Skip to main content
OpenTrials
Completed

NCT Number: NCT03936348

Effects of an Exercise Rehabilitation Programme With a Nasal Inspiratory Restriction Device in COPD Patients

This study evaluates the effects of a nasal restriction device for inspiratory muscle training (FeelBreathe) after 8 weeks of exercise intervention on exercise capacity, quality of life, dyspnea and inspitarotory muscle strength in patients with stable COPD. Participants were divided in three groups: 1) exercise intervention using the Feelbreathe® device (FB group), 2) exercise intervention with oronasal breathing without FB (ONB group) and 3) no participation in the exercise intervention as control group (CG).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pulmonary Disease, Chronic Obstructive Breathing Exercises Chronic Disease Disease Attributes Exercise Tolerance Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

35 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

The Feelbreathe® device, tested in the investigator's study can be used in static and dynamic situations and is a nasal ventilatory flow restriction device made by a strip of hypoallergenic material (3M Spain, S.A. Medical Specialties / O.E.M.) that is placed and adhered under the nostrils impairing the free pass of air through the nose by producing resistance to flow. Depend on the size or/and porosity of the device, the inspiratory process is more or less difficult. It can be used while performing dynamic exercise or doing daily living activities. The Feelbreathe® device (FB) has been authorized by the Spanish Agency for Medicines and Health Products for application on COPD patients (Expedient 521/15/EC. AEMPS-Madrid-Spain-Patent Nº: P200902402).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • men with diagnosis of COPD according to guidelines criteria
  • with moderate or severe airflow obstruction (GOLD 2 or 3)
  • dyspnea grade 2 or greater by mMRC scale
  • stable clinical condition for at least 2 months.

Exclusion criteria

  • poor compliance
  • treatment with oxygen therapy or non-invasive mechanical ventilation
  • CO2 retention
  • medical conditions that can produce or increase dyspnea on exercise in addition to COPD (cardiovascular, metabolic or other respiratory diseases)
  • osteoarticular or neuromuscular diseases that may limit the correct performance of the 6MWT

Treatment and study plan

Exercise training program with and without FB

Device

Participants carried out a supervised RP for 8 weeks, 3 days per week. The training sessions lasted 60 minutes and included a warning up phase, the main phase and a recovery phase. After each session, Borg's perceived exertion was measured. The Rehabilitation Program (RP) included aerobic exercise on cycle ergometer and on treadmill (progressing since 10' to 30' and since 40 to 75% of the reserve heart rate (RHR) or 6-7 score based on Borg's perceived exertion), strengthening of lower and upper limb muscles groups, breathing exercises (pursed lip breathing, diaphragmatic and abdominal breathing and diaphragmatic mobility) and finally stretching exercises.

In the FB group, for restricted nasal breathing, at the beginning of the training program, the small size device was used (4 mm). The size of the device was progressively increasing according to the patient adaptation to the 5 or 6 mm device, depending on the score on Borg's perceived exertion scale.

Other names: Pulmonary rehabilitation program

Primary outcomes

  1. Oxygen uptake during incremental test to exhaustion on treadmill

    Time frame: 8 WEEKS

    mL/min

  2. Ventilation during incremental test to exhaustion on treadmill

    Time frame: 8 WEEKS

    L/min

Secondary outcomes

  1. dyspnea scale

    Time frame: 8 WEEKS

    mMRC (Modified Medical Research Council) Dyspnea Scale. Values from 0 (better) to 4 (worse) about disability attributable to breathlessness

  2. The COPD Assessment Test (CAT) is a questionnaire for people with Chronic Obstructive Pulmonary Disease (COPD)

    Time frame: 8 WEEKS

    The COPD Assessment Test (CAT) score measures the impact that COPD (Chronic Obstructive Pulmonary Disease) is having on the wellbeing and daily life of the patient. Score from 0 (better) to 40 (worse) about the impact of COPD symptoms on patients' overall health.

  3. exercise capacity using the distance walked in the six minutes walking test (6MWT)

    Time frame: 8 WEEKS

    distance measured in meters

Sponsors and collaborators

Lead sponsor

University of Cadiz

Other

Collaborators

  • Bahía Sur Andalusian Center for Sports Medicine
  • Hospital Universitario Puerta del Mar
  • Sociedad Española de Neumología y Cirugía Torácica

Registry information

Official study title

Evaluation of a Respiratory Muscle Training Program Restricting Nasal Breathing With FeelBreathe® Device in COPD Patients

Acronym: EPOC_2_0

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 3, 2019
Registry last updated
May 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.