Clinical trial NCT02987439: COPD-EXA-REHAB. Early Pulmonary Rehabilitation of Patients With Acute Exacerbation of COPD
Official title: COPD-EXA-REHAB. Early Pulmonary Rehabilitation of Patients With Acute Exacerbation of COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Lung Disease
Keywords: COPD
Exacerbation
Rehabilitation
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2016-12-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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

Eligibility 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

Primary outcomes:
measure: Composite outcome of 1 year mortality or hospital readmission
timeFrame: 12 months
Secondary outcomes:
measure: All cause mortality and time to death
timeFrame: 12 months
measure: All cause hospital readmission and time to readmission
timeFrame: 12 months
measure: Hospital readmission by respiratory cause
timeFrame: 12 months
measure: Health related quality of life
timeFrame: 6 months
measure: Dyspnea
timeFrame: 6 months
measure: Exercise performance
timeFrame: 6 months
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Dept. of Respiratory medicine, UH Gentofte
Study officials:
References: