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Effects of an Exercise Rehabilitation Programme With a Nasal Inspiratory Restriction Device in COPD Patients (EPOC_2_0)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03936348
Recruitment Status : Completed
First Posted : May 3, 2019
Last Update Posted : May 31, 2019
Sponsor:
Collaborators:
Sociedad Española de Neumología y Cirugía Torácica
University Hospital Puerta del Mar
Bahía Sur Andalusian Center for Sports Medicine
Information provided by (Responsible Party):
Jesus Gustavo Ponce González, University of Cadiz

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Breathing Exercises Exercise Tolerance Device: Exercise training program with and without FB Not Applicable

Detailed Description:
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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: Patients were randomized to 3 groups. The first one performed a supervised RP using the Feelbreathe® device (FB group), the second group developed the same RP with oronasal breathing without FB (ONB group) and the third was the control group (CG). The RP was conducted during 8 weeks, 3 days per week, and includes a combined training of endurance and strength exercises.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of a Respiratory Muscle Training Program Restricting Nasal Breathing With FeelBreathe® Device in COPD Patients
Actual Study Start Date : January 15, 2016
Actual Primary Completion Date : July 25, 2017
Actual Study Completion Date : December 18, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: FB group
Participants who performed an exercise training program for 8 weeks using a nasal restriction device for inspiratory muscle training, called Feelbreathe®
Device: Exercise training program with and without FB

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 Name: Pulmonary rehabilitation program

Experimental: ONB group
Participants who performed an exercise training program for 8 weeks with oronasal breathing without FB
Device: Exercise training program with and without FB

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 Name: Pulmonary rehabilitation program

No Intervention: control group (CG)
Participants who received the standard medical recommendations for patients with COPD, but not participated in the exercise intervention program



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03936348


Sponsors and Collaborators
University of Cadiz
Sociedad Española de Neumología y Cirugía Torácica
University Hospital Puerta del Mar
Bahía Sur Andalusian Center for Sports Medicine
Investigators
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Principal Investigator: Jose L González Montesinos, PhD University of Cádiz
  Study Documents (Full-Text)

Documents provided by Jesus Gustavo Ponce González, University of Cadiz:
Publications of Results:
Other Publications:
González-Montesinos JL, Vaz Pardal C, Fernández Santos JR, Arnedillo Muñoz A CSJ y GE de los MR. Efectos del entrenamiento de la musculatura respiratoria sobre el rendimiento. Revisión bibliográfica. Rev Andal Med Deport. 2012;5(4):163-70.

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Responsible Party: Jesus Gustavo Ponce González, Principal Investigator, University of Cadiz
ClinicalTrials.gov Identifier: NCT03936348    
Other Study ID Numbers: (SEPAR): CÓDIGO: 099/2015
First Posted: May 3, 2019    Key Record Dates
Last Update Posted: May 31, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Since there is personal and not transferable data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jesus Gustavo Ponce González, University of Cadiz:
Pulmonary rehabilitation
Medical device
FeelBreathe
Exercise intervention
Equipment and Supplies
Additional relevant MeSH terms:
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Respiratory Aspiration
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Pathologic Processes
Lung Diseases, Obstructive