Prehabilitation in Bariatric Surgery: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Weight change
研究概览
简要总结
Obesity is a major public health problem in our region and constitutes a priority of the Canary Islands Health Plan. Bariatric surgery is the most effective intervention in the treatment of obesity and its complications. However, people with obesity have high surgical risk and long-term outcomes are related to pre-surgical weight loss.
In patients currently on the bariatric surgery waiting list, a randomized controlled trial will be performed in which two group interventions will be compared. One of the interventions (standard), will consist of educational modules in food and exercise, combined with cognitive-behavioral therapy. In the other, a specific training (prehabilitation) will be added to encourage physical activity and the conditioning of inspiratory muscles.
The pre-surgical weight loss (principal outcome) will be compared between groups, as well as the evolution of the complications of obesity, the functional status of the patients, their physical activity, quality of life, immediate complications of surgery and days of admission.
详细描述
Obesity is a major public health problem, responsible for an increased risk of hypertension, obesity, dyslipidemia, type 2 diabetes, cardiovascular disease, some types of cancer, psychiatric diseases and mortality.
Bariatric surgery has proven to be the most effective method for reducing weight and related comorbidities in patients with morbid obesity. However, pre-surgical weight loss reduces postsurgical complications. In addition, weight loss before surgery seems to be the only factor positively associated with post-surgical weight loss, and this effect seems to be more pronounced in patients with BMI> 45 kg / m2.
Pre-operative physical conditioning (prehabilitation) can improve the patient's functional capacity before major surgery. Most studies showing this have been conducted in orthopedic surgery and abdominal cancer surgery. There are very few studies that evaluate prehabilitation in patients undergoing bariatric surgery.
Objective
Comparison of a multidisciplinary group intervention with another one to which specific training focused on increasing physical activity is added, in patients on the surgical waiting list for bariatric surgery in a randomized controlled trial.
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
- Double (Participant, Outcomes Assessor)
盲法说明
A person external to the monitoring and evaluation of the patients will generate a random sequence (by computer), to assign the participants to their corresponding treatment group. The intervention sequence will be transcribed to cards that will be introduced in an envelope each. The envelopes will be opaque, sealed and numbered consecutively. Each time a patient agrees to participate in the trial, he/she signs the informed consent and we verify that he/she meets the inclusion criteria, but not the exclusion criteria, the corresponding envelope will be opened in correlative order.
Patients will be assigned to one of two group interventions, unaware of the components in each group. The assessment of most of the outcomes will be blinded, too.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •People with obesity (type II-IV), on the waiting list for bariatric surgery in the Complejo Hospitalario Universitario Materno-infantil de Las Palmas
排除标准
- •any factor that, in the opinion of the researchers, limits the ability to monitor the intervention (language barrier, ...).
研究组 & 干预措施
Intervention
Educational program and cognitive-behavioral intervention. The patient receives training in nutrition and cognitive-behavioral therapy, with specific training aimed at increasing physical activity, functional capacity and conditioning of the respiratory musculature (prehabilitation by a physiotherapist)
干预措施: Prehabilitation (Behavioral)
Control
Educational program and cognitive-behavioral intervention. The patient receives training in nutrition and cognitive-behavioral therapy, as well as standard instructions to increase physical activity.
干预措施: Control (Behavioral)
结局指标
主要结局
Weight change
时间窗: 4-6 months
Increase (or decrease) in weight between the start of the program and the time of surgery (measured on a calibrated scale, with Maximum increments of 0.1Kg, under the same conditions, without footwear and with light clothing)
次要结局
- Body mass index(4-6 months)
- Associated complications-lipids(4-6 months)
- Adherence to the intervention(4-6 months)
- Physical activity-self reported(4-6 months)
- Body composition(4-6 months)
- Associated complications-Blood pressure(4-6 months)
- Associated complications-treatments(4-6 months)
- Eating patterns-eating disorders(4-6 months)
- Associated complications-glucose metabolism(4-6 months)
- Associated complications-liver enzymes(4-6 months)
- Eating patterns-Adherence to Mediterranean diet(4-6 months)
- Functional capacity-respiratory muscle strength(4-6 months)
- Functional capacity-sleep apnea polygraph(4-6 months)
- Physical activity-steps(4-6 months)
- General health status(4-6 months)
- Emotional state(4-6 months)
- Functional capacity-walk test(4-6 months)
- Functional capacity- grip strength(4-6 months)
- Surgery-length of admission(5-7 months after start of intervention)
- Subjective evaluation of satisfaction, perceived effort and motivation(4-6 months)
- Functional capacity-plethysmography(4-6 months)
- Functional capacity-Spirometry(4-6 months)
- Functional capacity-sleep apnea questionnaire(4-6 months)
- Surgical complications(5-7 months after start of intervention)
研究者
Rosa María Sánchez Hernández
Attending Physician
Hospital Universitario Insular Gran Canaria