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

COPD Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00686660
• Other study ID #: COPD rehabilitation CYH 2007
• Status: Recruiting
• Phase: N/A
• First received: May 27, 2008
• Last updated: June 13, 2008
• Start date: September 2007
• Est. completion date: September 2010

Study information

• Verified date: May 2008
• Source: Beijing Chao Yang Hospital
• Contact: ting yang, phD
• Phone: 86-136-5138-0809
• Email: dryangting[@]yahoo.com.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical 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

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).

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: September 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• COPD
• Inflammation
• Pulmonary Disease, Chronic Obstructive

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
China	Beijing Chaoyang Hospital	Beijing	Beijing

Sponsors (10)

Lead Sponsor	Collaborator
Beijing Chao Yang Hospital	Beijing Daxing Hospital, Beijing Fuxing Hospital, Beijing Huairou Hospital, Beijing Miner General Hospital, Beijing Shuyi Hospital, Beijing Tongren Hospital, Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Peking University First Hospital, Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quality of life, dyspnea score, exercise endurance, depression,markers of inflammation (CRP, TNF, IL-8)		two years	Yes