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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00686660
Enrollment
300
Registered
2008-05-30
Start date
2007-09-30
Completion date
2010-09-30
Last updated
2008-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD, Inflammation

Keywords

copd, rehabilitation, quality of life, inflammation

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). 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.

Interventions

BEHAVIORALcycling, 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.

BEHAVIORALcycling, 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.

BEHAVIORALwalking, 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.

BEHAVIORALwalking, 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.

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
quality of life, dyspnea score, exercise endurance, depression,markers of inflammation (CRP, TNF, IL-8)two years

Countries

China

Contacts

Primary Contactting yang, phD
dryangting@yahoo.com.cn86-136-5138-0809

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026