Effects of Physical Exercise in Postoperative Bariatric Surgery Patients
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Six minutes walk test (mts traveled)
研究概览
简要总结
This study aims to determine the effect of two types of exercise training on body composition, cardiopulmonary function and quality of life in people after undergoing bariatric surgery.
详细描述
Three groups will be studied:
- Control group (CG)
- Group of moderate intensity continuous aerobic exercise (GMICT)
- High intensity interval aerobic exercise group (GHIIT)
The CG will follow the usual protocol adopted by the hospital San Juan de Dios, Curicó, Chile. The protocol consists in delivering information about relevance of engage in regular physical exercise practice according to the World Health Organization (150 minutes of activity per week moderate physical or at least 75 minutes of intense physical activity), but do not include the patients in a supervised physical exercise program.
The GMICT will undergo a physical exercise program in which the aerobic component will be a moderate-intensity continuous exercise training (60% of the heart rate reserve).
The GHIIT will undergo the same exercise program of the GMICT, but the aerobic component will be a high-intensity interval exercise training (10 sets of 1 min at 90% of heart rate reserve, with 1 min of rest between sets).
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
- Single (Outcomes Assessor)
盲法说明
The outcomes assessor will be blinded to the study intervention the participants were submitted.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persons between 18 and 65 years old, both sexes, who have undergone bariatric surgery, with medical authorization to perform physical exercise, that the wound healing process operative is in the final phase, which have been administered with subsequent anti thrombus treatment to surgery, who have no plans to change their place of residence within the current year.
排除标准
- •Persons who have had immediate complications after bariatric surgery (dehiscence anastomosis and operative wound dehiscence), presented any comorbidity decompensation after surgery, who are in the process of dialysis or who suffer from neuromotor disease.
研究组 & 干预措施
Control Group (CG)
The CG will receive the standard indications routinely provided by the hospital which consists in information about practice of regular physical activity according to World Health Organization. A leaflet with illustrations and indications will be provided and will be explained by the principal investigator.
Moderate-intensity continuous exercise training group (GMICT)
The GMICT will be submitted to a physical exercise program in which the aerobic component will be a moderate-intensity continuous exercise training, performed at 60% of the heart rate reserve, two days a week, for 30 minutes.
干预措施: Physical Exercise (Other)
High-intensity interval training exercise group (GHIIT)
The GHIIT will be will be submitted to a physical exercise program in which the aerobic component will be a high-intensity interval exercise training, performed in a protocol consisted of four one-min sprint at 90% of the heart rate reserve, alternated with one-min rest (at week 1) and progressing until reach 10 bouts of one-min sprint alternated with one-min rest.
干预措施: High-intensity interval training performed at cycle ergometer. (Other)
结局指标
主要结局
Six minutes walk test (mts traveled)
时间窗: 16 weeks
To determine the effects of HIIT and MCIT on functional capacity using the six-minute walk test.
Bone mass (Kg)
时间窗: 16 weeks
To determine the effects of HIIT and MCIT on body composition by measuring bone mass using a tetrapolar bioelectrical impedance.
Body fat (%)
时间窗: 16 weeks
To determine the effects of HIIT and MCIT on body composition by measuring percent of body fat using a tetrapolar bioelectrical impedance.
Muscle mass (Kg)
时间窗: 16 weeks
To determine the effects of HIIT and MCIT on body composition by measuring muscle mass using a tetrapolar bioelectrical impedance.
Moorehead-Ardelt Quality of Life Questionnaire (MAQ II)
时间窗: 16 weeks
To determine the effects of HIIT and MCIT on quality of life by the Moorehead-Ardelt Quality of Life Questionnaire. The score of each answer ranges from -0.5 (most unfavorable situation) to +0.5 (most favorable situation). According to the score obtained: -3 to -2.1: "very poor"; -2 to -1.1: "poor"; -1 to 1: "fair"; 1.1 to 2: "good"; and 2.1 to 3: "very good" quality of life.
Heart rate variability
时间窗: 16 weeks
To determine the effects of HIIT and MCIT on cardiac autonomic control in supine and orthostatic positions.
Bariatric Analysis and Reporting Outcomes System (BAROS Score)
时间窗: 16 weeks
To determine the effects of HIIT and MCIT on quality of life by the Bariatric Analysis and Reporting Outcomes System. Moorehead-Ardelt questionnaire incorporates the percentage of overweight lost or gained after surgery, resolution of comorbidities associated with morbid obesity, need for reoperation and complications. According to the score obtained, it is categorized as: ≤1: "failure"; \> 1 to 3: "fair"; \> 3 to 5: "good"; \> 5 to 7: "very good"; and \> 7 to 9: excellent.
次要结局
- Flowmeter (L/min)(16 weeks)
- Hand grip strength test (Kg)(16 weeks)
- 30-sec chair stand test (count)(16 weeks)
- Maximal inspiratory and expiratory pressures (cmH2O)(16 weeks)
研究者
Antonio Roberto Zamunér
Adjunct Professor - Principal Investigator
Universidad Católica del Maule