Effects of Farinelli's Breathing Exercise in COPD Patients

COPD Patients Clinical Trial

Official title:

Effects of Farinelli's Breathing Exercise on Cardiorespiratory Fitness and Symptoms in COPD Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04869033
• Other study ID #: EX PHYSIO SPSC 2
• Status: Completed
• Phase: N/A
• Start date: January 7, 2020
• Est. completion date: August 27, 2020

Study information

• Verified date: April 2021
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study was to investigate the effect of Farinelli's breathing exercise on pulmonary function, respiratory muscle strength, aerobic capacity, impact of COPD questionnaires, cytokines, and oxidative stress in patients with Chronic Obstructive Pulmonary Disease (COPD).

Description:

Sixteen patients with COPD (GOLD I) with mild and moderate (GOLD II) severity aged 51 - 80 years old who visited at the outpatient examination room, Phramongkutklao Hospital divided into 2 groups; diaphragmatic breathing group (DB; n=8) and Farinelli's breathing group (FB; n=8). Participants in each group were administered to complete breathing exercise 5 times per week for 8 weeks. Physiological data and pulmonary function (FVC, FEV1, PEF, FEV1/FVC, FEF25-75%, MVV, VC, TV, IRV, ERV and IC), respiratory muscle strength (MIP and MEP), aerobic capacity (6-MWD and VO2max), impact of COPD questionnaire (mMRC and CAT), cytokine (TNF-α and IL-6), and oxidative stress (MDA) were analyzed during Pre- and Post-test.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 27, 2020
• Est. primary completion date: August 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 51 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with COPD who treated in Phramongkutklao Hospital
• Have a history of smoking
• FEV1 predicted after bronchodilator more than 50%
• No change in medication in 4 weeks
• No history of acute exacerbation in 4 weeks
• No history of cardiac disease.

Exclusion Criteria:

• Recurrent of acute exacerbation
• Cannot participate at least 80% of training program (= 32 sessions of 40 sessions)
• Unwilling to continue practicing.

Related Conditions & MeSH terms

• COPD Patients
• Respiratory Aspiration

Intervention

Other:
• Farinelli's Breathing Exercise
after 1 minute of normal breathing, follow this instruction; inhale 2 seconds, suspend 2 seconds, exhale 2 seconds. inhale 3 seconds, suspend 3 seconds, exhale 3 seconds. inhale 4 seconds, suspend 4 seconds, exhale 4 seconds. inhale 5 seconds, suspend 5 seconds, exhale 5 seconds. inhale 6 seconds, suspend 6 seconds, exhale 6 seconds. This cycle lasted 1 minute (60 seconds), called Farinelli's breathing (FB). When participants finished these cycle, repeated it again 4 times. 1 minute of NB + 4 minutes of FB called 1 set. The participants were asked to practice 6 sets/day, 5 days/week (Monday-Friday) for week 1-4, and increased duration to 8 sets/day, 5 days/week for week 5-8.
• Diaphragmatic Breathing Exercise
after 1 minute of normal breathing, inhale 2 seconds and exhale 2 seconds with nasal airway. Continued breathing this pattern until 4 minutes, then back to normal breathing 1 minute . 1 minute of NB + 4 minute of DB called 1 set. The participants were asked to practice 6 sets/day, 5 days/week (Monday-Friday) for week 1-4, and increased duration to 8 sets/day, 5 days/week for week 5-8.

Locations

Country	Name	City	State
Thailand	Faculty of Sports Science, Chulalongkorn University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

References & Publications (7)

Barnes PJ. Inflammatory mechanisms in patients with chronic obstructive pulmonary disease. J Allergy Clin Immunol. 2016 Jul;138(1):16-27. doi: 10.1016/j.jaci.2016.05.011. Epub 2016 May 27. Review. — View Citation

Beavers KM, Brinkley TE, Nicklas BJ. Effect of exercise training on chronic inflammation. Clin Chim Acta. 2010 Jun 3;411(11-12):785-93. doi: 10.1016/j.cca.2010.02.069. Epub 2010 Feb 25. Review. — View Citation

Cahalin LP, Braga M, Matsuo Y, Hernandez ED. Efficacy of diaphragmatic breathing in persons with chronic obstructive pulmonary disease: a review of the literature. J Cardiopulm Rehabil. 2002 Jan-Feb;22(1):7-21. Review. — View Citation

Gosselink R. Breathing techniques in patients with chronic obstructive pulmonary disease (COPD). Chron Respir Dis. 2004;1(3):163-72. Review. — View Citation

Holland AE, Hill CJ, Jones AY, McDonald CF. Breathing exercises for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2012 Oct 17;10:CD008250. doi: 10.1002/14651858.CD008250.pub2. Review. — View Citation

Ksinopoulou H, Hatzoglou C, Daniil Z, Gourgoulianis K, Karetsi H. Respiratory function in vocal soloists, opera singers and wind instrument musicians. Med Lav. 2016 Dec 13;107(6):437-443. — View Citation

Leelarungrayub J, Puntumetakul R, Sriboonreung T, Pothasak Y, Klaphajone J. Preliminary study: comparative effects of lung volume therapy between slow and fast deep-breathing techniques on pulmonary function, respiratory muscle strength, oxidative stress, cytokines, 6-minute walking distance, and quality of life in persons with COPD. Int J Chron Obstruct Pulmon Dis. 2018 Dec 5;13:3909-3921. doi: 10.2147/COPD.S181428. eCollection 2018. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Force Vital Capacity (FVC) change	FVC is the total volume of air that can be exhaled during a maximal forced expiration effort. The participants were asked to wear a nose clip while sitting on a chair, and the researcher gave the participants the step-by-step protocol to prevent an incorrect maneuver. For the FVC maneuver, three cycles of slow normal breathing were performed before demonstrating forced inspiration and expiration. FVC is measured in liters.	Change from Baseline Force Vital Capacity at 8 weeks.
Primary	Forced expiratory volume in 1 second (FEV1) change	FEV1 is the volume of air exhaled in the first second under force after a maximal inhalation. The participants were asked to wear a nose clip while sitting on a chair, and the researcher gave the participants the step-by-step protocol to prevent an incorrect maneuver. For the FVC maneuver, three cycles of slow normal breathing were performed before demonstrating forced inspiration and expiration. FEV1 was showed in liters.	Change from Baseline Forced expiratory volume in 1 second at 8 weeks.
Primary	Tidal Volume (TV) change	TV is the volume of air inhaled or exhaled during each respiratory cycle. The participants were asked to wear a nose clip while sitting on a chair, and the researcher gave the participants the step-by-step protocol to prevent an incorrect maneuver. For the FVC maneuver, three cycles of slow normal breathing were performed before demonstrating forced inspiration and expiration. TV is measured in liters.	Change from Baseline Tidal Volume at 8 weeks.
Primary	Inspiratory Reserve Volume (IRV) change	IRV is the maximal volume of air inhaled from end-inspiration. The participants were asked to wear a nose clip while sitting on a chair, and the researcher gave the participants the step-by-step protocol to prevent an incorrect maneuver. For the FVC maneuver, three cycles of slow normal breathing were performed before demonstrating forced inspiration and expiration. IRV is measured in liters.	Change from Baseline Inspiratory Reserve Volume at 8 weeks.
Primary	Expiratory Reserve Volume (ERV) change	ERV is the maximal volume of air exhaled from end-expiration. The participants were asked to wear a nose clip while sitting on a chair, and the researcher gave the participants the step-by-step protocol to prevent an incorrect maneuver. For the FVC maneuver, three cycles of slow normal breathing were performed before demonstrating forced inspiration and expiration. ERV is measured in liters.	Change from Baseline Expiratory Reserve Volume at 8 weeks.
Primary	Inspiratory capacity (IC) change	IC is the amount of air that can be inhaled after the end of a normal expiration. It is, therefore, the sum of the tidal volume and inspiratory reserve volume. The participants were asked to wear a nose clip while sitting on a chair, and the researcher gave the participants the step-by-step protocol to prevent an incorrect maneuver. For the FVC maneuver, three cycles of slow normal breathing were performed before demonstrating forced inspiration and expiration. IC was showed in liters.	Change from Baseline Inspiratory Capacity at 8 weeks.
Primary	Peak Expiratory Flow (PEF) change	PEF is the amount and rate of air that can be forcefully breathed out of the lungs. The participants were asked to wear a nose clip while sitting on a chair, and the researcher gave the participants the step-by-step protocol to prevent an incorrect maneuver. For the FVC maneuver, three cycles of slow normal breathing were performed before demonstrating forced inspiration and expiration. PEF is measured in liters/seconds.	Change from Baseline Peak Expiratory Flow at 8 weeks.
Primary	Forced Expiratory Flow from 25% to 75% of vital capacity (FEF25-75%) change	FEF25-75% is the average flow from the point at which 25 percent of the FVC has been exhaled to the point at which 75 percent of the FVC has been exhaled. The participants were asked to wear a nose clip while sitting on a chair, and the researcher gave the participants the step-by-step protocol to prevent an incorrect maneuver. For the FVC maneuver, three cycles of slow normal breathing were performed before demonstrating forced inspiration and expiration. FEF25-75% is measured in liters/seconds.	Change from Baseline Forced Expiratory Flow from 25% to 75% of vital capacity (FEF25-75%) at 8 weeks.
Primary	The ratio of forced expiratory volume in 1 second to forced vital capacity (FEV1/FVC) change	It represents the proportion of a person's vital capacity that they are able to expire in the first second of forced expiration (FEV1) to the full, forced vital capacity (FVC). The participants were asked to wear a nose clip while sitting on a chair, and the researcher gave the participants the step-by-step protocol to prevent an incorrect maneuver. For the FVC maneuver, three cycles of slow normal breathing were performed before demonstrating forced inspiration and expiration. FEV1/FVC was showed in percentage.	Change from Baseline The ratio of forced expiratory volume in 1 second to forced vital capacity at 8 weeks.
Primary	Respiratory muscle strength change	Respiratory muscle strength was assessed by measuring Maximal Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP) in cmH2O. The participants were in a sitting position using a portable handheld mouth pressure meter (i.e., MicroRPM) with a nose clip. For the MIP measurement, the participants were asked to exhale until they felt no air remaining in their lungs (starting with the functional residual capacity [FRC] point), then held the device on their mouth and inhaled forcefully for 1-2 seconds. For the MEP measurement, the participants were asked to inhale until their lungs were completely filled with air (starting with the total lung capacity [TLC] point), then they kept the device on their mouth and exhaled forcefully for 1-2 seconds	Change from Baseline respiratory muscle strength at 8 weeks.
Primary	Maximal Voluntary Ventilation (MVV) change	The participants were asked to inhale and exhale quickly and forcefully for 10 seconds. Maximal Voluntary Ventilation (MVV) were measured in liters/minutes.	Change from Baseline Maximum Voluntary Ventilation at 8 weeks.
Primary	Impact of COPD change	The impact of COPD was assessed using the mMRC and the CAT. The mMRC has a 5-point (0-4) scale based on the severity of dyspnea, whereas the CAT is a patient-completed instrument to assess and quantify the quality of life and burden of the symptoms in patients with COPD. It consists of eight questions, each of which had a semantic 6-point (0-5) differential scale, providing a total score of up to 40 points. The scores 0-10, 11-20, 21-30, and 31-40 represented mild, moderate, severe, and very severe clinical impact, respectively.	Change from Baseline Impact of COPD at 8 weeks.
Secondary	Cytokines change	The participants were asked for intravenous blood puncture 5 cc. The levels of cytokines (Tumor necrosis factor alpha;TNF-a and Interluekin-6; IL-6 were measured in pg/ml) were determined by using the multiplex inflammation from the plasma.	Change from baseline cytokines at 8 weeks.
Secondary	Malondialdehydes (MDA) change	The participants were asked for intravenous blood puncture 5 cc. Malondialdehydes (MDA) was analyzed by the lipid peroxidation (MDA) fluorometric assay kit in µmol/L.	Change from baseline Malondialdehydes at 8 weeks.
Secondary	Aerobic capacity change	Aerobic capacity was assessed using the 6-MWD, following the guidelines of the 2002 ATS. A modified settlement of the 25 m straight walking test with turning points. Participants were asked to wear comfortable clothes and shoes during the test, and their vital signs (i.e., resting heart rate and blood pressure) were evaluated before and after the test. The participants were asked to walk at a comfortable pace for 6 minutes under the supervision of a nurse and were permitted to terminate and rest during the test if they sensed heavy dyspnea.	Change from Baseline aerobic capacity at 8 weeks.