Non Invasive Mechanical Ventilation in Chronic Respiratory Insufficiency Patients During Rehabilitation

November 12, 2015 updated by: Michele Vitacca, Fondazione Salvatore Maugeri

Evaluation of the Additional Effect of Non Invasive Mechanical Ventilation During a Rehabilitative Program With Cycloergometer in Patients With Chronic Respiratory Insufficiency Using Nocturnal Home Ventilation

Patients with Chronic Obstructive Pulmonary Disease (COPD) and chronic respiratory insufficiency (CRI) have severe dyspnoea during exercise at low load. Physiological studies performed in these patients during a unique session of training have shown a positive effect on exercise tolerance if non-invasive mechanical ventilation (NIV) was added during incremental effort test or endurance. Menadue and coworkers (2009) have shown in CRI patients with hypercapnia, secondary to COPD or cifoscoliosis, that combination of NIV during arm effort test improved ability to perform the exercise. Similar result was not reached using NIV during walking. Further studies have underlined a positive effect of the ventilation therapy during exercise within specific programs of pulmonary rehabilitation (Corner 2009). Moreover, the addition of NIV to an exercise training (ET) program in COPD patients may produce greater benefits in exercise tolerance and quality of life than exercise training alone (Garrod 2000).

A great improvement in health-related quality of life, functional status and gas exchange in COPD patients with chronic hypercapnic respiratory failure with nocturnal NIV compared with patients in pulmonary rehabilitation alone has been also shown by Duieverman (2008). However, in the same study Duieverman did not show any significant difference between groups in terms of tolerance to effort test.

Aim of the study is to evaluate if application of daily NIV during physical training may increase the benefits of rehabilitation in CRI patients with nocturnal NIV compared with patients with nocturnal NIV performing training under spontaneous breathing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

INTERVENTION

Group 1 (NIV during training + nocturnal NIV): This group of patients will use the usual NIV during night and will perform a rehabilitative program of at least 20 sessions of training at cycloergometer under NIV.

NO INTERVENTION

Group 2 (training in Spontaneous Breathing [SB] + nocturnal NIV): This group of patients will use the usual NIV during night and will be trained in a rehabilitative daily program without NIV. This group will be considered the "control" group.

Sessions: 30 minutes/session, 2 times/day, 4-5 times a week for a total of 20-25 session in 3 weeks.

Intensity: each patient will start at 50% of each individual's maximum work capacity (cycloergometer) increasing up to the maximum tolerated, according to Maltais's protocol.

NIV SETTING:

Training: Facial mask with usual setting (Inspiratory Positive Airway Pressure [IPAP] 10-15; Expiratory Positive Airway Pressure [EPAP] 4-6 cmH20) with a possible adjustment in agreement with the comfort.

The adjustment of ventilation during training will be only within the first 3 sessions according to the following protocol:

COPD patients: increase up to 3 cmH2Os of EPAP and decrease up to 3 cmH2Os of IPAP.

Restricted patients: increase up to 3 cmH2Os of IPAP.

Nocturnal ventilation: mask and usual setting

The primary outcome of the study is evaluation of effort tolerance measured by 6 minutes Walking Test (6-min Walking Test). The hypothesis is to verify a percentage of variation between the two groups equal to 10% after the rehabilitative program. To get a study power of 80% and an alpha error <5% 25 patients for group had to be enrolled.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Brescia
      • Lumezzane, Brescia, Italy, 25065
        • Fondazione Salvatore Maugeri

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 79 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A total of 50 patients aging 40-79 years will be enrolled ( 8 out of 50 will be from FSM in Lumezzane)
  • Patients with chronic respiratory insufficiency (CRI) in treatment with nocturnal NIV from at least six months;
  • Clinical stability (absence of disease re-exacerbations from at least 4 weeks before the study).

Exclusion Criteria:

  • Cardiac diseases: unstable and/or exercise angina, congestive heart failure cardiac, uncontrolled cardiac arrhythmias, sinus tachycardia at rest (HR >120 bpm), hypertension at rest and/or during effort not adequately checked by therapy
  • Orthopaedic and/or neuromuscular illnesses.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Rehabilitation without NIV
A usual rehabilitative training will be performed in patients using nocturnal NIV, without adoption of daily NIV
Other: Rehabilitation without NIV
Training in patients without NIV adoption
Other Names:
  • Group 2
  • No intervention
EXPERIMENTAL: Daily NIV during rehabilitation
Daily NIV will be adopted during the rehabilitation program in patients already using nocturnal NIV
Other: Daily NIV during rehabilitation
Addition of non invasive mechanical ventilation (NIV) during daily rehabilitation in patients using nocturnal NIV
Other Names:
  • Group 1
  • Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effort tolerance measured by 6-minutes Walking test
Time Frame: After 3 weeks
Changes from baseline in 6-minutes Walking test
After 3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximal Inspiratory Pressure/Maximal Expiratory Pressure
Time Frame: After 3 weeks
After 3 weeks
Quality of life MRF 28
Time Frame: After 3 weeks
After 3 weeks
Gas analysis
Time Frame: After 3 weeks
After 3 weeks
Effort tolerance evaluated by 6-minutes walking test
Time Frame: After 3 weeks
Changes in 6-minutes walking test evaluated at the end of the program
After 3 weeks
Endurance at cycloergometer test
Time Frame: After 3 weeks
After 3 weeks
Effort tolerance measured by 6-minutes Walking test
Time Frame: Follow up at 3 months after the end of the protocol
Changes in 6-minutes Walking test evaluated 3 months after the end of the protocol
Follow up at 3 months after the end of the protocol

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Salvatore Maugeri

Collaborators

Azienda Ospedaliero, Universitaria Pisana
Ataturk Training and Research Hospital

Investigators

  • Principal Investigator: Michele Vitacca, MD, Fondazione Salvatore Maugeri

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (ACTUAL)

June 1, 2015

Study Completion (ACTUAL)

October 1, 2015

Study Registration Dates

First Submitted

October 12, 2011

First Submitted That Met QC Criteria

October 21, 2011

First Posted (ESTIMATE)

October 24, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

November 13, 2015

Last Update Submitted That Met QC Criteria

November 12, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTS/10/01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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