Chronic Obstructive Pulmonary DiseaseNCT04348344
Study on the Prevention and Control System of Chronic Airway Diseases
A study testing pulmonary rehabilitation in people with Chronic Obstructive Pulmonary Disease, run by China-Japan Friendship Hospital.
Trial summary
In this study, patients with Chronic Obstructive Pulmonary Diseases (COPD) in stable and acute exacerbation stage were selected as the research objects, and the open, parallel and randomized controlled clinical trial design was adopted. Participants were randomly divided into trial group and control group. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- pulmonary rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 522 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2020to 1 Sep 2021
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- It meets the diagnostic criteria of global initiative for chronic obstructive pulmonary disease (gold 2017 Edition), is in a stable period of disease or meets the diagnostic criteria of guidelines for the prevention and treatment of bronchial asthma (GINA 2016 Edition)
- Have lived in the local area for more than 2 consecutive years, and there is no plan to go out for more than half a year in succession during the survey period
- No smoking history or no smoking for half a year or more
- 40-75 years old
Who cannot join
- Patients with history of chronic diseases, such as serious cardiovascular and cerebrovascular diseases, liver and kidney dysfunction, epilepsy and other nervous system diseases, mental diseases, psychiatric diseases, active pulmonary tuberculosis, tumor, anti tuberculosis treatment or combined influence information collection
- Patients who have undergone thoracic, abdominal and ophthalmic operations in the past 3 months
- Pregnant and lactating women
- Did not sign informed consent
Trial locations and contacts
No sites are listed yet.
About this study
In this study, patients with Chronic Obstructive Pulmonary Diseases (COPD) in stable and acute exacerbation stage were selected as the research objects, and the open, parallel and randomized controlled clinical trial design was adopted. Participants were randomly divided into trial group and control group. The control group was only given routine education, and the experimental group, on the basis of routine education, developed a respiratory rehabilitation training program lasting for 12 weeks according to the individual situation of patients. All participants were interviewed for 6 times (baseline and 4,8,12 weeks, 6 months and 12 months after admission) for a period of 1 year. Acute exacerbation, activity tolerance (6-minute walking test), living environment, clinical symptoms, lung function, airway inflammation water level index and biological samples were collected at each visit. At the same time, according to the diary filled in by the patients, the investigators can obtain the daily stay time indoors and outdoors and the longitude and latitude information of the regular stay fixed place, and geographic information system (GIS) is used to match the nearest environmental monitoring station, obtain the data of air pollutants and meteorological indicators (SO2, NO2, Co, O3, PM10, temperature and humidity, etc.), and estimate the individual exposure level of air pollutants.
Read the detailed description
First of all, the investigators need to obtain detailed history records, including cardio pulmonary vascular history, related complications, treatment history and other high-risk factors. After careful review, the investigators need to determine whether the patient is suitable to participate in the pulmonary rehabilitation plan. The investigators need to pay special attention to diseases that may affect the patient's performance, including special cardiovascular diseases, skeletal muscle and nervous system.
Functional evaluation: pulmonary function test, exercise cardiopulmonary function evaluation (6-minute walking test), grip strength test, psychological state evaluation ( Generalized Anxiety Disorder 7-item (GAD-7), Patient Health Questionnaire 9-item (phq-9)), nutrition screening and evaluation and others (general examination such as height, weight, BMI, waist and hip circumference, WHR, blood pressure, heart rate and blood biochemical examination; quality of life evaluation; other related individual evaluation Estimation includes smoking and sleep).
- Acute exacerbation: The exercise prescription of "hospitalization + home rehabilitation" was adopted, which mainly combined aerobic endurance training, intermittent strength training and inspiratory muscle training, as follows: Aerobic exercise: 4 times / week, 30min / time, fast walking or power cycling Strength training: unarmed or instrument, 4 times / week, 3 groups / time, 10-12 times / group Breath training: ① breath Trainer: once a day, 20-30min a time ② Abdominal breathing training: 1-2 times / day, 10min / time
- Stable patients:
Using the "home-based rehabilitation" exercise prescription, taking home exercise as the main form, using the sports bracelet and special respiratory rehabilitation app software, the home management system integrating home rehabilitation training, detection and feedback is mainly adopted, which is a combination of aerobic endurance training, intermittent strength training and inspiratory muscle training, as follows:
Aerobic exercise: 2-3 times / week, 30min / time, walk quickly Strength training: elastic band, 2-3 times / week, 3 groups / time, 10-12 times / group Breathing training: ① breathing exercise apparatus, 1-2 times / day, 10min / time
② Abdominal breathing training, 1-2 times / day, 10min / time
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- pulmonary rehabilitation
- Keywords
- Chronic Obstructive Pulmonary Disease, asthma, pulmonary rehabilitation, air pollutans
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulmonary rehabilitationBehavioural
Patients receive health education of pulmonary rehabilitation, using the "home-based rehabilitation" exercise prescription, taking home exercise as the main form, using the sports bracelet and special respiratory rehabilitation app software, the home management system integrating home rehabilitation training, detection and feedback is mainly adopted, which is a combination of aerobic endurance training: walking, intermittent strength training: elastic band and inspiratory muscle training:apparatus, abdominal breathing training.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | health education of pulmonary rehabilitation pulmonary rehabilitation including aerobic exercise，strength training and breath training.
Patients in stable stages using the "home-based rehabilitation" exercise prescription, taking home exercise, using the sports bracelet and special respiratory rehabilitation app software, the home management system integrating home rehabilitation training, detection and feedback is mainly adopted, which is a combination of aerobic endurance training, intermittent strength training and inspiratory muscle training. Receives: Behavioral: pulmonary rehabilitation |
| control group | No intervention | health education of pulmonary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline 6-minute Walking Distance at 4, 8, 12 weeks, 6 months and 12 months
walking distance in 6-minute walking test
Measured: baseline and 4, 8, 12 weeks, 6 months and 12 months
Times of acute exacerbation
times of acute exacerbation in the period of one year
Measured: through study completion, an average of 1 year
Secondary outcomes (13)
Time from the beginning of follow-up to the first acute exacerbation and the duration of the first acute exacerbation
Time from the beginning of follow-up to the first acute exacerbation and the duration of the first acute exacerbation
Measured: 9 months
Change from Baseline Fractional exhaled Nitric Oxide (FeNO) at 4, 8, 12 weeks, 6 months and 12 months
changes of Fractional exhaled Nitric Oxide (FeNO)
Measured: baseline and 4, 8, 12 weeks, 6 months and 12 months
Change from Baseline Eosinophil Count in Sputum at 4, 8, 12 weeks, 6 months and 12 months
Eosinophil Count
Measured: baseline and 4, 8, 12 weeks, 6 months and 12 months
Change from Baseline Inflammatory Factors in sputum at 4, 8, 12 weeks, 6 months and 12 months
inflammatory factors in sputum
Measured: baseline and 4, 8, 12 weeks, 6 months and 12 months
Change from Baseline modified Medical Research Council dyspnea (mMRC) at 4, 8, 12 weeks, 6 months and 12 months
the minimum values is 0 and maximum values is 4, the higher scores mean a worse outcome.
Measured: baseline and 4, 8, 12 weeks, 6 months and 12 months
Change from Baseline COPD assessment test (CAT) at 4, 8, 12 weeks, 6 months and 12 months
the minimum values is 0 and maximum values is 40, the higher scores mean a worse outcome.
Measured: baseline and 4, 8, 12 weeks, 6 months and 12 months
Change from Baseline St George's questionnaire (SGRQ) at 4, 8, 12 weeks, 6 months and 12 months
the minimum values is 0 and maximum values is 100, the higher scores mean a worse outcome.
Measured: baseline and 4, 8, 12 weeks, 6 months and 12 months
Change from Baseline Patient Health Questionnaire 9-item (PHQ-9) at 4, 8, 12 weeks, 6 months and 12 months
the minimum values is 0 and maximum values is 27, the higher scores mean a worse outcome.
Measured: baseline and 4, 8, 12 weeks, 6 months and 12 months
Change from Baseline Generalized Anxiety Disorder 7-item (GAD-7) at 4, 8, 12 weeks, 6 months and 12 months
the minimum values is 0 and maximum values is 21, the higher scores mean a worse outcome.
Measured: baseline and 4, 8, 12 weeks, 6 months and 12 months
Change from Baseline Pittsburgh Sleep Quality Index (PSQI) at 4, 8, 12 weeks, 6 months and 12 months
the minimum values is 0 and maximum values is 21, the higher scores mean a worse outcome.
Measured: baseline and 4, 8, 12 weeks, 6 months and 12 months
Change from Baseline Pulmonary Function of FEV1 at 4, 8, 12 weeks, 6 months and 12 months
FEV1
Measured: baseline and 4, 8, 12 weeks, 6 months and 12 months
Change from Baseline Pulmonary Function of FVC at 4, 8, 12 weeks, 6 months and 12 months
FVC
Measured: baseline and 4, 8, 12 weeks, 6 months and 12 months
Change from Baseline Pulmonary Function of FEV1/FVC at 4, 8, 12 weeks, 6 months and 12 months
FEV1/FVC
Measured: baseline and 4, 8, 12 weeks, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start1 Jun 2020 (estimated)
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 522 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongtao Niu, China-Japan Friendship Hospital
- Investigators
- Ting Yang, MD, Study chair, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04348344
- Sponsor's protocol ID
- 2019-161-K110
- Status last verified
- May 2020
- First submitted
- 7 Apr 2020
- Last updated
- 13 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang C, Xu J, Yang L, Xu Y, Zhang X, Bai C, Kang J, Ran P, Shen H, Wen F, Huang K, Yao W, Sun T, Shan G, Yang T, Lin Y, Wu S, Zhu J, Wang R, Shi Z, Zhao J, Ye X, Song Y, Wang Q, Zhou Y, Ding L, Yang T, Chen Y, Guo Y, Xiao F, Lu Y, Peng X, Zhang B, Xiao D, Chen CS, Wang Z, Zhang H, Bu X, Zhang X, An L, Zhang S, Cao Z, Zhan Q, Yang Y, Cao B, Dai H, Liang L, He J; China Pulmonary Health Study Group. Prevalence and risk factors of chronic obstructive pulmonary disease in China (the China Pulmonary Health [CPH] study): a national cross-sectional study. Lancet. 2018 Apr 28;391(10131):1706-1717. doi: 10.1016/S0140-6736(18)30841-9. Epub 2018 Apr 9.
PubMed 29650248Alison JA, McKeough ZJ, Johnston K, McNamara RJ, Spencer LM, Jenkins SC, Hill CJ, McDonald VM, Frith P, Cafarella P, Brooke M, Cameron-Tucker HL, Candy S, Cecins N, Chan AS, Dale MT, Dowman LM, Granger C, Halloran S, Jung P, Lee AL, Leung R, Matulick T, Osadnik C, Roberts M, Walsh J, Wootton S, Holland AE; Lung Foundation Australia and the Thoracic Society of Australia and New Zealand. Australian and New Zealand Pulmonary Rehabilitation Guidelines. Respirology. 2017 May;22(4):800-819. doi: 10.1111/resp.13025. Epub 2017 Mar 24.
PubMed 28339144Spruit MA, Singh SJ, Garvey C, ZuWallack R, Nici L, Rochester C, Hill K, Holland AE, Lareau SC, Man WD, Pitta F, Sewell L, Raskin J, Bourbeau J, Crouch R, Franssen FM, Casaburi R, Vercoulen JH, Vogiatzis I, Gosselink R, Clini EM, Effing TW, Maltais F, van der Palen J, Troosters T, Janssen DJ, Collins E, Garcia-Aymerich J, Brooks D, Fahy BF, Puhan MA, Hoogendoorn M, Garrod R, Schols AM, Carlin B, Benzo R, Meek P, Morgan M, Rutten-van Molken MP, Ries AL, Make B, Goldstein RS, Dowson CA, Brozek JL, Donner CF, Wouters EF; ATS/ERS Task Force on Pulmonary Rehabilitation. An official American Thoracic Society/European Respiratory Society statement: key concepts and advances in pulmonary rehabilitation. Am J Respir Crit Care Med. 2013 Oct 15;188(8):e13-64. doi: 10.1164/rccm.201309-1634ST.
PubMed 24127811Loeckx M, Rabinovich RA, Demeyer H, Louvaris Z, Tanner R, Rubio N, Frei A, De Jong C, Gimeno-Santos E, Rodrigues FM, Buttery SC, Hopkinson NS, Busching G, Strassmann A, Serra I, Vogiatzis I, Garcia-Aymerich J, Polkey MI, Troosters T. Smartphone-Based Physical Activity Telecoaching in Chronic Obstructive Pulmonary Disease: Mixed-Methods Study on Patient Experiences and Lessons for Implementation. JMIR Mhealth Uhealth. 2018 Dec 21;6(12):e200. doi: 10.2196/mhealth.9774.
PubMed 30578215Storer TW. Exercise in chronic pulmonary disease: resistance exercise prescription. Med Sci Sports Exerc. 2001 Jul;33(7 Suppl):S680-92. doi: 10.1097/00005768-200107001-00006.
PubMed 11462077
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Prevention and Control System of Chronic Airway Diseases
- ClinicalTrials.gov ID
- NCT04348344
- Acronym / sponsor ID
- 2019-161-K110
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic Obstructive Pulmonary Disease, asthma, pulmonary rehabilitation, air pollutans
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 522 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 16 Apr 2020 (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.
In this study, patients with Chronic Obstructive Pulmonary Diseases (COPD) in stable and acute exacerbation stage were selected as the research objects, and the open, parallel and randomized controlled clinical trial design was adopted. Participants were randomly divided into trial group and control group. The control group was only given routine education, and the experimental group, on the basis of routine education, developed a respiratory rehabilitation training program lasting for 12 weeks according to the individual situation of patients. All participants were interviewed for 6 times (baseline and 4,8,12 weeks, 6 months and 12 months after admission) for a period of 1 year. Acute exacerbation, activity tolerance (6-minute walking test), living environment, clinical symptoms, lung function, airway inflammation water level index and biological samples were collected at each visit. At the same time, according to the diary filled in by the patients, the investigators can obtain the daily stay time indoors and outdoors and the longitude and latitude information of the regular stay fixed place, and geographic information system (GIS) is used to match the nearest environmental monitoring station, obtain the data of air pollutants and meteorological indicators (SO2, NO2, Co, O3, PM10, temperature and humidity, etc.), and estimate the individual exposure level of air pollutants.
Detailed description
First of all, the investigators need to obtain detailed history records, including cardio pulmonary vascular history, related complications, treatment history and other high-risk factors. After careful review, the investigators need to determine whether the patient is suitable to participate in the pulmonary rehabilitation plan. The investigators need to pay special attention to diseases that may affect the patient's performance, including special cardiovascular diseases, skeletal muscle and nervous system.
Functional evaluation: pulmonary function test, exercise cardiopulmonary function evaluation (6-minute walking test), grip strength test, psychological state evaluation ( Generalized Anxiety Disorder 7-item (GAD-7), Patient Health Questionnaire 9-item (phq-9)), nutrition screening and evaluation and others (general examination such as height, weight, BMI, waist and hip circumference, WHR, blood pressure, heart rate and blood biochemical examination; quality of life evaluation; other related individual evaluation Estimation includes smoking and sleep).
- Acute exacerbation: The exercise prescription of "hospitalization + home rehabilitation" was adopted, which mainly combined aerobic endurance training, intermittent strength training and inspiratory muscle training, as follows: Aerobic exercise: 4 times / week, 30min / time, fast walking or power cycling Strength training: unarmed or instrument, 4 times / week, 3 groups / time, 10-12 times / group Breath training: ① breath Trainer: once a day, 20-30min a time ② Abdominal breathing training: 1-2 times / day, 10min / time
- Stable patients:
Using the "home-based rehabilitation" exercise prescription, taking home exercise as the main form, using the sports bracelet and special respiratory rehabilitation app software, the home management system integrating home rehabilitation training, detection and feedback is mainly adopted, which is a combination of aerobic endurance training, intermittent strength training and inspiratory muscle training, as follows:
Aerobic exercise: 2-3 times / week, 30min / time, walk quickly Strength training: elastic band, 2-3 times / week, 3 groups / time, 10-12 times / group Breathing training: ① breathing exercise apparatus, 1-2 times / day, 10min / time
② Abdominal breathing training, 1-2 times / day, 10min / time
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: pulmonary rehabilitationhealth education of pulmonary rehabilitation pulmonary rehabilitation including aerobic exercise，strength training and breath training. Patients in stable stages using the "home-based rehabilitation" exercise prescription, taking home exercise, using the sports bracelet and special respiratory rehabilitation app software, the home management system integrating home rehabilitation training, detection and feedback is mainly adopted, which is a combination of aerobic endurance training, intermittent strength training and inspiratory muscle training. |
| control group | No intervention | –health education of pulmonary rehabilitation |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- It meets the diagnostic criteria of global initiative for chronic obstructive pulmonary disease (gold 2017 Edition), is in a stable period of disease or meets the diagnostic criteria of guidelines for the prevention and treatment of bronchial asthma (GINA 2016 Edition)
- Have lived in the local area for more than 2 consecutive years, and there is no plan to go out for more than half a year in succession during the survey period
- No smoking history or no smoking for half a year or more
- 40-75 years old
Key exclusion criteria (4 listed)
- Patients with history of chronic diseases, such as serious cardiovascular and cerebrovascular diseases, liver and kidney dysfunction, epilepsy and other nervous system diseases, mental diseases, psychiatric diseases, active pulmonary tuberculosis, tumor, anti tuberculosis treatment or combined influence information collection
- Patients who have undergone thoracic, abdominal and ophthalmic operations in the past 3 months
- Pregnant and lactating women
- Did not sign informed consent
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 |
|---|---|---|
| pulmonary rehabilitationPatients receive health education of pulmonary rehabilitation, using the "home-based rehabilitation" exercise prescription, taking home exercise as the main form, using the sports bracelet and special respiratory rehabilitation app software, the home management system integrating home rehabilitation training, detection and feedback is mainly adopted, which is a combination of aerobic endurance training: walking, intermittent strength training: elastic band and inspiratory muscle training:apparatus, abdominal breathing training. | Behavioural | intervention group |
Primary outcome
Change from Baseline 6-minute Walking Distance at 4, 8, 12 weeks, 6 months and 12 months
Time frame: baseline and 4, 8, 12 weeks, 6 months and 12 months
walking distance in 6-minute walking test
Times of acute exacerbation
Time frame: through study completion, an average of 1 year
times of acute exacerbation in the period of one year
13 secondary outcomes
Time from the beginning of follow-up to the first acute exacerbation and the duration of the first acute exacerbation
Time frame: 9 months
Change from Baseline Fractional exhaled Nitric Oxide (FeNO) at 4, 8, 12 weeks, 6 months and 12 months
Time frame: baseline and 4, 8, 12 weeks, 6 months and 12 months
Change from Baseline Eosinophil Count in Sputum at 4, 8, 12 weeks, 6 months and 12 months
Time frame: baseline and 4, 8, 12 weeks, 6 months and 12 months
Change from Baseline Inflammatory Factors in sputum at 4, 8, 12 weeks, 6 months and 12 months
Time frame: baseline and 4, 8, 12 weeks, 6 months and 12 months
Change from Baseline modified Medical Research Council dyspnea (mMRC) at 4, 8, 12 weeks, 6 months and 12 months
Time frame: baseline and 4, 8, 12 weeks, 6 months and 12 months
Change from Baseline COPD assessment test (CAT) at 4, 8, 12 weeks, 6 months and 12 months
Time frame: baseline and 4, 8, 12 weeks, 6 months and 12 months
Change from Baseline St George's questionnaire (SGRQ) at 4, 8, 12 weeks, 6 months and 12 months
Time frame: baseline and 4, 8, 12 weeks, 6 months and 12 months
Change from Baseline Patient Health Questionnaire 9-item (PHQ-9) at 4, 8, 12 weeks, 6 months and 12 months
Time frame: baseline and 4, 8, 12 weeks, 6 months and 12 months
Change from Baseline Generalized Anxiety Disorder 7-item (GAD-7) at 4, 8, 12 weeks, 6 months and 12 months
Time frame: baseline and 4, 8, 12 weeks, 6 months and 12 months
Change from Baseline Pittsburgh Sleep Quality Index (PSQI) at 4, 8, 12 weeks, 6 months and 12 months
Time frame: baseline and 4, 8, 12 weeks, 6 months and 12 months
Change from Baseline Pulmonary Function of FEV1 at 4, 8, 12 weeks, 6 months and 12 months
Time frame: baseline and 4, 8, 12 weeks, 6 months and 12 months
Change from Baseline Pulmonary Function of FVC at 4, 8, 12 weeks, 6 months and 12 months
Time frame: baseline and 4, 8, 12 weeks, 6 months and 12 months
Change from Baseline Pulmonary Function of FEV1/FVC at 4, 8, 12 weeks, 6 months and 12 months
Time frame: baseline and 4, 8, 12 weeks, 6 months and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2020.
- Results publication: PubMed 29650248Wang C, Xu J, Yang L, Xu Y, Zhang X, Bai C, Kang J, Ran P, Shen H, Wen F, Huang K, Yao W, Sun T, Shan G, Yang T, Lin Y, Wu S, Zhu J, Wang R, Shi Z, Zhao J, Ye X, Song Y, Wang Q, Zhou Y, Ding L, Yang T, Chen Y, Guo Y, Xiao F, Lu Y, Peng X, Zhang B, Xiao D, Chen CS, Wang Z, Zhang H, Bu X, Zhang X, An L, Zhang S, Cao Z, Zhan Q, Yang Y, Cao B, Dai H, Liang L, He J; China Pulmonary Health Study Group. Prevalence and risk factors of chronic obstructive pulmonary disease in China (the China Pulmonary Health [CPH] study): a national cross-sectional study. Lancet. 2018 Apr 28;391(10131):1706-1717. doi: 10.1016/S0140-6736(18)30841-9. Epub 2018 Apr 9.
- Results publication: PubMed 28339144Alison JA, McKeough ZJ, Johnston K, McNamara RJ, Spencer LM, Jenkins SC, Hill CJ, McDonald VM, Frith P, Cafarella P, Brooke M, Cameron-Tucker HL, Candy S, Cecins N, Chan AS, Dale MT, Dowman LM, Granger C, Halloran S, Jung P, Lee AL, Leung R, Matulick T, Osadnik C, Roberts M, Walsh J, Wootton S, Holland AE; Lung Foundation Australia and the Thoracic Society of Australia and New Zealand. Australian and New Zealand Pulmonary Rehabilitation Guidelines. Respirology. 2017 May;22(4):800-819. doi: 10.1111/resp.13025. Epub 2017 Mar 24.
- Results publication: PubMed 24127811Spruit MA, Singh SJ, Garvey C, ZuWallack R, Nici L, Rochester C, Hill K, Holland AE, Lareau SC, Man WD, Pitta F, Sewell L, Raskin J, Bourbeau J, Crouch R, Franssen FM, Casaburi R, Vercoulen JH, Vogiatzis I, Gosselink R, Clini EM, Effing TW, Maltais F, van der Palen J, Troosters T, Janssen DJ, Collins E, Garcia-Aymerich J, Brooks D, Fahy BF, Puhan MA, Hoogendoorn M, Garrod R, Schols AM, Carlin B, Benzo R, Meek P, Morgan M, Rutten-van Molken MP, Ries AL, Make B, Goldstein RS, Dowson CA, Brozek JL, Donner CF, Wouters EF; ATS/ERS Task Force on Pulmonary Rehabilitation. An official American Thoracic Society/European Respiratory Society statement: key concepts and advances in pulmonary rehabilitation. Am J Respir Crit Care Med. 2013 Oct 15;188(8):e13-64. doi: 10.1164/rccm.201309-1634ST.
- Results publication: PubMed 30578215Loeckx M, Rabinovich RA, Demeyer H, Louvaris Z, Tanner R, Rubio N, Frei A, De Jong C, Gimeno-Santos E, Rodrigues FM, Buttery SC, Hopkinson NS, Busching G, Strassmann A, Serra I, Vogiatzis I, Garcia-Aymerich J, Polkey MI, Troosters T. Smartphone-Based Physical Activity Telecoaching in Chronic Obstructive Pulmonary Disease: Mixed-Methods Study on Patient Experiences and Lessons for Implementation. JMIR Mhealth Uhealth. 2018 Dec 21;6(12):e200. doi: 10.2196/mhealth.9774.
- Results publication: PubMed 11462077Storer TW. Exercise in chronic pulmonary disease: resistance exercise prescription. Med Sci Sports Exerc. 2001 Jul;33(7 Suppl):S680-92. doi: 10.1097/00005768-200107001-00006.
- 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.
Ting Yang, MD study chair
China-Japan Friendship Hospital
Questions about this trial
What is this clinical trial studying?
A study testing pulmonary rehabilitation in people with Chronic Obstructive Pulmonary Disease, run by China-Japan Friendship Hospital.
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 4 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 13 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Ting Yang, MD (13651380809, dryangting@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline 6-minute Walking Distance at 4, 8, 12 weeks, 6 months and 12 months (time frame: baseline and 4, 8, 12 weeks, 6 months and 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?
On the ClinicalTrials.gov record for NCT04348344, which also lists 5 linked publications.
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 13 May 2020.