Effect of Exercise Training Under HFO Device on Endurance Tolerance in Patients With COPD and CRF: a Randomized Controlled Study.

Summary

Current literature clearly shows the benefit of pulmonary rehabilitation in symptomatic COPD (Trooster,2005). However, these patients are frequently unable to sustain a work-load sufficiently high to obtain a full benefit on exercise tolerance (Trooster,2005). Especially in patients with Chronic Respiratory Failure (CRF), the development of hypoxia (O'Donnel,2001) and the increase of dead space (Elbehairy,2015) during effort explain the out-of-proportion increase in ventilation leading to an early achievement of the ventilatory reserve. Recent studies on heated and humidified high flow oxygen (HFO) delivered through nasal cannula, show several positive effects on breathing pattern and ventilatory efficiency, mostly in critical care setting and at rest (Spoletini,2015). Some recent physiological studies have evidenced that high flows of humidified oxygen improve exercise performance in patients with COPD and severe oxygen dependency, in part by enhancing oxygenation (Chatila,2004). Recently, a pilot study by our group showed that HFO may improve the exercise performance in severe COPD patients with ventilatory limitation. This effect is associated to an improvement of oxygen saturation (SatO2) and perceived symptoms at iso-time (Cirio,2016). No clinical studies are available about the use of HFO during exercise training. The investigators hypothesize that, in severe COPD patients with CRF and exercise limitation , the use of HFO could improve the efficiency of ventilation, leading to an increase in the patient's exercise performance and outcome.

Primary aim will be to evaluate in patients COPD with CRF the difference in the endurance tolerance improvement (expressed in minutes) after an high intensity training program, at iso-FiO2, using HFO with respect to usual oxygen administration by " Venturi Mask" .

Secondary objectives will be to study effectiveness of HFO with respect to "Venturi Mask" in terms of improvement of meters of 6 Minute Walking Test, dyspnea at rest, peripheral and respiratory muscle strength,blood gases, motor and respiratory disability,quality of life,impact of the disease and patients satisfaction.

Conditions

• COPD

Interventions

DEVICE

HFO

Training will be done using the HFO device. Air-flow will set at the highest value tolerated by the patients, until a maximum value of 60 l/min permitted and FiO2 set during the run-in. The HFO will be administered using the AIRVO2® (Fisher\&Paykel- NewZealand). Afterwards, the oxygen flow provided into the system will be progressively increased until the pre-fixed FiO2 will be reached, as displayed by the AIRVO2 monitor.

Sponsors & Collaborators

• Azienda Ospedaliera Ospedale Maggiore di Crema

  collaborator OTHER

• University of Modena and Reggio Emilia

  collaborator OTHER

• Villa Pineta Hospital

  collaborator OTHER

• Fisher and Paykel Healthcare

  collaborator INDUSTRY

• Associazione Riabilitatori Insufficienza Respiratoria

  collaborator OTHER

• Istituti Clinici Scientifici Maugeri SpA

  lead OTHER

Principal Investigators

• Michele Vitacca, MD · ICS Maugeri Lumezzane

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-11-06

Primary Completion

2018-12-08

Completion

2019-03-31

Countries

• Italy

Study Locations