A Multi-Center Study of Rehabilitation to Stable Chronic Obstructive Pulmonary Disease (COPD) Patients

The recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2008 by Beijing Chao Yang Hospital.
Recruitment status was Recruiting

Sponsor:

Collaborators:

Beijing Tongren Hospital

Beijing Xuanwu Hospital

Beijing Fuxing Hospital

Peking University First Hospital

Beijing Miner General Hospital

Beijing Guanganmen Chinese Medicine Hospital

Beijing Shunyi Hospital

Beijing Daxing Hospital

Beijing Huairou Hospital

Information provided by:

Beijing Chao Yang Hospital

ClinicalTrials.gov Identifier:

NCT00686660

First received: May 27, 2008

Last updated: June 13, 2008

Last verified: May 2008

History of Changes

Purpose

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

Condition	Intervention
COPD Inflammation	Behavioral: cycling, walking Behavioral: cycling, non-walking Behavioral: walking, walking Behavioral: walking, non-walking

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Breathing Problems COPD (Chronic Obstructive Pulmonary Disease) Depression Exercise and Physical Fitness Rehabilitation

U.S. FDA Resources

Further study details as provided by Beijing Chao Yang Hospital:

Primary Outcome Measures:

quality of life, dyspnea score, exercise endurance, depression,markers of inflammation (CRP, TNF, IL-8) [ Time Frame: two years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	300
Study Start Date:	September 2007
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 C-W G: in training period, patients do cycling on cycle ergometry at hospital. in non-training period, patients walk at community.	Behavioral: cycling, walking 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. Other Name: no.
2 C-nonW G: in training period, patients do cycling at cycle ergometry at hospital, in non-training period, patients don't walk at community.	Behavioral: cycling, non-walking 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. Other Name: no.
Experimental: 3 W-W G: in training period, patients do walking along 60 meters place at hospital, in non-training period, patients do walking in community	Behavioral: walking, walking 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. Other Name: no.
4 W-nonW G: in training period, patients do walking along 60 meter place, in non-training period,patients don't walk at community.	Behavioral: walking, non-walking 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. Other Name: no.

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.

Eligibility

Ages Eligible for Study:	40 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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；

Exclusion Criteria:

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;
cardia insufficiency;
hypertension which don't control well(systolic pressure>160mmHg and/or diastolic pressure> 100mmHg);
chronic liver or renal insufficiency;
cognitive handicap.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00686660

Contacts

Contact: ting yang, phD

86-136-5138-0809

dryangting@yahoo.com.cn

Locations

China, Beijing
Beijing Chaoyang Hospital	Recruiting
Beijing, Beijing, China, 100020
Principal Investigator: chen wang, phD

Sponsors and Collaborators

Beijing Chao Yang Hospital

Beijing Tongren Hospital

Beijing Xuanwu Hospital

Beijing Fuxing Hospital

Peking University First Hospital

Beijing Miner General Hospital

Beijing Guanganmen Chinese Medicine Hospital

Beijing Shunyi Hospital

Beijing Daxing Hospital

Beijing Huairou Hospital

Investigators

Principal Investigator:

chen wang, phD

Beijing Chaoyang Hospital

More Information

No publications provided

Responsible Party:	chen wang, beijing chaoyang hospital
ClinicalTrials.gov Identifier:	NCT00686660 History of Changes
Other Study ID Numbers:	COPD rehabilitation CYH 2007
Study First Received:	May 27, 2008
Last Updated:	June 13, 2008
Health Authority:	China: Food and Drug Administration

Keywords provided by Beijing Chao Yang Hospital:

copd
rehabilitation
quality of life
inflammation

Additional relevant MeSH terms:

Inflammation
Lung Diseases
Pulmonary Disease, Chronic Obstructive

Lung Diseases, Obstructive
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 17, 2013

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