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Non Invasive Mechanical Ventilation Versus Respiratory Rehabilitation in Hypercapnic COPD

This study has been completed.
Sponsor:
Collaborator:
Fondo de Investigacion Sanitaria
Information provided by:
Hospitales Universitarios Virgen del Rocío
ClinicalTrials.gov Identifier:
NCT01377818
First received: June 16, 2011
Last updated: June 20, 2011
Last verified: March 2006
History of Changes
  Purpose

Objective: To analyze the additional benefits of exercise training application by the non-invasive home mechanical ventilation in patients with stable COPD and hypercapnic respiratory failure. SUBJECT: moderate-severe COPD (FEV1 <60%) in chronic respiratory failure (hypoxemia and hypercapnia PaCO2> 45mmHg). GROUPS: 45 patients included prospectively and randomly into 3 groups of 15: a) training + NIPPV group, b) Group training, c) Group NIPPV. Hypothesis: A training program to the effort associated with treatment with NIPPV significantly increase the effects compared with each treatment. MAIN OBJETIVE: Effects on exercise capacity as measured by the test of endurance cycling and test 6-minute walk (distance). SECONDARY OBJECTIVES: Impact on quality of life and dyspnea, as measured by questionnaire and CRQ, systemic inflammatory response (CRP, IL-8, TNF-α), changes in peripheral muscle strength (1RM test, isometric) and effects score BODE index.


Condition Intervention Phase
Lung, Hyperlucent
Positive-Pressure Respiration, Intrinsic
 Procedure: ventilation
Procedure: excecise training
Procedure: Both
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Prospective Aleatory Study of Non Invasive Mechanical Ventilation Versus Respiratory Rehabilitation in Hypercapnic Stable Severe COPD

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospitales Universitarios Virgen del Rocío:

Primary Outcome Measures:
  • exercise capacity [ Time Frame: baseline and end of follow-up period (15 weeks) ] [ Designated as safety issue: No ]
    Our primary objective is to verify the beneficial effect on exercise capacity of an exercise training program combined with treatment of positive pressure ventilation noninvasive against each of them separately, in patients with COPD. The improvement in exercise capacity will be assessed by increased resistance time (submaximal exercise test) and distance (test 6-minute walk)


Secondary Outcome Measures:
  • Peripheral muscle strength [ Time Frame: baseline and end of follow-up period (15 weeks) ] [ Designated as safety issue: No ]

    As secondary objectives, we compare the contributions of the combined treatment of:

    a. Peripheral muscle strength (1RM test, maximal isometric strength by dynamometer) and exchange of gases (ABG)


  • quality of life [ Time Frame: baseline and end of follow-up period (15 weeks) ] [ Designated as safety issue: No ]
    Impact on symptoms and quality of life (RCMH, CRQ)

  • inflammation [ Time Frame: baseline and end of follow-up period (15 weeks) ] [ Designated as safety issue: No ]
    Control of the systemic inflammatory response through: CRP, IL-8 and TNF-α

  • BODE [ Time Frame: baseline and end of follow-up period (15 weeks) ] [ Designated as safety issue: No ]
    BODE index as a sensitive parameter of response to therapeutic intervention in these patients.


Enrollment: 45
Study Start Date: March 2006
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ventilation
Group program of positive pressure ventilation noninvasive
 Procedure: ventilation

positive-pressure breathing bilevel (BiPAP ® Respironics, Inc.) Parameters initially programmed be: IPAP 10 cm H2O, EPAP 4 cmH2O, method ST setting yourself respirations 12 breaths minute. The IPAP was progressively increased to a maximum of 20 cm H2O, depending on patient tolerability, clinical response and arterial oxygen saturation was continuously monitored by pulse oximetry, trying to avoid possible leaks through the mask. It can also supply oxygen through a cannula connected to the mask at a flow rate of 2-4 liters per minute to maintain oxygen saturation at around 85-90%.

Patients aired uninterruptedly during nighttime (minimal between 6-8 hours night).

Other Name: Non invasive positive ventilation
Experimental: exercise training

The training program (trained group) was carried out for 12 weeks and sessions of 40 minutes duration:

d. 20 minutes of bicycle ergometer with an initial charge of about 70% of initial maximal oxygen consumption, increasing the load every two weeks as tolerated.

e. Weightlifting in 2 sets of 6 replicates of 5 simple exercises. These are held at a station multigimnástica (CLASSIC Fitness Center, KETTLER)

 Procedure: excecise training

The training program (trained group) was carried out for 12 weeks and sessions of 40 minutes duration:

  • 20 minutes of bicycle ergometer with an initial charge of about 70% of initial maximal oxygen consumption, increasing the load every two weeks as tolerated.
  • Weightlifting in 2 sets of 6 replicates of 5 simple exercises. These are held at a station multigimnástica (CLASSIC Fitness Center, KETTLER)
Other Name: pulmonary rehabilitation
Experimental: exercise training and ventilation
Group of exercise training program and noninvasive positive pressure ventilation
 Procedure: Both
both types of intervention
Other Name: ventilation and exercise

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  Eligibility

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients diagnosed with COPD (Chronic Obstructive Pulmonary Disease)
  2. airflow obstruction with an FEV1 <60%
  3. clinical stability, at least last 3 months
  4. Chronic respiratory failure with hypoxemia and hypercapnia (PaCO2> 45 mmHg)

Exclusion Criteria:

  1. Presence of musculoskeletal condition that limits or prevents the completion of the exercises.
  2. Presence of heart disease that prevents the physical exercise.
  3. Patients with bronchiectasis or other respiratory disorder other than COPD
  4. inability or discomfort to participate in the exercise or non-invasive ventilation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01377818

Sponsors and Collaborators
Hospitales Universitarios Virgen del Rocío
Fondo de Investigacion Sanitaria
Investigators
Principal Investigator: Eduardo Marquez, MD Hospital Universitario Virgen del Rocio
  More Information

No publications provided

Responsible Party: Eduardo Márquez martín, Neumología Hospital Virgen del Rocío
ClinicalTrials.gov Identifier: NCT01377818     History of Changes
Other Study ID Numbers: 01/0530, COPD15081978
Study First Received: June 16, 2011
Last Updated: June 20, 2011
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Hospitales Universitarios Virgen del Rocío:
COPD
Exercise trainig

Additional relevant MeSH terms:
Hypercapnia
Positive-Pressure Respiration, Intrinsic
Lung, Hyperlucent
Signs and Symptoms, Respiratory
Signs and Symptoms
 Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Pulmonary Emphysema
Lung Diseases

ClinicalTrials.gov processed this record on May 19, 2013