Effects of Respiratory Muscle Training in Post-bariatric Surgery Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Institutionalized therapeutic exercise, Inspiratory muscle training, simulated inspiratory muscle.
- Who it may be relevant to
- Registry conditions: Bariatric Surgery. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Ecuador
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of Respiratory Muscle Training on Cardiovascular, Respiratory, Metabolic and Physical Exercise Capacity Parameters Related to Obesity in Post-bariatric Surgery Patients
Overview
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.
Interventions
- 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.
Primary outcome measures
- Maximum inspiratory pressure (MIP) [Time frame: Before and after intervention (12 weeks)]
- Sleep Apnea [Time frame: Before and after intervention (12 weeks)]
- 1-minute Sit-to-Stand test [Time frame: Before and after intervention (12 weeks)]
- Walking distance [Time frame: Before and after intervention (12 weeks)]
Secondary outcome measures (12)
- Sleep quality [Time frame: Before and after intervention (12 weeks)]
- Resting heart rate [Time frame: Before and after intervention (12 weeks)]
- Blood pressure [Time frame: Before and after intervention (12 weeks)]
- Glycosylated hemoglobin [Time frame: Before and after intervention (12 weeks)]
- Lipid Profile [Time frame: Before and after intervention (12 weeks)]
- Body Weight [Time frame: Before and after the intervention (12 weeks)]
- Body fat percentage [Time frame: Before and after the intervention (12 weeks).]
- muscle mass [Time frame: Before and after the intervention (12 weeks)]
- Total body water [Time frame: Before and after intervention (12 weeks)]
- Health-related quality of life [Time frame: Before and after intervention (12 weeks)]
- Anxiety and depression [Time frame: Before and after intervention (12 weeks)]
- Risk of developing obstructive sleep apnea [Time frame: Before and after intervention (12 weeks)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Ecuador · 1 center
- Carlos Andrade Marín Hospital — Quito
Identifiers
NCT: NCT07289958 · 2025-IMTObes