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

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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.
• Другое 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.
• Другое 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.

Первичные конечные точки

• Peripheral vascular function and muscle metabolism [Срок оценки: Up to four weeks]
• Heart rate and R-R interval recordings [Срок оценки: Up to four weeks]

Вторичные конечные точки (7)

• Subjective perception of effort [Срок оценки: Up to four weeks]
• Lung function [Срок оценки: Up to four weeks]
• Respiratory muscle function [Срок оценки: Up to four weeks]
• Thickness and thickening fraction and diaphragmatic mobility [Срок оценки: Up to four weeks]
• Echointensity and thickness of the quadriceps femoris [Срок оценки: Up to four weeks]
• Feeling of dyspnea [Срок оценки: Up to four weeks]
• Functional capacity [Срок оценки: Up to four weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Бразилия · 1 центр

• Universidade Federal da Paraíba — João Pessoa

Публикации

• Borges NMDS, Lima DT, Morais ABA, Tenorio LNFC, Vieira ST, Carneiro HMLO, Freitas AL, Silva DFS, Silva ED, Paiva MAOS, Silva JVBD, Guedes KP, Gama TO, Fernandes ATDNSF, Azevedo IG, Morais PSA, Pereira DAG, Pedrosa R, Lima JHM, Franca EET. Acute Effect of Inspiratory Muscle Training on Peripheral Tissue Oxygenation Behavior in Individuals With COPD: A Randomized Crossover Study. Physiother Res Int. PMID 41738531

Идентификаторы

NCT: NCT06827379 · 6.669.065

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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