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

• ClinicalTrials.gov Identifier: NCT02987439
• Recruitment Status: Completed
• First Posted: December 9, 2016
• Last Update Posted: November 21, 2019
• Sponsor: University Hospital, Gentofte, Copenhagen
• Information provided by (Responsible Party): Jon Torgny Wilcke, University Hospital, Gentofte, Copenhagen

Tracking Information

• First Submitted Date: December 6, 2016
• First Posted Date: December 9, 2016
• Last Update Posted Date: November 21, 2019
• Actual Study Start Date: November 2013
• Actual Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 8, 2016)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 8, 2016)

• All cause mortality and time to death [ Time Frame: 12 months ]
• All cause hospital readmission and time to readmission [ Time Frame: 12 months ]
  Proportion of patients with at least 1 hospital readmission of any cause
• Hospital readmission by respiratory cause [ Time Frame: 12 months ]
• Health related quality of life [ Time Frame: 6 months ]
  Measured by COPD Assessment TEST (CAT)
• Dyspnea [ Time Frame: 6 months ]
  Measured by Medical Respiratory Council (MRC) dyspnea scale
• Exercise performance [ Time Frame: 6 months ]
  Composite measure by Incremental Shuttle Walk Test (ISWT) and Endurance Shuttle Walk Test (ESWT)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Chronic Obstructive Lung Disease

Intervention

Other: Pulmonary rehabilitation

The intervention is pulmonary rehabilitation

Study Arms

• 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

  Intervention: Other: Pulmonary rehabilitation

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 8, 2016): 150
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 2018
• Actual Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark

Administrative Information

• NCT Number: NCT02987439
• Other Study ID Numbers: H-2-2013-143
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Jon Torgny Wilcke, University Hospital, Gentofte, Copenhagen
• Study Sponsor: University Hospital, Gentofte, Copenhagen
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University Hospital, Gentofte, Copenhagen
• Verification Date: November 2019