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

NCT02987439 | Completed DMC

• 1 other identifier: H-2-2013-143
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Obstructive Lung Disease

Keywords

COPD; Exacerbation; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Composite outcome of 1 year mortality or hospital readmission

  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.

  12 months

Secondary Outcomes (6)

• All cause mortality and time to death

  12 months

• All cause hospital readmission and time to readmission

  12 months

• Hospital readmission by respiratory cause

  12 months

• Health related quality of life

  6 months

• Dyspnea

  6 months

Study Arms (2)

Standard care group

NO INTERVENTION

* 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

Rehabilitation group

EXPERIMENTAL

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

Interventions

Pulmonary rehabilitation OTHER

The intervention is pulmonary rehabilitation

Rehabilitation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Gentofte, Copenhagen: lead

Study Sites (1)

Dept. of Respiratory medicine, UH Gentofte

Hellerup, DK-2900, Denmark

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Pricipal Investigator

Study Record Dates

• First Submitted: December 6, 2016
• First Posted: December 9, 2016
• Study Start: November 1, 2013
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: November 21, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)