Effects of Respiratory Muscle Training in Post-bariatric Surgery Patients

Официальное название

Effects of Respiratory Muscle Training on Cardiovascular, Respiratory, Metabolic and Physical Exercise Capacity Parameters Related to Obesity in Post-bariatric Surgery Patients

Обзор

Obesity is a health condition caused by excessive accumulation of body fat. This condition is linked to the development of chronic diseases and also places increased stress on the respiratory system, leading to respiratory disorders, exacerbation of preexisting respiratory conditions, and a decline in physical capacity and exercise tolerance. Respiratory muscle training has been shown to have beneficial effects on respiratory function in these patients, although the effects this strategy has on other metabolic and physiological aspects related to exercise and obesity that are affected remain unclear.

Подробное описание

The present study describes a randomized clinical trial developed for 12 weeks with the purpose of the study is to determine that respiratory muscle training produces positive effects on cardiovascular, respiratory, metabolic and physical exercise capacity parameters related to obesity in post-bariatric surgery patients.

The study divides the subjects into two research arms in a relationship of 2 groups per branch: A) Intervention group: institutionalized therapeutic exercise + inspiratory muscle training device versus control group: institutionalized therapeutic exercise + sham device B) Intervention group: inspiratory muscle training device versus control group: sham device, this to determine how the inspiratory muscle training impacts in combination with physical exercise or in isolation versus physical exercise or usual care.

The evaluation criteria are maximum inspiratory pressure, sleep apnea index, sleep quality, resting heart rate, blood pressure, functional capacity, glycosated hemoglobin, lipid profile, body composition and Health-Related Quality of Life; Assessments will be conducted before and after the 12-week program.

Вмешательства

• Поведенческое Institutionalized therapeutic exercise
  Physical exercise program for cardiometabolic rehabilitation (institutionalized) with aerobic training starting with intensities of 50% to 54% of Heart Rate Reserve from week 1 to 4, increasing from 54% to 60% from week 5 to 8 and from 60% to 65% from week 9 to 12, with volumes of 10 minutes the first week and 20 minutes from week 2 to 12, neuromuscular training with intensities of 40% to 70% of 1RM estimated by OMNI RES scale with volumes of 10 to 15 repetitions 3 to 4 sets, 3 times per week.
• Поведенческое Inspiratory muscle training
  Inspiratory muscle training using a pressure threshold system exerciser with an initial intensity of 30% of maximum inspiratory pressure, increasing the pressure by 10% every 2 weeks until reaching 60% with a volume of 3 sets of 10 repetitions, 5 times per week for 12 weeks.
• Другое simulated inspiratory muscle
  Inspiratory muscle training with sham device, 5 times a week for 12 weeks.

Первичные конечные точки

• Maximum inspiratory pressure (MIP) [Срок оценки: Before and after intervention (12 weeks)]
• Sleep Apnea [Срок оценки: Before and after intervention (12 weeks)]
• 1-minute Sit-to-Stand test [Срок оценки: Before and after intervention (12 weeks)]
• Walking distance [Срок оценки: Before and after intervention (12 weeks)]

Вторичные конечные точки (12)

• Sleep quality [Срок оценки: Before and after intervention (12 weeks)]
• Resting heart rate [Срок оценки: Before and after intervention (12 weeks)]
• Blood pressure [Срок оценки: Before and after intervention (12 weeks)]
• Glycosylated hemoglobin [Срок оценки: Before and after intervention (12 weeks)]
• Lipid Profile [Срок оценки: Before and after intervention (12 weeks)]
• Body Weight [Срок оценки: Before and after the intervention (12 weeks)]
• Body fat percentage [Срок оценки: Before and after the intervention (12 weeks).]
• muscle mass [Срок оценки: Before and after the intervention (12 weeks)]
• Total body water [Срок оценки: Before and after intervention (12 weeks)]
• Health-related quality of life [Срок оценки: Before and after intervention (12 weeks)]
• Anxiety and depression [Срок оценки: Before and after intervention (12 weeks)]
• Risk of developing obstructive sleep apnea [Срок оценки: Before and after intervention (12 weeks)]

Критерии участия

Критерии включения

• Patients diagnosed with obesity within 1 month of bariatric surgery
• Both sexes
• Ages 18 to 60

Критерии исключения

• Patients with respiratory conditions that contraindicate physical exercise
• Patients with diagnosed heart disease
• Patients with psychiatric conditions
• Patients with osteoarticular conditions that make physical exercise difficult

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Ecuador · 1 центр

• Carlos Andrade Marín Hospital — Quito

Идентификаторы

NCT: NCT07289958 · 2025-IMTObes

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗