A Multi-Center Study of Rehabilitation to Stable Chronic Obstructive Pulmonary Disease (COPD) Patients
Primary Purpose
COPD, Inflammation
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
cycling, walking
cycling, non-walking
walking, walking
walking, non-walking
Sponsored by

About this trial
This is an interventional treatment trial for COPD focused on measuring copd, rehabilitation, quality of life, inflammation
Eligibility 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.
Sites / Locations
- Beijing Chaoyang HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Other
Experimental
Other
Arm Label
1
2
3
4
Arm Description
C-W G: in training period, patients do cycling on cycle ergometry at hospital. in non-training period, patients walk at community.
C-nonW G: in training period, patients do cycling at cycle ergometry at hospital, in non-training period, patients don't walk at community.
W-W G: in training period, patients do walking along 60 meters place at hospital, in non-training period, patients do walking in community
W-nonW G: in training period, patients do walking along 60 meter place, in non-training period,patients don't walk at community.
Outcomes
Primary Outcome Measures
quality of life, dyspnea score, exercise endurance, depression,markers of inflammation (CRP, TNF, IL-8)
Secondary Outcome Measures
Full Information
NCT ID
NCT00686660
First Posted
May 27, 2008
Last Updated
June 13, 2008
Sponsor
Beijing Chao Yang Hospital
Collaborators
Beijing Tongren Hospital, Xuanwu Hospital, Beijing, Beijing Fuxing Hospital, 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
1. Study Identification
Unique Protocol Identification Number
NCT00686660
Brief Title
A Multi-Center Study of Rehabilitation to Stable Chronic Obstructive Pulmonary Disease (COPD) Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Unknown status
Study Start Date
September 2007 (undefined)
Primary Completion Date
June 2010 (Anticipated)
Study Completion Date
September 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Beijing Chao Yang Hospital
Collaborators
Beijing Tongren Hospital, Xuanwu Hospital, Beijing, Beijing Fuxing Hospital, 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
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Inflammation
Keywords
copd, rehabilitation, quality of life, inflammation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
C-W G: in training period, patients do cycling on cycle ergometry at hospital. in non-training period, patients walk at community.
Arm Title
2
Arm Type
Other
Arm Description
C-nonW G: in training period, patients do cycling at cycle ergometry at hospital, in non-training period, patients don't walk at community.
Arm Title
3
Arm Type
Experimental
Arm Description
W-W G: in training period, patients do walking along 60 meters place at hospital, in non-training period, patients do walking in community
Arm Title
4
Arm Type
Other
Arm Description
W-nonW G: in training period, patients do walking along 60 meter place, in non-training period,patients don't walk at community.
Intervention Type
Behavioral
Intervention Name(s)
cycling, walking
Other Intervention Name(s)
no.
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
cycling, non-walking
Other Intervention Name(s)
no.
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
walking, walking
Other Intervention Name(s)
no.
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
walking, non-walking
Other Intervention Name(s)
no.
Intervention Description
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.
Primary Outcome Measure Information:
Title
quality of life, dyspnea score, exercise endurance, depression,markers of inflammation (CRP, TNF, IL-8)
Time Frame
two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ting yang, phD
Phone
86-136-5138-0809
Email
dryangting@yahoo.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
chen wang, phD
Organizational Affiliation
Beijing Chao Yang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Chaoyang Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
chen wang, phD
12. IPD Sharing Statement
Learn more about this trial
A Multi-Center Study of Rehabilitation to Stable Chronic Obstructive Pulmonary Disease (COPD) Patients
We'll reach out to this number within 24 hrs