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

May 29, 2019 updated by: Jesus Gustavo Ponce González, University of Cadiz

Evaluation of a Respiratory Muscle Training Program Restricting Nasal Breathing With FeelBreathe® 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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

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: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Oxygen uptake during incremental test to exhaustion on treadmill
Time Frame: 8 WEEKS
mL/min
8 WEEKS
Ventilation during incremental test to exhaustion on treadmill
Time Frame: 8 WEEKS
L/min
8 WEEKS

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
8 WEEKS
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.
8 WEEKS
exercise capacity using the distance walked in the six minutes walking test (6MWT)
Time Frame: 8 WEEKS
distance measured in meters
8 WEEKS

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Cadiz

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Sociedad Española de Neumología y Cirugía Torácica
Hospital Universitario Puerta del Mar
Bahía Sur Andalusian Center for Sports Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jose L González Montesinos, PhD, University of Cadiz

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 25, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 18, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 28, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 31, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • (SEPAR): CÓDIGO: 099/2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Since there is personal and not transferable data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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