Overview

This trial is active, not recruiting.

Condition chronic obstructive pulmonary disease
Treatment feel breathe, restriction device ventilatory nasal in copd
Sponsor University of Cadiz
Collaborator Fondo Europeo de Desarrollo Regional
Start date February 2012
End date June 2012
Trial size 15 participants
Trial identifier NCT01695265, AC26392COPD

Summary

Using the FEELBREATHE®, a nasal ventilatory restriction device, during an exercise test in treadmill, produce physiological changes in patients with Chronic Obstructive Pulmonary Disease (COPD).

These changes may improve strength and endurance of the inspiratory muscles and improve exercise tolerance in these patients.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking single blind (subject)
Primary purpose basic science
Arm
(Experimental)
15 patients diagnosed of Chronic Obstructive Pulmonary Disease (COPD) at least 6 months before, with a forced expiratory volume in the first second (FEV1) between 70 and 30% of predicted value. Subjects who provide informed consent and meet all of the inclusion criteria and none of the exclusion criteria will be randomized. The investigators excluded patients who have had an exacerbation in the two months prior to inclusion, patients with concomitant diseases that may cause or contribute to dyspnea on exertion (cardiovascular, metabolic or other respiratory diseases associated) or diseases that could interfere the performance of the exercise test (basically neuromuscular and skeletal diseases).
feel breathe, restriction device ventilatory nasal in copd
Device: Feel Breathe, restriction device ventilatory nasal The Feel Breathe (FB) consisted of a small adhesive strip that is place across the bridge of the nose during exercise. The FB was place following procedures for placement as indicated by the manufacture's directions, while the placebo nasal, was placed over the nostrils of the subject, without interfering nasal breathing; thus, nasal airflow resistance was not increase. Each subjet was required to perform three identical submaximal exercises with intensity at 65% of VO2 Peak achieve during a first incremental cardiopulmonary exercise test CPET

Primary Outcomes

Measure
Overall impact of a restriction device ventilatory nasal over different physiological variables in COPD
time frame: Subjects were assessed during 8 weeks

Secondary Outcomes

Measure
Maximal Oxygen uptake
time frame: Subjects were assessed during 8 weeks
Maximum static inspiratory pressure (PImax)
time frame: Subjects were assessed during 8 weeks

Eligibility Criteria

Male or female participants from 40 years up to 70 years old.

Inclusion Criteria: Patients diagnosed of Chronic Obstructive Pulmonary Disease (COPD) at least 6 months before, with a forced expiratory volume in the first second (FEV1) between 70 and 30% of predicted value Exclusion Criteria: - Suffer other illness. - Unwillingness to complete the study requirements. - Cardiovascular diseases (resting electrocardiogram and during exercise). - Elevated resting blood pressure (>130/85 mmHg). All inclusion and exclusion criteria were assessed by a detailed medical history and, where noted, by specific measurements.

Additional Information

Official title Feel Breathe, Restriction Device Ventilatory Nasal (COPD)
Principal investigator José L. González Montesinos, PhD
Trial information was received from ClinicalTrials.gov and was last updated in May 2013.
Information provided to ClinicalTrials.gov by University of Cadiz.