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

NCT03936348 | Completed

• 1 other identifier: (SEPAR): CÓDIGO: 099/2015
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Pulmonary Disease, Chronic Obstructive; Breathing Exercises; Exercise Tolerance

Keywords

Pulmonary rehabilitation; Medical device; FeelBreathe; Exercise intervention; Equipment and Supplies

Outcome Measures

Primary Outcomes (2)

• Oxygen uptake during incremental test to exhaustion on treadmill

  mL/min

  8 WEEKS

• Ventilation during incremental test to exhaustion on treadmill

  L/min

  8 WEEKS

Secondary Outcomes (3)

• dyspnea scale

  8 WEEKS

• The COPD Assessment Test (CAT) is a questionnaire for people with Chronic Obstructive Pulmonary Disease (COPD)

  8 WEEKS

• exercise capacity using the distance walked in the six minutes walking test (6MWT)

  8 WEEKS

Study Arms (3)

FB group

EXPERIMENTAL

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

ONB group

EXPERIMENTAL

Participants who performed an exercise training program for 8 weeks with oronasal breathing without FB

Device: Exercise training program with and without FB

control group (CG)

NO INTERVENTION

Participants who received the standard medical recommendations for patients with COPD, but not participated in the exercise intervention program

Interventions

Exercise training program with and without FB DEVICE

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.

Also known as: Pulmonary rehabilitation program

FB group; ONB group

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cadiz: lead
• Sociedad Española de Neumología y Cirugía Torácica: collaborator
• Hospital Universitario Puerta del Mar: collaborator
• Bahía Sur Andalusian Center for Sports Medicine: collaborator

Related Publications (6)

• González-Montesinos JL, Vaz Pardal C, Fernández Santos JR, Arnedillo Muñoz A CSJ y GE de los MR. Efectos del entrenamiento de la musculatura respiratoria sobre el rendimiento. Revisión bibliográfica. Rev Andal Med Deport. 2012;5(4):163-70.

  BACKGROUND

• González Montesinos JL, Costa Sepúlveda JL, Fernández Santos J, Gómez Espinosa de los Monteros R, Mora Vicente J, Castro Piñero J y, et al. Dispositivo de Restricción y Filtrado del Flujo Ventilatorio Nasal. P200902402, 2011. p. 1-4.

  RESULT

• Gonzalez-Montesinos JL, Ponce-Gonzalez JG, Vicente-Campos D, Lopez-Chicharro J, Fernandez-Santos Jdel R, Vaz-Pardal C, Costa-Sepulveda JL, Conde-Caveda J, Castro-Pinero J. Efectos de un dispositivo de restriccion ventilatoria nasal sobre la ventilacion pulmonar e intercambio gaseoso durante el ejercicio en personas sanas. Nutr Hosp. 2016 Mar 25;33(2):130. doi: 10.20960/nh.130.

  PMID: 27238811 RESULT

• Scherer TA, Spengler CM, Owassapian D, Imhof E, Boutellier U. Respiratory muscle endurance training in chronic obstructive pulmonary disease: impact on exercise capacity, dyspnea, and quality of life. Am J Respir Crit Care Med. 2000 Nov;162(5):1709-14. doi: 10.1164/ajrccm.162.5.9912026.

  PMID: 11069801 RESULT

• Wada JT, Borges-Santos E, Porras DC, Paisani DM, Cukier A, Lunardi AC, Carvalho CR. Effects of aerobic training combined with respiratory muscle stretching on the functional exercise capacity and thoracoabdominal kinematics in patients with COPD: a randomized and controlled trial. Int J Chron Obstruct Pulmon Dis. 2016 Oct 28;11:2691-2700. doi: 10.2147/COPD.S114548. eCollection 2016.

  PMID: 27822031 RESULT

• Camillo CA, Osadnik CR, van Remoortel H, Burtin C, Janssens W, Troosters T. Effect of "add-on" interventions on exercise training in individuals with COPD: a systematic review. ERJ Open Res. 2016 Mar 29;2(1):00078-2015. doi: 10.1183/23120541.00078-2015. eCollection 2016 Jan.

  PMID: 27730178 RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jose L González Montesinos, PhD

  University of Cádiz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 28, 2019
• First Posted: May 3, 2019
• Study Start: January 15, 2016
• Primary Completion: July 25, 2017
• Study Completion: December 18, 2017
• Last Updated: May 31, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share