Clinical trial NCT04869033: Effects of Farinelli's Breathing Exercise in COPD Patients
Official title: Effects of Farinelli's Breathing Exercise on Cardiorespiratory Fitness and Symptoms in COPD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD Patients
Keywords: Farinelli's breathing exercise
COPD
pulmonary function
respiratory muscle strength
aerobic capacity
cytokine
COPD symptoms
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2021-05-03
Enrollment: 16
Sex: ALL
Minimum age (years): 51
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: BASIC_SCIENCE

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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Force Vital Capacity (FVC) change
timeFrame: Change from Baseline Force Vital Capacity at 8 weeks.
measure: Forced expiratory volume in 1 second (FEV1) change
timeFrame: Change from Baseline Forced expiratory volume in 1 second at 8 weeks.
measure: Tidal Volume (TV) change
timeFrame: Change from Baseline Tidal Volume at 8 weeks.
measure: Inspiratory Reserve Volume (IRV) change
timeFrame: Change from Baseline Inspiratory Reserve Volume at 8 weeks.
measure: Expiratory Reserve Volume (ERV) change
timeFrame: Change from Baseline Expiratory Reserve Volume at 8 weeks.
measure: Inspiratory capacity (IC) change
timeFrame: Change from Baseline Inspiratory Capacity at 8 weeks.
measure: Peak Expiratory Flow (PEF) change
timeFrame: Change from Baseline Peak Expiratory Flow at 8 weeks.
measure: Forced Expiratory Flow from 25% to 75% of vital capacity (FEF25-75%) change
timeFrame: Change from Baseline Forced Expiratory Flow from 25% to 75% of vital capacity (FEF25-75%) at 8 weeks.
measure: The ratio of forced expiratory volume in 1 second to forced vital capacity (FEV1/FVC) change
timeFrame: Change from Baseline The ratio of forced expiratory volume in 1 second to forced vital capacity at 8 weeks.
measure: Respiratory muscle strength change
timeFrame: Change from Baseline respiratory muscle strength at 8 weeks.
measure: Maximal Voluntary Ventilation (MVV) change
timeFrame: Change from Baseline Maximum Voluntary Ventilation at 8 weeks.
measure: Impact of COPD change
timeFrame: Change from Baseline Impact of COPD at 8 weeks.
Secondary outcomes:
measure: Cytokines change
timeFrame: Change from baseline cytokines at 8 weeks.
measure: Malondialdehydes (MDA) change
timeFrame: Change from baseline Malondialdehydes at 8 weeks.
measure: Aerobic capacity change
timeFrame: Change from Baseline aerobic capacity at 8 weeks.
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Sports Science, Chulalongkorn University
Study officials:
References:
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