Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07415746

Functional Assessment and Pulmonary Rehabilitation: Challenges and Perspectives for Comprehensive Care

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Teaching and Assistance Unit in Physiotherapy and Occupational Therapy

Belém, Pará, 66093605, Brazil

Location contact

Gleidiane L. S. Santos

CONTACT

[email protected]

55+ (91) 991023889

About this study

This study aims to evaluate diaphragmatic muscle function and mobility through ultrasonography in individuals diagnosed with Chronic Obstructive Pulmonary Disease (COPD) undergoing a pulmonary rehabilitation program combined with inspiratory muscle training (IMT). The research will investigate the relationship between diaphragmatic behavior, clinical severity, and the repercussions on respiratory capacity.

Upon meeting the inclusion criteria, participants will undergo an initial clinical and sociodemographic assessment, including medical history, spirometry, manovacuometry, and the 6-Minute Walk Test (6MWT). Symptom impact and dyspnea will be measured using the COPD Assessment Test (CAT) and the mMRC scale. Participants will then be allocated into two groups:

IMT Group (IMTG): Participants will perform IMT using the PowerBreathe Classic (3 sets of 10 reps; load increasing from 50% to 60% of MIP), followed by resistance training (60-70% of 1RM) and aerobic training (20 minutes on a stationary bike at 60-80% intensity based on the Karvonen Formula and Borg Scale 4-6).

Control Group (CG): Participants will undergo the exact same resistance and aerobic training protocols as the IMTG. However, they will perform a Sham IMT using the device at its minimum load setting (3 sets of 10 reps) to maintain the same training volume and procedural consistency without the threshold training effect.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Pulmonary rehabilitation combined with inspiratory muscle training

Device

Rehabilitation 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

Device

Pulmonary 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.

Primary outcomes

  1. Diaphragmatic Excursion (DE)

    Time frame: Baseline and after 7 weeks.

    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).

Secondary outcomes

  1. Diaphragmatic Thickness (Tdi)

    Time frame: Baseline and after 7 weeks.

    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).

  2. Diaphragmatic Thickening Fraction (DTF)

    Time frame: Baseline and after 7 weeks.

    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).

  3. Lung Function Parameters (Spirometry)

    Time frame: Baseline and after 7 weeks.

    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).

  4. Respiratory Muscle Strength (MIP and MEP)

    Time frame: Baseline and after 7 weeks.

    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).

  5. COPD Assessment Test (CAT) Score

    Time frame: Baseline and after 7 weeks

    The CAT is a validated questionnaire used to assess the impact of Chronic Obstructive Pulmonary Disease (COPD) on health status. It consists of 8 items, each scored from 0 to 5. Total scores range from 0 to 40, where higher scores indicate a greater impact of the disease on the patient's life.

  6. Medical Research Council (MRC) Dyspnea Scale

    Time frame: Baseline and after 7 weeks of intervention.

    A scale composed of 5 items ranging from 0 to 4 points, used to grade the functional limitation caused by dyspnea in activities of daily living. As recommended by the guidelines of the Brazilian Society of Pulmonology and Phthisiology (SBPT), the scale assesses the patient's subjective perception, where higher scores indicate greater symptom severity and a worse prognosis in COPD.

  7. Functional Capacity (6-Minute Walk Test - 6MWT)

    Time frame: Baseline and after 7 weeks.

    The test will be applied in a standardized manner and according to the guidelines established by the American Thoracic Society (ATS), recording systemic blood pressure (BP, in mmHg), heart rate (HR, in bpm), respiratory rate (RR, in bpm), peripheral oxygen saturation (SpO2, in %), and dyspnea level at the beginning and end of the test, using the modified Borg scale (APPENDIX C). The test will be performed in a corridor at least 30 meters long, with a flat, non-slip surface. At the turnaround points, there will be cones signaling for the volunteer to complete the laps within the determined time. At the end, the distance covered in meters will be calculated (ATS, 2002; BORGES; CARVALHO, 2006).

Study contacts

Contact information is provided by the study sponsor or research team.

Gleidiane L. S. Santos

CONTACT

[email protected]

55+ (91) 991023889

Sponsors and collaborators

Lead sponsor

Universidade do Estado do Pará

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 17, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.