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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

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

Clinicaltrials.gov identifier NCT03936348

Recruitment Status Completed

First Posted May 3, 2019

Last update posted May 31, 2019

Study Description

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:Pulmonary Disease, Chronic Obstructive
    Breathing Exercises
    Exercise Tolerance
  • Intervention/Treatment: Device: Exercise training program with and without FB
  • Phase: N/A
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 Design
  • Study Type: Interventional
  • 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 2016
  • Actual Primary Completion Date: July 2017
  • Actual Study Completion Date: December 2017
Arms and interventions
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.
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.
Outcome Measures
  • 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
Eligibility Criteria
  • Ages Eligible for Study: 35 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

Contacts and Locations
Contacts
Locations
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

Principal Investigator: Jose L González Montesinos, PhD University of Cádiz

More Information