NCT07289958

Effects of Respiratory Muscle Training in Post-bariatric Surgery Patients

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: University Ramon Llull · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Bariatric Surgery

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	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.
OTHER	simulated inspiratory muscle	Inspiratory muscle training with sham device, 5 times a week for 12 weeks.

Timeline

• Start date: 2026-01-05
• Primary completion: 2027-06-30
• Completion: 2027-06-30
• First posted: 2025-12-17
• Last updated: 2026-02-18

Locations

1 site across 1 country: Ecuador