COPD PatientsNCT04869033

Effects of Farinelli's Breathing Exercise in COPD Patients

A study testing Farinelli's Breathing Exercise and Diaphragmatic Breathing Exercise in people with COPD Patients, run by Chulalongkorn University at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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). Read more about this study

Who is it for?: Ages 51 to 80 years
Conditions the study is for: COPD Patients
What is being tested?: Farinelli's Breathing Exercise and Diaphragmatic Breathing Exercise
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteThailand
Study dates: 7 Jan 2020to 27 Aug 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 51 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Thailand1 site

Faculty of Sports Science, Chulalongkorn University
Bangkok, 10330

Other trials in Thailand

About this study

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

Read the detailed 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.

Conditions: COPD Patients
Being tested: Farinelli's Breathing Exercise, Diaphragmatic Breathing Exercise
Keywords: Farinelli's breathing exercise, COPD, pulmonary function, respiratory muscle strength, aerobic capacity, cytokine, COPD symptoms
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Farinelli's Breathing ExerciseOther
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 ExerciseOther
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.

Study groups in NCT04869033
Study group	Role	What they receive
Farinelli's breathing group	Experimental	Complete Farinelli's breathing exercise 5 times per week for 8 weeks. Receives: Other: Farinelli's Breathing Exercise
Diaphragmatic breathing group (control group)	Other	Complete Diaphragmatic breathing exercise 5 times per week for 8 weeks. Receives: Other: Diaphragmatic Breathing Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Change from Baseline Impact of COPD at 8 weeks.

Secondary outcomes (3)

Cytokines change
The participants were asked for intravenous blood puncture 5 cc. The levels of cytokines (Tumor necrosis factor alpha;TNF-α and Interluekin-6; IL-6 were measured in pg/ml) were determined by using the multiplex inflammation from the plasma.
Measured: Change from baseline cytokines at 8 weeks.
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.
Measured: Change from baseline Malondialdehydes at 8 weeks.
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.
Measured: Change from Baseline aerobic capacity at 8 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Jan 202027 Aug 2020

First posted3 May 2021
Study start7 Jan 2020
Primary completion27 Aug 2020
Study completion27 Aug 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for COPD PatientsStudies of the same condition, open and under way.
More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Model 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. 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.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04869033
Sponsor's protocol ID: EX PHYSIO SPSC 2
Status last verified: Apr 2021
First submitted: 1 Apr 2021
Last updated: 3 May 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 27373322
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.
PubMed 20188719
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.
PubMed 11839992
Gosselink R. Breathing techniques in patients with chronic obstructive pulmonary disease (COPD). Chron Respir Dis. 2004;1(3):163-72. doi: 10.1191/1479972304cd020rs.
PubMed 16281658
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.
PubMed 23076942
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.
PubMed 27976662
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.
PubMed 30584292

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Farinelli's Breathing Exercise on Cardiorespiratory Fitness and Symptoms in COPD Patients
ClinicalTrials.gov ID: NCT04869033
Acronym / sponsor ID: EX PHYSIO SPSC 2
Conditions: COPD Patients
Keywords: Farinelli's breathing exercise, COPD, pulmonary function, respiratory muscle strength, aerobic capacity, cytokine, COPD symptoms
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Chulalongkorn UniversityUniversity, hospital or other
Study start: 7 Jan 2020 (actual)
Primary completion: 27 Aug 2020 (actual)
Study completion: 27 Aug 2020 (actual)
First posted: 3 May 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model 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. 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.

Arm	Type	Receives
Farinelli's breathing group	Experimental	Other: Farinelli's Breathing ExerciseComplete Farinelli's breathing exercise 5 times per week for 8 weeks.
Diaphragmatic breathing group (control group)	Other	Other: Diaphragmatic Breathing ExerciseComplete Diaphragmatic breathing exercise 5 times per week for 8 weeks.

Who may qualify

Ages: 51 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Farinelli's Breathing Exerciseafter 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.	Other	Farinelli's breathing group
Diaphragmatic Breathing Exerciseafter 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.	Other	Diaphragmatic breathing group (control group)

Primary outcome

Force Vital Capacity (FVC) change
Time frame: Change from Baseline Force Vital Capacity at 8 weeks.
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.
Forced expiratory volume in 1 second (FEV1) change
Time frame: Change from Baseline Forced expiratory volume in 1 second at 8 weeks.
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.
Tidal Volume (TV) change
Time frame: Change from Baseline Tidal Volume at 8 weeks.
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.
Inspiratory Reserve Volume (IRV) change
Time frame: Change from Baseline Inspiratory Reserve Volume at 8 weeks.
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.
Expiratory Reserve Volume (ERV) change
Time frame: Change from Baseline Expiratory Reserve Volume at 8 weeks.
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.
Inspiratory capacity (IC) change
Time frame: Change from Baseline Inspiratory Capacity at 8 weeks.
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.
Peak Expiratory Flow (PEF) change
Time frame: Change from Baseline Peak Expiratory Flow at 8 weeks.
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.
Forced Expiratory Flow from 25% to 75% of vital capacity (FEF25-75%) change
Time frame: Change from Baseline Forced Expiratory Flow from 25% to 75% of vital capacity (FEF25-75%) at 8 weeks.
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.
The ratio of forced expiratory volume in 1 second to forced vital capacity (FEV1/FVC) change
Time frame: Change from Baseline The ratio of forced expiratory volume in 1 second to forced vital capacity at 8 weeks.
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.
Respiratory muscle strength change
Time frame: Change from Baseline respiratory muscle strength at 8 weeks.
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
Maximal Voluntary Ventilation (MVV) change
Time frame: Change from Baseline Maximum Voluntary Ventilation at 8 weeks.
The participants were asked to inhale and exhale quickly and forcefully for 10 seconds. Maximal Voluntary Ventilation (MVV) were measured in liters/minutes.
Impact of COPD change
Time frame: Change from Baseline Impact of COPD at 8 weeks.
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.

3 secondary outcomes

Cytokines change
Time frame: Change from baseline cytokines at 8 weeks.
Malondialdehydes (MDA) change
Time frame: Change from baseline Malondialdehydes at 8 weeks.
Aerobic capacity change
Time frame: Change from Baseline aerobic capacity at 8 weeks.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
Background: PubMed 27373322Barnes 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.
Background: PubMed 20188719Beavers 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.
Background: PubMed 11839992Cahalin 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.
Background: PubMed 16281658Gosselink R. Breathing techniques in patients with chronic obstructive pulmonary disease (COPD). Chron Respir Dis. 2004;1(3):163-72. doi: 10.1191/1479972304cd020rs.
Background: PubMed 23076942Holland 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.
Background: PubMed 27976662Ksinopoulou 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.
Background: PubMed 30584292Leelarungrayub 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.

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COPD Exacerbation, Oxygen Toxicity
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Farinelli's Breathing Exercise and Diaphragmatic Breathing Exercise in people with COPD Patients, run by Chulalongkorn University at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Force Vital Capacity (FVC) change (time frame: Change from Baseline Force Vital Capacity at 8 weeks.). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04869033, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2021.