Clinical trial

Effects of Respiratory Muscle Training in Post-bariatric Surgery Patients

Recruiting now · Not applicable · 1 countries · Registry ID NCT07289958

Recruiting nowNot applicableInterventional

What this study is 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 60 Years
SexAll
Healthy volunteersNot accepted
ConditionBariatric Surgery

Full registry 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

Treatments and study arms

Institutionalized therapeutic exercise

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

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

Other

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

Primary outcomes

Maximum inspiratory pressure (MIP)Before and after intervention (12 weeks)

Maximum inspiratory pressure (MIP) is the maximum level of pressure applied to the lungs during inhalation. In normal breathing, this value reflects a negative pressure in centimeters of water (cm H₂O).

Sleep ApneaBefore and after intervention (12 weeks)

Sleep apnea is a potentially serious sleep disorder in which breathing stops and starts repeatedly. They are measured with sleep tests that measure heart rate, oxygen levels, airflow, and breathing patterns. The Apnea-Hypopnea Index (AHI) is a measure of the number of times a person stops breathing (apnea) or has shallow breathing (hypopnea) per hour of sleep. A higher AHI indicates greater severity, with typical ranges classifying the condition as mild (5-15 events/hour), moderate (16-30 events/hour), or severe (more than 30 events/hour).

1-minute Sit-to-Stand testBefore and after intervention (12 weeks)

Number of sit-to- stand repetitions done in 1 minute (STS-1m). A 46-cm high chair will be used.

Walking distanceBefore and after intervention (12 weeks)

The six-minute walking test (6MWT) will be used to determine walking distance, in meters (m), covered during six minutes. A 20-meter indoor corridor will be used and patients will be encouraged to walk as much as possible during that time.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Carlos Andrade Marín Hospital🌐 Quito, Pichincha, Ecuador
Jessica Pinzón, Dr.Contact
Saul Caicedo, MscContact
Saúl Caicedo, MscPrincipal Investigator