Clinical trial NCT06827379: Acute Effects of Inspiratory Muscle Training on Peripheral Muscle Metabolism and Autonomic Response in COPD Patients
Official title: Acute Effects of Inspiratory Muscle Training With Different Loads on Peripheral Muscle Metabolism and Autonomic Response in COPD Patients: A Randomized Crossover Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD
Exercise
Performance
Lung diseases.
Lead sponsor: Federal University of Paraíba
Sponsor class: OTHER
First posted: 2025-02-14
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a crossover, randomized study, blinded to the evaluator and the researcher responsible for the statistical analysis. The study will evaluate the acute effects of IMT on peripheral muscle metabolism and the autonomic response of patients with COPD and its participants will participate in three groups at different times: IMT-S (strength): IMT to gain inspiratory muscle strength; TMI-R (resistance): TMI to improve inspiratory muscle resistance and Sham - Sham of TMI. All participants randomized to the study will participate in the three groups with a minimum interval of 48 hours between participation in each of the groups. Randomization will be performed to find out the sequence of participation in the three groups for all participants. For statistical analysis, intention-to-treat analysis will be employed and groups will be compared using Students t-test, for continuous variables, or chi-square, for categorical variables.

ANOVA split-plot, repeated measures for prim.
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Peripheral vascular function and muscle metabolism
timeFrame: Up to four weeks
measure: Heart rate and R-R interval recordings
timeFrame: Up to four weeks
Secondary outcomes:
measure: Subjective perception of effort
timeFrame: Up to four weeks
measure: Lung function
timeFrame: Up to four weeks
measure: Respiratory muscle function
timeFrame: Up to four weeks
measure: Thickness and thickening fraction and diaphragmatic mobility
timeFrame: Up to four weeks
measure: Echointensity and thickness of the quadriceps femoris
timeFrame: Up to four weeks
measure: Feeling of dyspnea
timeFrame: Up to four weeks
measure: Functional capacity
timeFrame: Up to four weeks
Other outcomes:
Locations:
city: João Pessoa
country: Brazil
facility: Universidade Federal da Paraíba
state: Paraíba
Study officials:
References: