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

NCT03936348 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2019-05-31

No results posted yet for this study

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).

Conditions

  • Pulmonary Disease, Chronic Obstructive
  • Breathing Exercises
  • Exercise Tolerance

Interventions

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.

Sponsors & Collaborators

  • Sociedad Española de Neumología y Cirugía Torácica

    collaborator OTHER

  • Hospital Universitario Puerta del Mar

    collaborator OTHER

  • Bahía Sur Andalusian Center for Sports Medicine

    collaborator UNKNOWN

  • University of Cadiz

    lead OTHER

Principal Investigators

  • Jose L González Montesinos, PhD · University of Cádiz

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
35 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-15
Primary Completion
2017-07-25
Completion
2017-12-18

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03936348 on ClinicalTrials.gov