Effects of Respiratory Muscle Training in Post-bariatric Surgery Patients

Effects of Respiratory Muscle Training on Cardiovascular, Respiratory, Metabolic and Physical Exercise Capacity Parameters Related to Obesity in Post-bariatric Surgery Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Bariatric Surgery
• Intervention / Treatment: Other: simulated inspiratory muscle; Behavioral: Inspiratory muscle training; Behavioral: Institutionalized therapeutic exercise

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.

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jordi Vilaro, Phd; Phone Number: +34 666580946; Email: jordivc@blanquerna.url.edu
• Study Contact Backup: Name: Saúl Caicedo, Msc; Phone Number: +593980290110; Email: saulalejandroct@blanquerna.url.edu

Study Locations

• Ecuador
  • Pichincha
    • Quito, Pichincha, Ecuador, 08025
      • Recruiting
      • Carlos Andrade Marín Hospital
      • Contact: Jessica Pinzón, Dr.; Phone Number: +593983024818; Email: jessica.pinzon@iess.gob.ec
      • Contact: Saul Caicedo, Msc; Phone Number: +593980290110; Email: saul.caicedo@iess.gob.ec
      • Principal Investigator: Saúl Caicedo, Msc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Control Group; The control group will perform inspiratory muscle training with a simulated device 5 times a week for 12 weeks and usual care.	Other: simulated inspiratory muscle; Inspiratory muscle training with sham device, 5 times a week for 12 weeks.
Experimental: 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.	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.
Experimental: 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.	Other: simulated inspiratory muscle; Inspiratory muscle training with sham device, 5 times a week for 12 weeks.; 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.
Experimental: 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.	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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum inspiratory pressure (MIP)	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).	Before and after intervention (12 weeks)
Sleep Apnea	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).	Before and after intervention (12 weeks)
Walking distance	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.	Before and after intervention (12 weeks)
1-minute Sit-to-Stand test	Number of sit-to- stand repetitions done in 1 minute (STS-1m). A 46-cm high chair will be used.	Before and after intervention (12 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep quality	The Pittsburgh sleep quality index (PSQI) assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce 2one global score. The PSQI questions are rated from 0 = no difficulty to 3 = severe difficulty, generating scores that correspond to the domains of the scale. The scores range from 0 to 21 and a score >5 be considered as a significant sleep disturbance.	Before and after intervention (12 weeks)
Resting heart rate	Number of beats in which you pump the least amount of blood necessary, because you are not doing physical activity. This is measured in the number of beats per minute taken at complete rest.	Before and after intervention (12 weeks)
Glycosylated hemoglobin	It´s a blood test that measures the average blood glucose level over the past two to three months, showing the percentage of hemoglobin (the protein that carries oxygen) that has been coated with sugar. Non-diabetic level: ≤ 5.6%; in practice it rules out the diagnosis of diabetes; Prediabetic level (increased risk of diabetes or prediabetes): between 5.7% and 6.4%; Diabetic level: ≥ 6.5%, which is compatible with the diagnosis of diabetes.	Before and after intervention (12 weeks)
Lipid Profile	A lipid profile is a blood test to measure different types of lipids, this is used to determine lipid metabolism as well as the risk of developing cardiovascular pathologies. These include total cholesterol and triglycerides, which are measured in milligrams per deciliter (mg/dL).	Before and after intervention (12 weeks)
Health-related quality of life	Component of quality of life in general that is due to the health care conditions of people and that is referred to from the subjective experiences of patients about their global health. The SF-36 Health Questionnaire is a 36-question instrument used to assess health-related quality of life, from the patient's perspective. It consists of eight scales that measure different aspects of health, such as physical function, physical role, bodily pain, general health, vitality, social function, emotional role, and mental health. Responses are coded and recoded, and results are converted to a scale from 0 to 100, with 0 representing the worst health and 100 the best.	Before and after intervention (12 weeks)
Anxiety and depression	The "HAD questionnaire" refers to the Hospital Anxiety and Depression Scale (HADS), a 14-item questionnaire used to assess emotional distress in patients, particularly those with physical illnesses. It consists of two subscales, one for anxiety and one for depression, which are scored separately to identify the severity of both problems. The total score for each subscale (anxiety and depression) ranges from 0 to 21. Interpretation of results: Anxiety and Depression Subscale: (0-7): Absence of symptoms. (8-10): Doubtful symptoms. (11) or more: Certain symptoms.	Before and after intervention (12 weeks)
Blood pressure	It´s the pressure of circulating blood against the walls of blood vessels. Blood pressure is usually expressed in terms of the systolic pressure (maximum pressure during one heartbeat) over diastolic pressure (minimum pressure between two heartbeats). It is measured in millimetres of mercury (mmHg) above the surrounding atmospheric pressure.	Before and after intervention (12 weeks)
Body Weight	It's a measure of the total mass of your body, including muscle, bone, fat and water, determined by the force of gravity on that mass and usually expressed in kilograms (Kg).	Before and after the intervention (12 weeks)
Body fat percentage	It's the amount of your total body weight that's made up of fat. This can be determined by Bioelectrical Impedance Analysis expressed as a percentage (%).	Before and after the intervention (12 weeks).
muscle mass	It refers to the amount of lean muscle tissue in the body, measured in kilograms, this can be determined through bioelectrical impedance analysis. It is expressed as a percentage (%) of total body weigth.	Before and after the intervention (12 weeks)
Total body water	The body water percentage is the amount of fluid in the body, expressed as a percentage of the total body weight. This can be determined through bioelectrical impedance analysis. It is expressed as a percentage (%) of total body weigth.	Before and after intervention (12 weeks)
Risk of developing obstructive sleep apnea	The STOP-Bang score is a simple and widely used screening questionnaire to assess the risk of developing obstructive sleep apnea (OSA). The questionnaire consists of eight questions with a response of "Yes" which is scored as 1 or "No" which is scored as 0, which translates into a scale from 0 to 8 units. Interpretation of the score: Low risk of OSA: 0 to 2 out of 8 affirmative responses. Intermediate risk of OSA: 3 to 4 out of 8 affirmative responses. High risk for OSA: 5 or more yes answers, or if specific criteria are met, such as answering "Yes" to 2 or more STOP questions plus a large neck circumference or male sex.	Before and after intervention (12 weeks)

Collaborators and Investigators

• Sponsor: University Ramon Llull
• Investigators: Study Chair: Jordi Vilaro, Phd, University Ramon Llull

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: December 4, 2025
• First Submitted That Met QC Criteria: December 4, 2025
• First Posted (Actual): December 17, 2025

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 13, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Bariatric Surgery; Inspiratory muscle training; Therapeutic exercise
• Other Study ID Numbers: 2025-IMTObes

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No