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

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

Study Overview

• Status: Unknown
• Conditions: Inflammation; COPD
• Intervention / Treatment: Behavioral: cycling, walking; Behavioral: cycling, non-walking; Behavioral: walking, walking; Behavioral: walking, non-walking

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).

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.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ting yang, phD; Phone Number: 86-136-5138-0809; Email: dryangting@yahoo.com.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100020
      • Recruiting
      • Beijing ChaoYang Hospital
      • Principal Investigator: Chen Wang, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: no.
OTHER: 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 Names: 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 Names: no.
OTHER: 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 Names: no.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
quality of life, dyspnea score, exercise endurance, depression,markers of inflammation (CRP, TNF, IL-8)	two years

Collaborators and Investigators

• Sponsor: Beijing Chao Yang Hospital
• Collaborators: Peking University First Hospital; Guang'anmen Hospital of China Academy of Chinese Medical Sciences; Xuanwu Hospital, Beijing; Beijing Tongren Hospital; Beijing Fuxing Hospital; Beijing Huairou Hospital; Beijing Shuyi Hospital; Beijing Miner General Hospital; Beijing Daxing Hospital
• Investigators: Principal Investigator: chen wang, phD, Beijing Chao Yang Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (ANTICIPATED): June 1, 2010
• Study Completion (ANTICIPATED): September 1, 2010

Study Registration Dates

• First Submitted: May 27, 2008
• First Submitted That Met QC Criteria: May 29, 2008
• First Posted (ESTIMATE): May 30, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): June 17, 2008
• Last Update Submitted That Met QC Criteria: June 13, 2008
• Last Verified: May 1, 2008

More Information

Terms related to this study

• Keywords: rehabilitation; quality of life; inflammation; copd
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: COPD rehabilitation CYH 2007