Chronic Obstructive Pulmonary DiseaseNCT03892629
Baduanjin Exercise for Patients With GOLD 2-3 Stable COPD on Pulmonary Rehabilitation
A study testing Baduanjin exercise and Instrument rehabilitation in people with Chronic Obstructive Pulmonary Disease, run by ShuGuang Hospital at 1 site in China.
Trial summary
Chronic Obstructive Pulmonary Disease (COPD) is a disease with a very high morbidity and mortality rate. When the lung function drops lower and lower, patients will bear great affliction physically and mentally. How to improve the quality of life in patients with COPD is a hot topic in the study of COPD now. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Baduanjin exercise and Instrument rehabilitation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- Apr 2019to 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged from 40 to 80 years
- Diagnosed with stable chronic obstructive pulmonary disease
- Phase II~III
Who cannot join
- The condition was serious or movement restrained by other diseases
- In the acute exacerbation of chronic obstructive pulmonary disease
- Participants who have contraindications to exercise training
- Patients who have other serious acute, chronic organic disease or mental disorders
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Shuguang Hospital
Shanghai, 201203
Meng Sun, Master, 86-21-20256375, gulik002@aliyun.com
About this study
Official title: Baduanjin Exercise for Patients With GOLD 2-3 Stable Chronic Obstructive Pulmonary Disease on Pulmonary Rehabilitation: A Prospective, Randomized, Controlled Clinical Trial
Chronic Obstructive Pulmonary Disease (COPD) is a disease with a very high morbidity and mortality rate. When the lung function drops lower and lower, patients will bear great affliction physically and mentally. How to improve the quality of life in patients with COPD is a hot topic in the study of COPD now. Baduanjin, as one of the traditional Chinese qigong exercises, has the features of generous stretch, soft consistency, dynamic but static, which is an appropriate movement pattern for COPD patients.
Read the detailed description
To investigate the efficacy of Baduanjin exercise for patients with stable chronic obstructive pulmonary disease on phase II~III. A prospective, randomized, controlled clinical trial was designed.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Baduanjin exercise, Instrument rehabilitation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baduanjin exerciseBehavioural
Participants received Baduanjin exercise. Each Baduanjin exercise session lasts 30 minutes and continues twice a day, 5 times per week for 12 weeks
Instrument rehabilitationDevice
Participants received pulmanory rehabilitation by using tri-ball respiratory trainer. Each instrument exercise session lasts 30 minutes and continues twice a day, 5 times per week for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Baduanjin exercise group | Experimental | Participants in this group received Baduanjin exercise Receives: Behavioral: Baduanjin exercise |
| Instrument rehabilitation group | Active comparator | Participants in this group received rehabilitation by using tri-ball respiratory trainer Receives: Device: Instrument rehabilitation |
| Baduanjin Exercise and Instrument Rehabilitation | Active comparator | Participants in this group received both instrument rehabilitation and Baduanjin exercise Receives: Behavioral: Baduanjin exercise; Device: Instrument rehabilitation |
| No Intervention | No intervention | Participants in this group only received routine drug-treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
St. George's respiratory questionnaire (SGRQ)
Evaluating the changes of impact on quality of life
Measured: Baseline, 3 months, 6 months
Six-minute walk test (6MWT)
Testing patients changes on walking distance and accompanies symptoms in 6 minutes
Measured: Baseline, 3 months, 6 months
Secondary outcomes (6)
Pulmanory function indicators (FEV1/FVC, FEV1pred%)
Assessing changes of airway limitation
Measured: Baseline, 3 months, 6 months
Modified British medical research council questionnaire (mMRC)
Evaluating the severity of dyspnea, totally has 5 grade from 0-4, the higher grade represent a severer symptom
Measured: Baseline, 1 month, 2 months, 3 months, 6 months
COPD assessment test (CAT)
Assessing the quality of life, the total score ranges from 0-40, the higher score represent a worse outcome
Measured: Baseline, 1 month, 2 months, 3 months, 6 months
Times of acute exacerbation
Recording the frequency of acute exacerbation
Measured: Baseline, 1 month, 2 months, 3 months, 6 months
Self-rating anxiety scale (SAS)
Evaluating the stage of anxiety, the total score ranges from 20-80, the higher score represent a worse outcome
Measured: Baseline, 3 months, 6 months
Self-rating depression scale (SDS)
Evaluating the stage of depression, the total score ranges from 20-80, the higher score represent a worse outcome
Measured: Baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study startApr 2019 (estimated)
- Primary completionOct 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ShuGuang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital
- Responsible party
- Principal investigator, Sun Meng, ShuGuang Hospital
- Investigators
- Wei Zhang, Master, Study chair, Shanghai Shuguang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03892629
- Sponsor's protocol ID
- 2018YFC1313601003
- Status last verified
- Mar 2019
- First submitted
- 26 Mar 2019
- Last updated
- 1 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baduanjin Exercise for Patients With GOLD 2-3 Stable Chronic Obstructive Pulmonary Disease on Pulmonary Rehabilitation: A Prospective, Randomized, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03892629
- Acronym / sponsor ID
- 2018YFC1313601003
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- ShuGuang HospitalUniversity, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital
- Study start
- Apr 2019 (estimated)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 27 Mar 2019 (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.
Chronic Obstructive Pulmonary Disease (COPD) is a disease with a very high morbidity and mortality rate. When the lung function drops lower and lower, patients will bear great affliction physically and mentally. How to improve the quality of life in patients with COPD is a hot topic in the study of COPD now. Baduanjin, as one of the traditional Chinese qigong exercises, has the features of generous stretch, soft consistency, dynamic but static, which is an appropriate movement pattern for COPD patients.
Detailed description
To investigate the efficacy of Baduanjin exercise for patients with stable chronic obstructive pulmonary disease on phase II~III. A prospective, randomized, controlled clinical trial was designed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Baduanjin exercise group | Experimental | Behavioral: Baduanjin exerciseParticipants in this group received Baduanjin exercise |
| Instrument rehabilitation group | Active comparator | Device: Instrument rehabilitationParticipants in this group received rehabilitation by using tri-ball respiratory trainer |
| Baduanjin Exercise and Instrument Rehabilitation | Active comparator | Behavioral: Baduanjin exercise, Device: Instrument rehabilitationParticipants in this group received both instrument rehabilitation and Baduanjin exercise |
| No Intervention | No intervention | –Participants in this group only received routine drug-treatment |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged from 40 to 80 years
- Diagnosed with stable chronic obstructive pulmonary disease
- Phase II~III
Key exclusion criteria (4 listed)
- The condition was serious or movement restrained by other diseases
- In the acute exacerbation of chronic obstructive pulmonary disease
- Participants who have contraindications to exercise training
- Patients who have other serious acute, chronic organic disease or mental disorders
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 |
|---|---|---|
| Baduanjin exerciseParticipants received Baduanjin exercise. Each Baduanjin exercise session lasts 30 minutes and continues twice a day, 5 times per week for 12 weeks | Behavioural | Baduanjin Exercise and Instrument Rehabilitation, Baduanjin exercise group |
| Instrument rehabilitationParticipants received pulmanory rehabilitation by using tri-ball respiratory trainer. Each instrument exercise session lasts 30 minutes and continues twice a day, 5 times per week for 12 weeks | Device | Baduanjin Exercise and Instrument Rehabilitation, Instrument rehabilitation group |
Primary outcome
St. George's respiratory questionnaire (SGRQ)
Time frame: Baseline, 3 months, 6 months
Evaluating the changes of impact on quality of life
Six-minute walk test (6MWT)
Time frame: Baseline, 3 months, 6 months
Testing patients changes on walking distance and accompanies symptoms in 6 minutes
6 secondary outcomes
Pulmanory function indicators (FEV1/FVC, FEV1pred%)
Time frame: Baseline, 3 months, 6 months
Modified British medical research council questionnaire (mMRC)
Time frame: Baseline, 1 month, 2 months, 3 months, 6 months
COPD assessment test (CAT)
Time frame: Baseline, 1 month, 2 months, 3 months, 6 months
Times of acute exacerbation
Time frame: Baseline, 1 month, 2 months, 3 months, 6 months
Self-rating anxiety scale (SAS)
Time frame: Baseline, 3 months, 6 months
Self-rating depression scale (SDS)
Time frame: Baseline, 3 months, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2019.
- Individual participant dataSharing planned: No
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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.
Wei Zhang, Master study chair
Shanghai Shuguang 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 Baduanjin exercise and Instrument rehabilitation in people with Chronic Obstructive Pulmonary Disease, run by ShuGuang 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 4 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 1 Apr 2019. 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. 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 Meng Sun, Master (86-21-20256375, gulik002@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
St. George's respiratory questionnaire (SGRQ) (time frame: Baseline, 3 months, 6 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 1 Apr 2019.