Respiratory muscle training for people after bariatric surgery
Effects of Respiratory Muscle Training on Cardiovascular, Respiratory, Metabolic and Physical Exercise Capacity Parameters Related to Obesity in Post-bariatric Surgery Patients
This study will test whether using an inspiratory muscle training device, alone or together with supervised therapeutic exercise, helps people who recently had bariatric surgery breathe better, sleep better, and improve exercise and metabolic measures.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | University Ramon Llull Academic / other |
| Locations | 1 site (Quito, Pichincha) |
| Trial ID | NCT07289958 on ClinicalTrials.gov |
What this trial studies
This is a 12-week randomized clinical trial in post-bariatric surgery patients that compares inspiratory muscle training (IMT) with a sham device, both alone and combined with institutionalized therapeutic exercise. Participants are randomized into branches comparing exercise+IMT versus exercise+sham, and IMT alone versus sham, to isolate the device's effects and its interaction with supervised exercise. Outcomes measured before and after the program include maximum inspiratory pressure, sleep apnea index and sleep quality, resting heart rate and blood pressure, functional capacity, glycosylated hemoglobin, lipid profile, body composition, and health-related quality of life. The trial is conducted at a hospital site with in-person interventions and follow-up assessments.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18–60 who are within one month after bariatric surgery and do not have conditions that contraindicate exercise.
Not a fit: Patients with serious heart disease, respiratory conditions that prevent exercise, significant psychiatric disorders, or orthopedic problems limiting physical activity are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the intervention could strengthen breathing muscles and lead to improved exercise tolerance, sleep quality, and metabolic and cardiovascular measures after bariatric surgery.
How similar studies have performed: Previous studies have shown that respiratory muscle training can improve respiratory function in obese patients, but its broader effects on metabolic, cardiovascular, and exercise-related outcomes after bariatric surgery remain less well documented.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Quito, Pichincha
- Carlos Andrade Marín Hospital — Quito, Pichincha, Ecuador (Recruiting)
Study contacts
- Study coordinator: Jordi Vilaro, Phd
- Email: jordivc@blanquerna.url.edu
- Phone: +34 666580946
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.