Effects of Respiratory Muscle Training in Post-bariatric Surgery Patients

NCT ID: NCT07289958

Last Updated: 2025-12-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-05
• Study Completion Date: 2027-06-30

Brief 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

Keywords

Bariatric Surgery; Inspiratory muscle training; Therapeutic exercise

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Control Group

The control group will perform inspiratory muscle training with a simulated device 5 times a week for 12 weeks and usual care.

Group Type: SHAM_COMPARATOR

simulated inspiratory muscle

Intervention Type: OTHER

Inspiratory muscle training with sham device, 5 times a week for 12 weeks.

Inspiratory muscle training

Inspiratory muscle training with intensities of 30% to 60% of maximum inspiratory performing 30 repetitions 5 times a week for 12 weeks and usual care.

Group Type: EXPERIMENTAL

Inspiratory muscle training

Intervention Type: BEHAVIORAL

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.

Institutionalized therapeutic exercise + simulated inspiratory muscle training

Aerobic training with intensities of 50 to 65% of the Reserve Heart Rate, neuromuscular training with intensities of 40 to 70% of 1RM and Inspiratory muscle training with simulated inspiratory muscle training, 5 times a week for 12 weeks.

Group Type: EXPERIMENTAL

Inspiratory muscle training

Intervention Type: BEHAVIORAL

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.

simulated inspiratory muscle

Intervention Type: OTHER

Inspiratory muscle training with sham device, 5 times a week for 12 weeks.

Institutionalized therapeutic exercise + inspiratory muscle training

Aerobic training with intensities of 50 to 65% of the Reserve Heart Rate, neuromuscular training with intensities of 40 to 70% of 1RM and Inspiratory muscle training with intensities of 30% to 60% of maximum inspiratory pressure performing 30 repetitions, 5 times a week for 12 weeks.

Group Type: EXPERIMENTAL

Institutionalized therapeutic exercise

Intervention Type: BEHAVIORAL

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.

Inspiratory muscle training

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

simulated inspiratory muscle

Inspiratory muscle training with sham device, 5 times a week for 12 weeks.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Ramon Llull

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jordi Vilaro, Phd

Role: STUDY_CHAIR

University Ramon Llull

Locations

Carlos Andrade Marín Hospital

Quito, Pichincha, Ecuador

Countries

Ecuador

Central Contacts

Jordi Vilaro, Phd

Role: CONTACT

Phone: +34 666580946

Email: jordivc@blanquerna.url.edu

Saúl Caicedo, Msc

Role: CONTACT

Phone: +593980290110

Email: saulalejandroct@blanquerna.url.edu

Facility Contacts

Jessica Pinzón, Dr.

Role: primary

Saul Caicedo, Msc

Role: backup

Other Identifiers

2025-IMTObes

Identifier Type: -

Identifier Source: org_study_id