COPDNCT00686660
A Multi-Center Study of Rehabilitation to Stable Chronic Obstructive Pulmonary Disease (COPD) Patients
A study testing cycling, walking, cycling, non-walking and walking, walking in people with COPD and Inflammation, run by Beijing Chao Yang Hospital at 1 site in China.
Trial summary
This is a multi-center prospective follow-up study. to choose the stable COPD patients in community to compare different modes of exercise (cycling and walking) to compare the effect of different exercises on the quality of life,exercise endurance,dyspnea and depression Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- COPD, Inflammation
- What is being tested?
- cycling, walking, cycling, non-walking and walking, walking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Sep 2007to Sep 2010
- 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
- according to GOLD, patients who are diagnosed as COPD, lung function at II or III grades (II:50%≤FEV1<60%pre；III:30%≤FEV1<50%pre）；
- 40≤age≤75 years old；
- don't have acute exacerbation in the past one month；
- SpO2 > 88% at rest；
Who cannot join
- diabetes,blood glucose don't control well;
- vascular diseases(vasculitis,deep venous thrombosis,varicose veins, etc);
- joint diseases which may affect activities;
- cerebrovascular diseases which may affect activities;
- unstable angina during the past 1 month of acute myocardial infarction in the past 6 months;
- severe arrhythmia;
Show all 10Show fewer
- cardia insufficiency;
- hypertension which don't control well(systolic pressure>160mmHg and/or diastolic pressure> 100mmHg);
- chronic liver or renal insufficiency;
- cognitive handicap.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Chaoyang Hospital
Beijing, Beijing Municipality, 100020
chen wang, phD
About this study
This is a multi-center prospective follow-up study.
- to choose the stable COPD patients in community
- to compare different modes of exercise (cycling and walking)
- to compare the effect of different exercises on the quality of life,exercise endurance,dyspnea and depression
Read the detailed description
This is a multi-center prospective follow-up study.More than 20 hospitals participate the research. More than 300 stable COPD patients will be recruited.It is a two-year study. There are four groups, cycling and walking group(C-WG),cycling and non-walking group(C-nonWG),walking and walking group(W-WG),walking and non-walking group(W-nonWG).
- All patients from four groups will finish baseline investigation and blood sample, including informed consent,questionaires(SGRQ,CRDQ,MRCQ,Depression Scale,etc.),spirometry,6MWT,MIP,MEP,BMI,CRP,TNF,IL-8, etc.Patients in C-WG and C-nonWG will finish cardiopulmonary test.
- Patients receive 8 weeks training program, includes upper and lower extremities endurance exercises and respiratory muscle endurance exercises. Patients in both CGs cycling at cycle ergometry. Patients in W-WG and W-nonWG walking instead. All patients receive training program twice per year, for two years. Patients were supervised by physicians or nurses at hospital while they are training.
- In the non-training period, patients in W-WG and C-WG will continue to walk at community, supervised by nurses who call them every month. The other two groups(C-nonWG and W-nonWG) do not receive special requirement on exercise.
- Telephone call interview will give to patients every month to find whether they have acute exacerbation. Patients are asked to record their activities during daytime in the diary cards.
- All patients will finish investigation and blood sample after one year and two year,including questionaires,spirometry,6MWT,MIP,MEP,BMI,CRP,TNF,IL-8, etc.Patients in CG will finish cardiopulmonary test.
- Conditions
- COPD, Inflammation
- Being tested
- cycling, walking, cycling, non-walking, walking, walking, walking, non-walking
- Keywords
- copd, rehabilitation, quality of life, inflammation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cycling, walkingBehavioural
Also called no.
In training period, patients do cycling on cycle ergometry. two times per week, 8 weeks per training period, two training period per year, two years.
In non-training period, patients do walking at community. four days per week,18 weeks per non-training period, two non-training period per year, two years.
cycling, non-walkingBehavioural
Also called no.
In training period, patients do cycling. two times a week, 8 weeks per training period, two training period per year, two years.
In non-training period, patients don't receive walk training.
walking, walkingBehavioural
Also called no.
In training period, patients do walking at hospital, two times per week, 8 weeks per training period, two training period per year, two years.
In non-training period, patients do walking at community, four days per week, 18 weeks per non-training period, two non-training period per year, two years.
walking, non-walkingBehavioural
Also called no.
In training period, patients do walking at hospital, two times per week, 8 weeks per training period, two training period per year, two years.
In non-training period, patients don't walking at community.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | C-W G: in training period, patients do cycling on cycle ergometry at hospital. in non-training period, patients walk at community. Receives: Behavioral: cycling, walking |
| 2 | Other | C-nonW G: in training period, patients do cycling at cycle ergometry at hospital, in non-training period, patients don't walk at community. Receives: Behavioral: cycling, non-walking |
| 3 | Experimental | W-W G: in training period, patients do walking along 60 meters place at hospital, in non-training period, patients do walking in community Receives: Behavioral: walking, walking |
| 4 | Other | W-nonW G: in training period, patients do walking along 60 meter place, in non-training period,patients don't walk at community. Receives: Behavioral: walking, non-walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of life, dyspnea score, exercise endurance, depression,markers of inflammation (CRP, TNF, IL-8)
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2008 (estimated)
- Study startSep 2007
- Primary completionJun 2010 (estimated)
- Study completionSep 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Beijing Chao Yang 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tongren Hospital, Xuanwu Hospital, Beijing, Fu Xing Hospital, Capital Medical University, Peking University First Hospital, Beijing Miner General Hospital, Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing Shuyi Hospital, Beijing Daxing Hospital, Beijing Huairou Hospital
- Investigators
- chen wang, phD, Principal investigator, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00686660
- Sponsor's protocol ID
- COPD rehabilitation CYH 2007
- Status last verified
- May 2008
- First submitted
- 27 May 2008
- Last updated
- 17 Jun 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Study of Rehabilitation to Stable Chronic Obstructive Pulmonary Disease (COPD) Patients
- ClinicalTrials.gov ID
- NCT00686660
- Acronym / sponsor ID
- COPD rehabilitation CYH 2007
- Conditions
- COPD, Inflammation
- Keywords
- copd, rehabilitation, quality of life, inflammation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Collaborators
- Beijing Tongren Hospital, Xuanwu Hospital, Beijing, Fu Xing Hospital, Capital Medical University, Peking University First Hospital, Beijing Miner General Hospital, Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing Shuyi Hospital, Beijing Daxing Hospital, Beijing Huairou Hospital
- Study start
- Sep 2007
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Sep 2010 (estimated)
- First posted
- 30 May 2008 (estimated)
- 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 is a multi-center prospective follow-up study.
- to choose the stable COPD patients in community
- to compare different modes of exercise (cycling and walking)
- to compare the effect of different exercises on the quality of life,exercise endurance,dyspnea and depression
Detailed description
This is a multi-center prospective follow-up study.More than 20 hospitals participate the research. More than 300 stable COPD patients will be recruited.It is a two-year study. There are four groups, cycling and walking group(C-WG),cycling and non-walking group(C-nonWG),walking and walking group(W-WG),walking and non-walking group(W-nonWG).
- All patients from four groups will finish baseline investigation and blood sample, including informed consent,questionaires(SGRQ,CRDQ,MRCQ,Depression Scale,etc.),spirometry,6MWT,MIP,MEP,BMI,CRP,TNF,IL-8, etc.Patients in C-WG and C-nonWG will finish cardiopulmonary test.
- Patients receive 8 weeks training program, includes upper and lower extremities endurance exercises and respiratory muscle endurance exercises. Patients in both CGs cycling at cycle ergometry. Patients in W-WG and W-nonWG walking instead. All patients receive training program twice per year, for two years. Patients were supervised by physicians or nurses at hospital while they are training.
- In the non-training period, patients in W-WG and C-WG will continue to walk at community, supervised by nurses who call them every month. The other two groups(C-nonWG and W-nonWG) do not receive special requirement on exercise.
- Telephone call interview will give to patients every month to find whether they have acute exacerbation. Patients are asked to record their activities during daytime in the diary cards.
- All patients will finish investigation and blood sample after one year and two year,including questionaires,spirometry,6MWT,MIP,MEP,BMI,CRP,TNF,IL-8, etc.Patients in CG will finish cardiopulmonary test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: cycling, walkingC-W G: in training period, patients do cycling on cycle ergometry at hospital. in non-training period, patients walk at community. |
| 2 | Other | Behavioral: cycling, non-walkingC-nonW G: in training period, patients do cycling at cycle ergometry at hospital, in non-training period, patients don't walk at community. |
| 3 | Experimental | Behavioral: walking, walkingW-W G: in training period, patients do walking along 60 meters place at hospital, in non-training period, patients do walking in community |
| 4 | Other | Behavioral: walking, non-walkingW-nonW G: in training period, patients do walking along 60 meter place, in non-training period,patients don't walk at community. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- according to GOLD, patients who are diagnosed as COPD, lung function at II or III grades (II:50%≤FEV1<60%pre；III:30%≤FEV1<50%pre）；
- 40≤age≤75 years old；
- don't have acute exacerbation in the past one month；
- SpO2 > 88% at rest；
Key exclusion criteria (10 listed)
- diabetes,blood glucose don't control well;
- vascular diseases(vasculitis,deep venous thrombosis,varicose veins, etc);
- joint diseases which may affect activities;
- cerebrovascular diseases which may affect activities;
- unstable angina during the past 1 month of acute myocardial infarction in the past 6 months;
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 |
|---|---|---|
| cycling, walkingAlso: no.In training period, patients do cycling on cycle ergometry. two times per week, 8 weeks per training period, two training period per year, two years. In non-training period, patients do walking at community. four days per week,18 weeks per non-training period, two non-training period per year, two years. | Behavioural | 1 |
| cycling, non-walkingAlso: no.In training period, patients do cycling. two times a week, 8 weeks per training period, two training period per year, two years. In non-training period, patients don't receive walk training. | Behavioural | 2 |
| walking, walkingAlso: no.In training period, patients do walking at hospital, two times per week, 8 weeks per training period, two training period per year, two years. In non-training period, patients do walking at community, four days per week, 18 weeks per non-training period, two non-training period per year, two years. | Behavioural | 3 |
| walking, non-walkingAlso: no.In training period, patients do walking at hospital, two times per week, 8 weeks per training period, two training period per year, two years. In non-training period, patients don't walking at community. | Behavioural | 4 |
Primary outcome
quality of life, dyspnea score, exercise endurance, depression,markers of inflammation (CRP, TNF, IL-8)
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2008.
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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.
chen wang, phD principal investigator
Beijing Chao Yang 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 cycling, walking, cycling, non-walking and walking, walking in people with COPD and Inflammation, run by Beijing Chao Yang 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 4 inclusion and 10 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 17 Jun 2008. 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 ting yang, phD (86-136-5138-0809, dryangting@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quality of life, dyspnea score, exercise endurance, depression,markers of inflammation (CRP, TNF, IL-8) (time frame: two years). 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 17 Jun 2008; AzTrials last refreshed its copy on 6 Nov 2026.