Effects of Respiratory Muscle Training in Post-bariatric Surgery Patients
ConditionBariatric Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity Ramon Llull
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients diagnosed with obesity within 1 month of bariatric surgery
Both sexes
Ages 18 to 60
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Institutionalized therapeutic exercise
BehavioralPhysical 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
BehavioralInspiratory 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 interventionInspiratory muscle training with sham device, 5 times a week for 12 weeks.
Treatment groups
52 Participants
are divided into 4 treatment groupsGroup A: Control GroupSham comparator 1 intervention
Group B: Inspiratory muscle trainingExperimental treatment 1 intervention
Group C: Institutionalized therapeutic exercise + simulated inspiratory muscle trainingExperimental treatment 2 interventions
Group D: Institutionalized therapeutic exercise + inspiratory muscle trainingExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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).
Time frame
Before and after intervention (12 weeks)2
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)3
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)4
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)Secondary outcomes
1
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)2
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)3
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)4
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)Sponsors and contacts
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Source ClinicalTrials.gov