Effects of Respiratory Muscle Training in Post-bariatric Surgery Patients

University Ramon Llull

Status: Not yet enrolling

Conditions: Bariatric Surgery

Treatments: Other: simulated inspiratory muscle; Behavioral: Institutionalized therapeutic exercise; Behavioral: Inspiratory muscle training

Study type: Interventional

Funder types: Other

Identifiers

NCT07289958

2025-IMTObes

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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52 participants in 4 patient groups

Control Group

Sham Comparator group

Description:

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

Treatment:

Other: simulated inspiratory muscle

Inspiratory muscle training

Experimental group

Description:

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.

Treatment:

Behavioral: Inspiratory muscle training

Institutionalized therapeutic exercise + simulated inspiratory muscle training

Experimental group

Description:

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.

Treatment:

Behavioral: Inspiratory muscle training

Other: simulated inspiratory muscle

Institutionalized therapeutic exercise + inspiratory muscle training

Experimental group

Description:

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.

Treatment:

Behavioral: Inspiratory muscle training

Behavioral: Institutionalized therapeutic exercise