Non Invasive Mechanical Ventilation Versus Respiratory Rehabilitation in Hypercapnic COPD

NCT01377818 | Completed Phase 4

• 2 other identifiers: 01/0530COPD15081978
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Lung, Hyperlucent; Positive-Pressure Respiration, Intrinsic

Keywords

COPD; Exercise trainig

Outcome Measures

Primary Outcomes (1)

• exercise capacity

  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)

  baseline and end of follow-up period (15 weeks)

Secondary Outcomes (4)

• Peripheral muscle strength

  baseline and end of follow-up period (15 weeks)

• quality of life

  baseline and end of follow-up period (15 weeks)

• inflammation

  baseline and end of follow-up period (15 weeks)

• BODE

  baseline and end of follow-up period (15 weeks)

Study Arms (3)

ventilation

EXPERIMENTAL

Group program of positive pressure ventilation noninvasive

Procedure: ventilation

exercise training

EXPERIMENTAL

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

exercise training and ventilation

EXPERIMENTAL

Group of exercise training program and noninvasive positive pressure ventilation

Procedure: Both

Interventions

ventilation PROCEDURE

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).

Also known as: Non invasive positive ventilation

ventilation

excecise training PROCEDURE

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)

Also known as: pulmonary rehabilitation

exercise training

Both PROCEDURE

both types of intervention

Also known as: ventilation and exercise

exercise training and ventilation

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Presence of musculoskeletal condition that limits or prevents the completion of the exercises.
• Presence of heart disease that prevents the physical exercise.
• Patients with bronchiectasis or other respiratory disorder other than COPD
• inability or discomfort to participate in the exercise or non-invasive ventilation

Sponsors & Collaborators

• Hospitales Universitarios Virgen del Rocío: lead
• Fondo de Investigacion Sanitaria: collaborator

MeSH Terms

Conditions

Lung, Hyperlucent; Positive-Pressure Respiration, Intrinsic; Pulmonary Disease, Chronic Obstructive

Interventions

Ventilation; Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Environment, Controlled; Environment; Environment and Public Health; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Eduardo Marquez, MD

  Hospital Universitario Virgen del Rocio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 16, 2011
• First Posted: June 21, 2011
• Study Start: March 1, 2006
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: June 21, 2011

Record last verified: 2006-03