NCT00413543

Brief Summary

This is a study to evaluate the effects of early pulmonary rehabilitation within 10 days after discharge from the hospital after a COPD exacerbation on exercise tolerance, exacerbations, re-admissions and the quality of life during 6 months.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Oct 2006

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 19, 2006

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

September 18, 2015

Status Verified

September 1, 2015

Enrollment Period

1 year

First QC Date

December 18, 2006

Last Update Submit

September 17, 2015

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPDexacerbationpulmonary rehabilitationexercise toleranceexacerbationsquality of lifereadmissions

Outcome Measures

Primary Outcomes (1)

  • Exercise tolerance in meters

    2 years

Secondary Outcomes (1)

  • Exacerbations, readmissions and quality of life during follow-up

    2 years

Study Arms (2)

interventional, rehabilitation

EXPERIMENTAL

'early pulmonary lung rehabilitation'

Other: early pulmonary lung rehabilitation

control

NO INTERVENTION

"standard care"

Interventions

early pulmonary lung rehabilitationOTHER

early pulmonary rehabilitation, 10 days after discharge

interventional, rehabilitation

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients ≥ 40 years and \< 80 years admitted to the hospital via ER
  • COPD at least Gold II
  • At least 10 pack years of smoking history
  • Physical therapy is tolerated, outside pulmonary rehabilitation

You may not qualify if:

  • Rehabilitation program \< 1 year
  • Intolerance to prednisone
  • Non-compliance
  • Comorbidity limiting pulmonary rehabilitation
  • History of asthma
  • Prior randomisation
  • Findings on X thorax other than fitting with COPD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Isala Klinieken

Zwolle, Overijssel, 8011 JW, Netherlands

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

  • Jan Willem Van den Berg, Dr.

    Isala

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
pulmonologist

Study Record Dates

First Submitted

December 18, 2006

First Posted

December 19, 2006

Study Start

October 1, 2006

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

September 18, 2015

Record last verified: 2015-09

Locations

NL(1)