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

NCT ID: NCT00686660

Last Updated: 2008-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2010-09-30

Brief Summary

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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

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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.

Conditions

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COPD Inflammation

Keywords

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copd rehabilitation quality of life inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

C-W G: in training period, patients do cycling on cycle ergometry at hospital. in non-training period, patients walk at community.

Group Type EXPERIMENTAL

cycling, walking

Intervention Type BEHAVIORAL

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.

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.

Group Type OTHER

cycling, non-walking

Intervention Type BEHAVIORAL

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.

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

Group Type EXPERIMENTAL

walking, walking

Intervention Type BEHAVIORAL

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.

4

W-nonW G: in training period, patients do walking along 60 meter place, in non-training period,patients don't walk at community.

Group Type OTHER

walking, non-walking

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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no. no. no. no.

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tongren Hospital

OTHER

Sponsor Role collaborator

Xuanwu Hospital, Beijing

OTHER

Sponsor Role collaborator

Beijing Fuxing Hospital

UNKNOWN

Sponsor Role collaborator

Peking University First Hospital

OTHER

Sponsor Role collaborator

Beijing Miner General Hospital

UNKNOWN

Sponsor Role collaborator

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role collaborator

Beijing Shuyi Hospital

OTHER

Sponsor Role collaborator

Beijing Daxing Hospital

UNKNOWN

Sponsor Role collaborator

Beijing Huairou Hospital

OTHER

Sponsor Role collaborator

Beijing Chao Yang Hospital

OTHER

Sponsor Role lead

Responsible Party

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beijing chaoyang hospital

Principal Investigators

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chen wang, phD

Role: PRINCIPAL_INVESTIGATOR

Beijing Chao Yang Hospital

Locations

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Beijing Chaoyang Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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ting yang, phD

Role: CONTACT

Phone: 86-136-5138-0809

Email: [email protected]

Other Identifiers

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COPD rehabilitation CYH 2007

Identifier Type: -

Identifier Source: org_study_id