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

NCT ID: NCT06827379

Last Updated: 2025-05-23

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2025-12-30

Brief 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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

IMT-S (strength)

Will be individualized according to the MIP achieved in the initial assessment of each patient's inspiratory muscle strength, with the load being equivalent to 60% of the MIP in cmH2O.

Group Type: EXPERIMENTAL

IMT-S (strength)

Intervention Type: OTHER

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.

IMT-R (resistance)

Three sets of two minutes of maximum, deep inspirations followed by two minutes of rest between them, totaling six minutes of IMT. The initial load of the equipment for the IMT-R group will also be individualized, equivalent to 30% of the MIP in cmH2O.

Group Type: EXPERIMENTAL

IMT-R (resistance)

Intervention Type: OTHER

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.

Sham

Three sets of two minutes of maximum, deep inspirations followed by two minutes of rest between them, totaling six minutes of IMT with a minimum load of 3cmH2O.

Group Type: SHAM_COMPARATOR

Sham - IMT

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients with COPD according to the Global Initiative for COPD (GOLD, 2023);
• Aged 40 years or older and under 75 years;
• Providing both oral and written informed consent.

Exclusion Criteria

• Inability to perform the IMT protocol and/or functional tests;
• Presence of psychiatric disorders or cognitive impairments, progressive neurological disorders, cancer, or chronic pain;
• Cognitive impairment or inability to understand commands.
• Patients who have experienced any health issue or had a COPD exacerbation in the previous month will also be excluded to ensure that the patient's symptoms are stable.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Paraíba

OTHER

Sponsor Role: lead

Responsible Party

Eduardo Eriko Tenório de França

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidade Federal da Paraíba

João Pessoa, Paraíba, Brazil

Countries

Brazil

Other Identifiers

6.669.065

Identifier Type: -

Identifier Source: org_study_id