NCT00686660

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 30, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

June 17, 2008

Status Verified

May 1, 2008

Enrollment Period

2.8 years

First QC Date

May 27, 2008

Last Update Submit

June 13, 2008

Conditions

Keywords

copdrehabilitationquality of lifeinflammation

Outcome Measures

Primary Outcomes (1)

  • quality of life, dyspnea score, exercise endurance, depression,markers of inflammation (CRP, TNF, IL-8)

    two years

Study Arms (4)

1

EXPERIMENTAL

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

2

OTHER

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

3

EXPERIMENTAL

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

4

OTHER

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

Interventions

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.

Also known as: no.
1

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.

Also known as: no.
2

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.

Also known as: no.
3

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.

Also known as: no.
4

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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);
  • ≤age≤75 years old;
  • don't have acute exacerbation in the past one month;
  • SpO2 \> 88% at rest;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Chaoyang Hospital

Beijing, Beijing Municipality, 100020, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveInflammation

Interventions

Walking

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Officials

  • chen wang, phD

    Beijing Chao Yang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 27, 2008

First Posted

May 30, 2008

Study Start

September 1, 2007

Primary Completion

June 1, 2010

Study Completion

September 1, 2010

Last Updated

June 17, 2008

Record last verified: 2008-05

Locations