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COPD-EXA-REHAB. Early Pulmonary Rehabilitation of Patients With Acute Exacerbation of COPD

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ClinicalTrials.gov Identifier: NCT02987439
Recruitment Status : Unknown
Verified December 2016 by Jon Torgny Wilcke, University Hospital, Gentofte, Copenhagen.
Recruitment status was:  Recruiting
First Posted : December 9, 2016
Last Update Posted : December 9, 2016
Sponsor:
Information provided by (Responsible Party):
Jon Torgny Wilcke, University Hospital, Gentofte, Copenhagen

Brief Summary:
Purpose: In a randomized controlled trial we will assess the effect of early pulmonary rehabilitation in patient with an acute exacerbation of chronic obstructive lung disease (AECOPD).

Condition or disease Intervention/treatment Phase
Chronic Obstructive Lung Disease Other: Pulmonary rehabilitation Not Applicable

Detailed Description:

Background:

Pulmonary rehabilitation is a key element in treatment of stable COPD. A Cochrane review from 2011 showed that early pulmonary rehabilitation for COPD exacerbation 6-10 days after discharge, or during prolonged hospitalization significantly reduced mortality and hospitalizations without serious side effects. It consist of 9 small studies and larger RCT studies is required to establish the effect of early pulmonary rehabilitation.

AIM: The aim of the study is to investigate whether early pulmonary rehabilitation can reduce mortality og hospitalization in patients with acute exacerbation of COPD. Secondary increase exercise capacity, reduce symptoms and improve quality of life.

Methods:

Design: The study is a single center randomized, controlled, open label trial, with an intervention group and a control group. The patients are randomized to either a prespecified rehabilitation program, which is standardized to patients with COPD, or usual care. The patients' data are being recorded at baseline and visits at 2 and 6 months: Lung function (FEV1, FVC), CO in exhaled air, O2 saturation in the blood (and possibly O2 supplement), Heart Rate, Dyspnoea (Borg scale and Medical Research Council (MRC scale)), Quality of life (CAT), Walk Test (ISWT and ESWT), Daily medication, Outdoor activity. Information on mortality, hospital admissions, emergency room visits after 6 and 12 months is obtained from relevant databases.

Population: Patients Hospitalized with an exacerbation of COPD to the department of respiratory medicine at Gentofte Hospital. The inclusion criteria are: A diagnose of COPD, Age >18, expected discharge to own homes, can walk 10 meters independently (with or without a walking aid). Exclusion criteria are: Life expectancy <6 months due to another illness (cancer, severe heart disease, etc.), difficulties in understanding and speaking Danish (e.g. due to dementia), place of residence outside Gentofte Hospital admission area.

Randomization: A total of 150 COPD patients will be included. The participants are randomized to early rehabilitation or usual care in a 1:1 ratio, using a computer-generated block-randomization for each center. The participant is presented with a sealed envelope containing a piece of paper with either "A" (= REHAB) or "B" (= usual care). The randomization list is stored at Gentofte Hospital in a sealed envelope.

A participant who is readmitted will not be re-randomized.

Patients arre introduced to an acute telephone hotline, operated by a nurse.

The patients in the intervention group will during Hospitalization begin the rehabilitation program. The program consist of exercise training, breathing techniques and education. Before discharge the patients will be assessed to either A: outpatient rehabilitation in hospital or community clinic or B: Rehabilitation in their own homes twice weekly in 7 weeks


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: COPD-EXA-REHAB. Early Pulmonary Rehabilitation of Patients With Acute Exacerbation of COPD
Study Start Date : November 2013
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Standard care group
  • Standard medical treatment for the exacerbation of COPD
  • Standard medical treatment of COPD according to GOLD
  • A visit by a pulmonary nurse at the patients own home 3-5 days after discharge. Lung function and smoking history is recorded. Correct use of inhaler is instructed.
  • Visit in the outpatient clinic within the next 2-6 months after discharge as follow-up
  • In the outpatient clinic they will receive an offer of pulmonary rehabilitation
Experimental: Rehabilitation group

The group will begin pulmonary rehabilitation during hospital admission. Afterwards a rehabilitation program twice weekly for 7 weeks.

Beside rehabilitation they will receive same treatment as the standard care group

Other: Pulmonary rehabilitation
The intervention is pulmonary rehabilitation




Primary Outcome Measures :
  1. Composite outcome of 1 year mortality or hospital readmission [ Time Frame: 12 months ]
    It is all cause mortality in 12 months follow-up period.. Readmission is the proportion of patients with at least 1 hospital readmission in 12 months follow-up period. Intention-to-treat analysis.Secondarily per-protocol analysis.


Secondary Outcome Measures :
  1. All cause mortality and time to death [ Time Frame: 12 months ]
  2. All cause hospital readmission and time to readmission [ Time Frame: 12 months ]
    Proportion of patients with at least 1 hospital readmission of any cause

  3. Hospital readmission by respiratory cause [ Time Frame: 12 months ]
  4. Health related quality of life [ Time Frame: 6 months ]
    Measured by COPD Assessment TEST (CAT)

  5. Dyspnea [ Time Frame: 6 months ]
    Measured by Medical Respiratory Council (MRC) dyspnea scale

  6. Exercise performance [ Time Frame: 6 months ]
    Composite measure by Incremental Shuttle Walk Test (ISWT) and Endurance Shuttle Walk Test (ESWT)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients admitted to hospital with acute exacerbation of COPD to Department Respiratory Medicine, Gentofte Hospital
  • Verified diagnosis of COPD FEV1/FVC <70 % in stable phase.
  • Expected discharge to their own home.
  • Minimal of 10 meters walking distance independently
  • Oral and written consent
  • Age > 18 year

Exclusion Criteria:

  • Life expectancy <6 months due to another illness (cancer, severe heart disease, etc.)
  • Difficulties in understanding and speaking Danish (eg. due to dementia)
  • Place of residence outside Gentofte Hospital admission area

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02987439


Contacts
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Contact: Torgny Wilcke, MD, ph.d. +45 38673497 Jon.Torgny.Wilcke@regionh.dk
Contact: Jakob Kjærgaard, MD +45 23254125 jakob@naj.dk

Locations
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Denmark
Dept. of Respiratory medicine, UH Gentofte Recruiting
Hellerup, Denmark, DK-2900
Contact: Torgny Wilcke, MD, ph.d.    +45 38673497    Jon.Torgny.Wilcke@regionh.dk   
Contact: Jakob L Kjærgaard, MD    +45 23254125    jakob.lyngby.kjaergaard.02@regionh.dk   
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen

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Responsible Party: Jon Torgny Wilcke, MD, ph.d., University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT02987439     History of Changes
Other Study ID Numbers: H-2-2013-143
First Posted: December 9, 2016    Key Record Dates
Last Update Posted: December 9, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jon Torgny Wilcke, University Hospital, Gentofte, Copenhagen:
COPD
Exacerbation
Rehabilitation

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases