Effects of an Exercise Rehabilitation Programme With a Nasal Inspiratory Restriction Device in COPD Patients
Condition: Pulmonary Disease, Chronic Obstructive; Breathing Exercises; Exercise Tolerance
MeSH terms: Respiratory Aspiration; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

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).
    

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).
    

Intervention name(s): Exercise training program with and without FB
Intervention type(s): Device
Intervention description(s): 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 intervention name(s): Pulmonary rehabilitation program
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
Keywords: Pulmonary rehabilitation; Medical device; FeelBreathe; Exercise intervention; Equipment and Supplies