NCT06827379

Acute Effects of Inspiratory Muscle Training on Peripheral Muscle Metabolism and Autonomic Response in COPD Patients

Acute Effects of Inspiratory Muscle Training With Different Loads on Peripheral Muscle Metabolism and Autonomic Response in COPD Patients: A Randomized Crossover Trial

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Federal University of Paraíba · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study will evaluate the acute effects of inspiratory muscle training (IMT) on peripheral muscle metabolism and autonomic response in patients with chronic obstructive pulmonary disease (COPD). This is a randomized, crossover study, with blinding of the evaluator and the researcher responsible for the statistical analysis. Participants will be divided into three groups at different times: TMI- strength (F), TMI to gain inspiratory muscle strength; IMT- resistance (R), IMT for improving inspiratory muscle resistance; and TMI sham. All participants randomized in the study will participate in the three groups, with a minimum interval of 48 hours between participation in each group. Randomization will determine the sequence of participation in the three groups for all participants. For statistical analysis, an intention-to-treat approach will be used, and the groups will be compared using the Student's t test for continuous variables or the chi-square test for categorical variables. A split-plot ANOVA with repeated measures will be used for primary outcomes, and analysis of covariance will be conducted to identify differences between groups using baseline scores as covariates. Effect sizes and confidence intervals will be calculated using eta squared. It is expected that IMT applied at different loads can promote effects on vascular function, peripheral muscle metabolism and the response of the autonomic nervous system in patients with COPD, which can greatly contribute to the understanding of the physiological effects of this therapy and support its prescription. as a therapeutic intervention in the rehabilitation of patients with pulmonary diseases.

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
OTHER	IMT-S (strength)	Composed of 3 sets of 1 minute of maximum, deep inspirations, with 2 minutes of rest between sets, totaling 3 minutes of IMT. The initial load will be individualized according to the MIP, with the load equivalent to 60% of the MIP.
OTHER	IMT-R (resistance)	Composed of 3 sets of 2 minutes of maximum, deep inspirations, with 2 minutes of rest between sets, totaling 6 minutes of IMT. The load will also be individualized according to the MIP, with the load equivalent to 30% of the MIP.
OTHER	Sham - IMT	Composed of 3 sets of 2 minutes of maximum, deep inspirations, with 2 minutes of rest between sets, totaling 6 minutes of IMT with a minimum load of 3cmH2O.

Timeline

• Start date: 2025-03-01
• Primary completion: 2025-12-01
• Completion: 2025-12-30
• First posted: 2025-02-14
• Last updated: 2025-05-23

Locations

1 site across 1 country: Brazil