Effects of Farinelli's Breathing Exercise in COPD Patients

NCT04869033 | Completed DMC

• 1 other identifier: EX PHYSIO SPSC 2
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

COPD Patients

Keywords

Farinelli's breathing exercise; COPD; pulmonary function; respiratory muscle strength; aerobic capacity; cytokine; COPD symptoms

Outcome Measures

Primary Outcomes (12)

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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 Outcomes (3)

• Cytokines change

  Change from baseline cytokines at 8 weeks.

• Malondialdehydes (MDA) change

  Change from baseline Malondialdehydes at 8 weeks.

• Aerobic capacity change

  Change from Baseline aerobic capacity at 8 weeks.

Study Arms (2)

Farinelli's breathing group

EXPERIMENTAL

Complete Farinelli's breathing exercise 5 times per week for 8 weeks.

Other: Farinelli's Breathing Exercise

Diaphragmatic breathing group (control group)

OTHER

Complete Diaphragmatic breathing exercise 5 times per week for 8 weeks.

Other: Diaphragmatic Breathing Exercise

Interventions

Farinelli's Breathing Exercise OTHER

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.

Farinelli's breathing group

Diaphragmatic Breathing Exercise OTHER

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.

Diaphragmatic breathing group (control group)

Eligibility Criteria

• Age: 51 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Faculty of Sports Science, Chulalongkorn University

Bangkok, 10330, Thailand

Location

Related 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.

  PMID: 27373322 BACKGROUND

• 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.

  PMID: 20188719 BACKGROUND

• 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. doi: 10.1097/00008483-200201000-00002.

  PMID: 11839992 BACKGROUND

• Gosselink R. Breathing techniques in patients with chronic obstructive pulmonary disease (COPD). Chron Respir Dis. 2004;1(3):163-72. doi: 10.1191/1479972304cd020rs.

  PMID: 16281658 BACKGROUND

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

  PMID: 23076942 BACKGROUND

• 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.

  PMID: 27976662 BACKGROUND

• 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.

  PMID: 30584292 BACKGROUND

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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. The dependent variables between pre-test and post-test were analyzed by a paired t-test. Independent t-test was used to compare the variables between groups. Differences were significant at p \< .05.

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: May 3, 2021
• Study Start: January 7, 2020
• Primary Completion: August 27, 2020
• Study Completion: August 27, 2020
• Last Updated: May 3, 2021

Record last verified: 2021-04

Locations

TH (1)