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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
52
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 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.
Inspiratory muscle training with sham device, 5 times a week for 12 weeks.
Carlos Andrade Marín Hospital
Quito, Pichincha, Ecuador
RECRUITINGMaximum 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Before and after intervention (12 weeks)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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 (%).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Before and after intervention (12 weeks)
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