The Additional Value of Noninvasive Ventilation Next to Rehabilitation in Hypercapnic COPD Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Groningen Research Institute for Asthma and COPD.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
The Netherlands Asthma Foundation
Information provided by:
Groningen Research Institute for Asthma and COPD
ClinicalTrials.gov Identifier:
NCT00135538
First received: August 25, 2005
Last updated: April 4, 2007
Last verified: April 2007
  Purpose

The purpose of this study is to investigate whether noninvasive ventilation by nose mask during the night has additional benefits next to pulmonary rehabilitation in patients with severe hypercapnic COPD.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Device: Noninvasive positive pressure ventilation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Does Chronic Ventilatory Support Improve the Outcomes of Rehabilitation in Hypercapnic COPD Patients?

Resource links provided by NLM:


Further study details as provided by Groningen Research Institute for Asthma and COPD:

Primary Outcome Measures:
  • Health related quality of life measured by the Chronic Respiratory Questionnaire

Secondary Outcome Measures:
  • Activities of daily Living
  • Dyspnea (Medical Research Council Scale [MRC], baseline dyspnea index [BDI], Borg)
  • Exercise tolerance (Cycle ergometer test, 6-minute walk distance [6-MWD], incremental shuttle walking test [ISWT], endurance shuttle walking test [ESWT])
  • Pulmonary function testing
  • Sleep quality (polysomnography)
  • Respiratory muscle activity (endurance shuttle walking test [EMG])
  • Respiratory muscle strength (PImax, PEmax)

Estimated Enrollment: 100
Study Start Date: November 2004
Estimated Study Completion Date: April 2009
Detailed Description:

Several randomised controlled trials in patients with stable Chronic Obstructive Pulmonary Disease (COPD) have demonstrated that pulmonary rehabilitation (PR) improves dyspnoea, exercise tolerance, and health-related quality of life. Research in this field has been important in our department for several years. The first study in this respect was started in 1986 comparing outpatient rehabilitation with rehabilitation in the community in patients with severe COPD. This study showed that rehabilitation supervised by a physical therapist in the community is effective for a long period in contrast to outpatient rehabilitation. In 1990 the second study started showing that positive initial benefits of home based rehabilitation on quality of life can be maintained for 18 months if the patients visit the local physical therapist once a month.

However, less positive effects of rehabilitation have been reported in the more severe patients. Because of dyspnoea due to inspiratory muscle fatigue patients may not receive an adequate training stimulus, and therefore rehabilitation might be less effective. In these more severe patients alternative therapies are needed. These non-pharmacological treatments include nutritional supplementation, oxygen therapy, lung transplantation, lung volume reduction surgery and ventilatory support.

The last few years a discussion within the 4 home mechanical ventilation centres (HMV) in the Netherlands has been started about the role of chronic ventilatory support in end-stage COPD. Theoretically, it might be effective because:

  1. a resetting of the respiratory centre may reduce daytime PaCO2;
  2. a better internal milieu (pH, PaO2, PaCO2) may improve peripheral muscle function;
  3. resting the respiratory muscles during the night may increase their daytime strength and endurance;
  4. a reduction in the number of nocturnal arousals may improve the quality of sleep. Nevertheless, none of these mechanisms has been proven and currently there is no evidence that noninvasive positive pressure ventilation (NIPPV) should be given to stable patients with COPD. While several randomised controlled trials (RCT’s) on NIPPV have been published with different outcomes, a recent meta-analysis did not show beneficial effects on blood gasses, lung function, respiratory muscle function and walking distance.

In contrast several uncontrolled studies did show clear benefits from NIPPV on gas-exchange, dyspnoea and quality of life. Possible reasons for these conflicting outcomes are differences in:

  1. selection of patients,
  2. adequacy of ventilatory support,
  3. length of ventilatory support. Interestingly, it seems that studies with a positive outcome included mainly patients with hypercapnia, suggesting this as an important selection criterion.

The hypothesis is that long term NIPPV in hypercapnic patients with COPD may improve the effects of rehabilitation at home regarding health status, ADL function, dyspnoea and exercise tolerance. Secondly, we like to elucidate the exact mechanisms why NIPPV might be effective in this group of patients.

Comparison: patients who receive noninvasive ventilation during the night while following a pulmonary rehabilitation program with patients who only follow a rehabilitation program without receiving the noninvasive ventilation.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • COPD (FEV1< 50%, Tiffeneau < 70%)
  • Dyspnoea on exertion and a reduced exercise capacity
  • Age 75 years or less
  • PaCO2 > 6.0 kPa at rest without oxygen

Exclusion Criteria:

  • Cardial/neuromuscular diseases limiting a successful rehabilitation
  • Obstructive sleep apnoea syndrome: apnea/hypopnea index (AHI) > 10
  • Previous exposure to chronic NIPPV
  • Participation in a pulmonary rehabilitation program less than 18 months ago
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00135538

Locations
Netherlands
University medical Hospital Groningen
Groningen, Netherlands, 9700 RB
Sponsors and Collaborators
Groningen Research Institute for Asthma and COPD
The Netherlands Asthma Foundation
Investigators
Principal Investigator: Marieke L Duiverman University Medical Centre Groningen
  More Information

No publications provided by Groningen Research Institute for Asthma and COPD

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00135538     History of Changes
Other Study ID Numbers: RECOVER1
Study First Received: August 25, 2005
Last Updated: April 4, 2007
Health Authority: Netherlands: Independent Ethics Committee

Keywords provided by Groningen Research Institute for Asthma and COPD:
Pulmonary Disease, Chronic Obstructive
Intermittent Positive-Pressure Ventilation
Rehabilitation

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

ClinicalTrials.gov processed this record on October 29, 2014