhou Psychiatric Hospital)

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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