Effects of Respiratory Muscle Training on Cardiovascular, Respiratory, Metabolic and Physical Exercise Capacity Parameters Related to Obesity in Post-bariatric Surgery Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Maximum inspiratory pressure (MIP)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
The randomization system will be carried out by a researcher who is not involved in the evaluation, intervention and data analysis. This researcher will be responsible for providing the respiratory muscle training devices for the different subject groups, delivering them in opaque envelopes.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with obesity within 1 month of bariatric surgery
- •Both sexes
- •Ages 18 to 60
排除标准
- •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
研究组 & 干预措施
Control Group
The control group will perform inspiratory muscle training with a simulated device 5 times a week for 12 weeks and usual care.
干预措施: simulated inspiratory muscle (Other)
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.
干预措施: Inspiratory muscle training (Behavioral)
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.
干预措施: Inspiratory muscle training (Behavioral)
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.
干预措施: simulated inspiratory muscle (Other)
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.
干预措施: Institutionalized therapeutic exercise (Behavioral)
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.
干预措施: Inspiratory muscle training (Behavioral)
结局指标
主要结局
Maximum inspiratory pressure (MIP)
时间窗: Before and after intervention (12 weeks)
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).
Sleep Apnea
时间窗: Before and after intervention (12 weeks)
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).
1-minute Sit-to-Stand test
时间窗: Before and after intervention (12 weeks)
Number of sit-to- stand repetitions done in 1 minute (STS-1m). A 46-cm high chair will be used.
Walking distance
时间窗: Before and after intervention (12 weeks)
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.
次要结局
- Sleep quality(Before and after intervention (12 weeks))
- Resting heart rate(Before and after intervention (12 weeks))
- Lipid Profile(Before and after intervention (12 weeks))
- Health-related quality of life(Before and after intervention (12 weeks))
- Anxiety and depression(Before and after intervention (12 weeks))
- Glycosylated hemoglobin(Before and after intervention (12 weeks))
- Blood pressure(Before and after intervention (12 weeks))
- Risk of developing obstructive sleep apnea(Before and after intervention (12 weeks))
- Body Weight(Before and after the intervention (12 weeks))
- Body fat percentage(Before and after the intervention (12 weeks).)
- muscle mass(Before and after the intervention (12 weeks))
- Total body water(Before and after intervention (12 weeks))