NCT07415746

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Universidade do Estado do Pará · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Pulmonary Disease, Chronic Obstructive

Interventions

Type	Name	Description
DEVICE	Pulmonary rehabilitation combined with inspiratory muscle training	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%).
DEVICE	Pulmonary rehabilitation with placebo inspiratory muscle training	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.

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2026-02-17
• Last updated: 2026-02-17

Locations

1 site across 1 country: Brazil