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

NCT06827379 | Enrolling By Invitation

• 1 other identifier: 6.669.065
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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)

Keywords

COPD; Exercise; Performance; Lung diseases.

Outcome Measures

Primary Outcomes (2)

• Peripheral vascular function and muscle metabolism

  Evaluated using Near Infrared Spectroscopy (NIRS). Tissue perfusion measurement will be performed using an arterial occlusion maneuver. After three minutes of rest to stabilize the initial measurements; \[tissue oxygen saturation (StO2) measured in percentage (%), oxyhemoglobin (HbO2) and deoxyhemoglobin (HHb) measured in mmHg\], the cuff will be inflated above 250 mmHg up to 280 mmHg , so that the blood flow is completely interrupted, being maintained for a period of five minutes, until the stabilization of the measurements. The variables obtained during the arterial occlusion maneuver will be: StO2 recovery time after occlusion, HHb variation during occlusion and StO2 variation during occlusion. The variables obtained during the exercise will be: variation of HHb and StO2, time to reach the lowest StO2, rate of deoxygenation and reoxygenation and walking economy in relation to HHb and StO2.

  Up to four weeks

• Heart rate and R-R interval recordings

  Patients will be evaluated in the laboratory at 22 degrees Celsius (°C) with relative humidity between 50-60%. They should avoid stimulants, alcohol and exercise the day before the test and refrain from smoking or using bronchodilators for 6 hours before the test. An electrocardiogram will be recorded via Holter (CARDIOS™, Brazil) using a bipolar DII electrode, with three electrodes placed on the chest after asepsis and trichotomy. Holter software will provide time series data of heart intervals, analyzing heart rate variability (HRV) in both the time and frequency domains. In the time domain, indicators of sympathetic and parasympathetic activity will be calculated. In the frequency domain, the low, high and very low frequency bands will be evaluated, with the ratio between low frequency and high frequency, representing sympathovagal balance.

  Up to four weeks

Secondary Outcomes (7)

• Subjective perception of effort

  Up to four weeks

• Lung function

  Up to four weeks

• Respiratory muscle function

  Up to four weeks

• Thickness and thickening fraction and diaphragmatic mobility

  Up to four weeks

• Echointensity and thickness of the quadriceps femoris

  Up to four weeks

Study Arms (3)

IMT-S (strength)

EXPERIMENTAL

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.

Other: IMT-S (strength)

IMT-R (resistance)

EXPERIMENTAL

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.

Other: IMT-R (resistance)

Sham

SHAM COMPARATOR

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.

Other: Sham - IMT

Interventions

IMT-S (strength) 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-S (strength)

IMT-R (resistance) 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.

IMT-R (resistance)

Sham - IMT 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.

Sham

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Paraíba: lead

Study Sites (1)

Universidade Federal da Paraíba

João Pessoa, Paraíba, 58051-900, Brazil

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity; Lung Diseases

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Blinding of the evaluator and the researcher responsible for statistical analysis.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 30, 2025
• First Posted: February 14, 2025
• Study Start: March 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 30, 2025
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)