The Metabolic and Respiratory Effects of Intermittent Hypoxia-hyperoxia Therapy in Obese Patients Within the Complex Management of Medical Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Metabolic effects
研究概览
简要总结
Obesity represents the excessive or abnormal accumulation of adipose tissue in the body, which affects health through its association with the risk of developing diabetes mellitus, cardiovascular and pulmonary diseases and hypertension.
Obesity can cause significant respiratory changes, so obese patients present pulmonary complications more frequently than individuals with normal weight.
Intermittent hypoxia (IH) represents the alternation between repeated episodes of hypoxia interspersed with normoxic episodes. Intermittent hypoxia-hyperoxia is the therapy that uses hyperoxic intervals instead of normoxic ones between hypoxic breathing sessions.
This study aimed to evaluate the effectiveness of intermittent hypoxia-hyperoxia therapy among obese patients, focusing on metabolic and respiratory effects. The study aimed to determine if this method could bring benefits in managing or alleviating the complications associated with obesity.
A total of 70 obese patients will be recruited and randomized to either the IHHT group or the control group. The intervention group will receive IHHT while the control group will not receive this therapy.
All patients will be assessed at baseline and after 2 weeks of treatment using a variety of clinical and functional measures. The study's results will be used to determine whether IHHT benefits the patients who follow it.
This study is designed to contribute to the existing body of knowledge on treating obese patients. The results of the study will be of interest to clinicians, researchers, and patients.
详细描述
The study was a prospective, randomized controlled, unicentric study conducted at the Balneal and Rehabilitation Sanatorium Techirghiol (BRST) in Romania. A total of 70 obese patients (BMI > 30 kg/m2) were enrolled in the study. The patients were randomly assigned to either the IHHT group or the control group.
Patients in the intervention group received intermittent hypoxia-hyperoxia therapy and patients in the control group did not receive this therapy. Simultaneously with the intermittent hypoxia-hyperoxia therapy, the patients benefited from complex balneo-physical-kinetic treatment which included hydrokinetotherapy and hydrothermotherapy using specific natural environmental factors: sapropelic mud and salt water from Lake Techirghiol, electrotherapy, massage therapy and kinetotherapy.
The 35 patients in the IHHT group underwent intermittent hypoxia-hyperoxia therapy using the CellOxy Device. During the hypoxic phases, patients received concentrations of 9-16% O2, while during the hyperoxic phases, approximately 35% O2 was administered.
During both testing and actual therapy sessions, patients remained in a comfortable position, lying on a bed. Initially, patients performed hypoxic tests 1 and 2, to determine the optimal oxygen level and to be included in a typology (type I, II, or III). Based on the obtained data, the device automatically calculated and planned personalized IHHT sessions for each patient.
Starting from the following day, patients in the IHHT group were subjected to intermittent hypoxia-hyperoxia as follows: hypoxia with 9-16% O2 for 5-7 minutes, followed by exposure to hyperoxia with ~35% O2 for 2-5 minutes. During the sessions, both SpO2 and heart rate were constantly monitored using the device's built-in pulse oximeter.
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
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with BMI >30 kg/m2
- •aged between 40-75 years
- •patients to sign the informed consent form
- •patients to be compensated and to have medical treatment for associated pathologies
排除标准
- •BMI <30 kg/m2
- •age under 40 or over 75 years
- •refusal to sign the informed consent form
- •patients presenting contraindications to intermittent hypoxia-hyperoxia therapy
- •patients presenting contraindications to complex medical rehabilitation treatment
结局指标
主要结局
Metabolic effects
时间窗: Two measurements, at the beginning of treatment and after 2 weeks of treatment.
Blood sampling (urea, uric acid, creatinine, glucose, total cholesterol). The Units of Measure for these biomarkers = mg/dL.
次要结局
- Respiratory effects(Two measurements, at the beginning of treatment and after 2 weeks of treatment.)
研究者
Elena-Valentina Ionescu
Assit. Prof. Dr. Ionescu Elena Valentina
Balnear and Rehabilitation Sanatorium Techirghiol