Functional Assessment and Pulmonary Rehabilitation: Challenges and Perspectives for Comprehensive Care
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorUniversidade do Estado do Pará
About this trial
Individuals with Chronic Obstructive Pulmonary Disease (COPD) present with respiratory muscle dysfunction, characterized by reduced diaphragmatic contractility and mobility due to pulmonary hyperinflation, oxidative stress, and systemic inflammation. Effective assessment of diaphragmatic function is crucial for monitoring progress in pulmonary rehabilitation programs. This study aims to evaluate diaphragmatic function and mobility in COPD patients undergoing pulmonary rehabilitation with inspiratory muscle training, using ultrasound, and to identify associations between diaphragmatic dysfunction and clinical symptoms such as dyspnea and fatigue. A randomized clinical trial will be conducted to investigate the impact of rehabilitation on diaphragmatic function, correlating it with pulmonary function and physical performance.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 40 years or older.
Both sexes are eligible (men and women).
Clinically diagnosed COPD, clinically stable, classified in Stages I, II, III or IV of GOLD (Global Initiative for Chronic Obstructive Lung Disease).
Ability to understand and provide the signed Informed Consent Form to participate in the study.
Disqualifiers
Physical limitations and/or cognitive impairment that prevent the execution of the study protocol.
Currently engaged in physical therapy treatment and/or physical activity that may interfere with the study results.
Presence of severe, uncontrolled, or disabling comorbidities.
Trial design
Design model
Parallel
Treatments tested in this trial
Pulmonary rehabilitation combined with inspiratory muscle training
DeviceRehabilitation will begin with diaphragmatic breathing and Inspiratory Muscle Training (IMT) with the Powerbreathe Classic device (3 sets of 10 repetitions, 1 min rest). The initial load will be 50% of PImáx, progressing 10% every 10 sessions until reaching 60%, with monitoring for fatigue and dyspnea. Resistance Training (RT) will utilize lat pulldown, bench press, and leg press on the weight training station. The load is based on the 1RM test, starting at 60% and progressing to 70% after 10 sessions. Aerobic Training (AT) will take place on a stationary bike for 20 min (5 min warm-up and 15 min workout). To calculate the Training Heart Rate (THR), the Karvonen formula will be used: THR = (HRmax - HRrest) x % target intensity + HRrest, followed by the calculation of the Maximum Heart Rate (HRmax) using the Tanaka formula: HRmax = 208 - (0.7 x age). The target intensity will be set between moderate (60% - 70%) and high (70% - 80%).
Pulmonary rehabilitation with placebo inspiratory muscle training
DevicePulmonary rehabilitation will consist of resistance and aerobic training protocols with the same specifications as the TMI Group. The placebo TMI will be performed on the Powerbreathe device with minimal load, consisting of 3 sets of 10 repetitions interspersed with 1 minute of rest.
Treatment groups
46 Participants
are divided into 2 treatment groupsGroup A: TMI Group (GT)Active comparator 1 intervention
Group B: Control Group (CG)Sham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Diaphragmatic Excursion (DE)
Diaphragmatic excursion will be assessed by visualizing the right hemidiaphragm via an anterior subcostal approach between the midclavicular and anterior axillary lines, using a convex transducer in M-mode, with results expressed in millimeters (mm).
Time frame
Baseline and after 7 weeks.Secondary outcomes
1
Diaphragmatic Thickness (Tdi)
Diaphragm thickness will be assessed using a linear B-mode transducer, positioned between the eighth and ninth intercostal spaces in the anterior mid-axillary line, with the result expressed in centimeters (cm).
Time frame
Baseline and after 7 weeks.2
Diaphragmatic Thickening Fraction (DTF)
The DTF is calculated as follows: \[(thickness at end-inspiration - thickness at end-expiration) / thickness at end-expiration\] x 100. It is an indicator of diaphragmatic contractile activity (VIEIRA et al., 2020).
Time frame
Baseline and after 7 weeks.3
Lung Function Parameters (Spirometry)
Pulmonary function will be assessed using the MIR SPIRODOC spirometer with WinspiroPRO software. At least three maneuvers will be performed to obtain the best curve, following international guidelines. The following parameters will be evaluated: Forced Vital Capacity (FVC), Forced Expiratory Volume in the first second (FEV1), FEV1/FVC ratio (Tiffeneau index), Forced Expiratory Flow between 25% and 75% of FVC (FEF25-75%), and Forced Expiratory Time (FET).
Time frame
Baseline and after 7 weeks.4
Respiratory Muscle Strength (MIP and MEP)
Respiratory muscle strength will be assessed using the MVD300 digital manometer (Globalmed), with results expressed in cmH2O. The protocol includes measuring Maximum Inspiratory Pressure (MIP) and Maximum Expiratory Pressure (MEP). Participants will perform maneuvers until they obtain three acceptable measurements, with a variation of less than 10% between them. The highest value will be recorded for analysis. Predicted values will be calculated based on the equations proposed by Neder et al. (1999).
Time frame
Baseline and after 7 weeks.Sponsors and contacts
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Source ClinicalTrials.gov
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