Impact of a Perioperative Physical Exercise and Respiratory Physiotherapy Program on the Patient Undergoing Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Total weight loss
研究概览
简要总结
The goal of this clinical trial is to see the impact of a physical exercise programme and respiratory physiotherapy before and after bariatric surgery in obese patients. The main questions it aims to answer are:
Could it help to avoid decompensation of underlying diseases? Could it reduce the risks associated with the intervention and the number of adverse effects during the postoperative period? Could it reduce the number of patients and encourage early discharge? How does exercise affect epigenetics in obese patients undergoing bariatric surgery? Can we correlate epigenectic markers obtained from tissue obtained by invasive procedures such as fat or muscle to those obtained by non-invasive methods such as blood and saliva samples? How does exercise affect the hepatic tissue in obese patients undergoing bariatric surgery? And are the any predictive markers in pre-exercise samples that can correlate with the evolution of liver diseases such asl NALFD or NASH?
Researchers will compare one group of subjects performing the exercise programme and respiratory physiotherapy and anoher group performing the normal activities of routine clinical practice.
Participants, who are on the surgical waiting list for bariatric surgery, will be assigned to one of the two groups. Participants in group 2 will follow the normal procedure before and after surgery. Participants in group 1 will be asked to do a exercise programme and respiratory physiotherapy before and after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing bariatric surgery at the General and Digestive Surgery Department of the Álvaro Cunqueiro Hospital in Vigo.
- •Be over 18 and under 69 years old.
- •Sign the informed consent to participate in the study.
排除标准
- •Patient's refusal to enter the study.
- •Inability to comprehend participation in a study.
- •Urgent interventions.
- •Patients undergoing combined surgery with another surgical service.
- •Patients who cannot read and write or are dependent on a legal representative.
- •Patients on treatment for diabetes with GLP-1 agonists (glucagon-like peptide type 1 agonists) and/or SGLT2 inhibitors (sodium-glucose cotransporter type 2 inhibitors) whose dose is not stable in the last 3 months.
研究组 & 干预措施
Arm 2
Usual pre- and post-operative procedure without a specific exercise programme.
Arm 1
Specific pre- and post-operative physical exercise and respiratory physiotherapy programme.
干预措施: Pre- and post-operative physical exercise programme (Procedure)
Arm 1
Specific pre- and post-operative physical exercise and respiratory physiotherapy programme.
干预措施: Pre- and post-operative respiratory physiotherapy (Procedure)
结局指标
主要结局
Total weight loss
时间窗: From enrollment to the end of intervention at 8 weeks
\[(Preoperative weight - Weight at 8 weeks post-operative) / Preoperative weight\]\*100
Waist circumference
时间窗: From enrollment to the end of intervention at 8 weeks
Waist circumference measured in cm
Sex (at birth)
时间窗: Once at the inclusion
次要结局
- Beginning of standing(Immediate postoperative period up to 12 hours after surgery)
- EVA of level of subjetive pain felt(The first, second and third day after surgery)
- Morbidity/complications(The fourth day after surgery)
- Re-admission in General and Digestive Surgery Department(8 weeks after discharge)
- Compliance with exercise programme.(8 weeks after discharge)
- Suter oral tolerance test(8 weeks after discharge)
- Surgical Variable: surgical technique(In bariatric surgery)
- Surgical Variable: associated surgery(In bariatric surgery)
- Ferritin(From enrollment to the end of intervention at 8 weeks)
- Surgical Variable: Kind of approach(In bariatric surgery)
- Vitamin B12(From enrollment to the end of intervention at 8 weeks)
- Lactate(From enrollment to the end of intervention at 8 weeks)
- Surgical Variable: urinary catheterisation(In bariatric surgery)
- Surgical Variable: intra-abdominal drainage(In bariatric surgery)
- Goniometry(4 weeks before bariatric surgery)
- Sit to stand Test(From enrollment to the end of intervention at 8 weeks)
- Iron(From enrollment to the end of intervention at 8 weeks)
- Haemoglobin A1c(From enrollment to the end of intervention at 8 weeks)
- Urinary catheterisation(Immediate postoperative period up to 12 hours after surgery)
- Total protein(From enrollment to the end of intervention at 8 weeks)
- Albumin(From enrollment to the end of intervention at 8 weeks)
- Pre-Albumin(From enrollment to the end of intervention at 8 weeks)
- Days from post-operative period to discharge(The fourth day after surgery)
- Emergency attendance in the first 30 days from discharge(8 weeks after discharge)
- Re-intervention during re-admission(8 weeks after discharge)
- Average daily steps(8 weeks after discharge)
- Adverse events during exercise(From enrollment to the end of intervention at 8 weeks)
- Cholesterol(From enrollment to the end of intervention at 8 weeks)
- Triglycerides(From enrollment to the end of intervention at 8 weeks)
- EuroQol 5D (Quality of Life Questionnaire)(From enrollment to the end of intervention at 8 weeks)
- Surgical Variable: revision surgery(In bariatric surgery)
- Surgical Variable: Intraoperative pneumatic compression stockings(In bariatric surgery)
- Surgical Variable: opioid-free anesthetic protocol (OFA)(In bariatric surgery)
- HDL Cholesterol(From enrollment to the end of intervention at 8 weeks)
- LDL Cholesterol(From enrollment to the end of intervention at 8 weeks)
- AST (GOT)(From enrollment to the end of intervention at 8 weeks)
- ALT (GPT)(From enrollment to the end of intervention at 8 weeks)
- GGT(From enrollment to the end of intervention at 8 weeks)
- Alkaline phosphatase(From enrollment to the end of intervention at 8 weeks)
- LDH(From enrollment to the end of intervention at 8 weeks)
- Transferrin(From enrollment to the end of intervention at 8 weeks)
- Transferrin saturation rate(From enrollment to the end of intervention at 8 weeks)
- Folic acid(From enrollment to the end of intervention at 8 weeks)
- Exerkines(From enrollment to the end of intervention at 8 weeks)
- Myokines(From enrollment to the end of intervention at 8 weeks)
- IL(From enrollment to the end of intervention at 8 weeks)
- Grip strength dynamometry(From enrollment to the end of intervention at 8 weeks)
- 6' walk test(From enrollment to the end of intervention at 8 weeks)
- Walking speed test(From enrollment to the end of intervention at 8 weeks)
- IPAQ(From enrollment to the end of intervention at 8 weeks)
- Impedanciometry(4 weeks before bariatric surgery)
- ASA Score(4 weeks before bariatric surgery)
- Baseline O2 Saturation(4 weeks before bariatric surgery)
- Blood glucose(From enrollment to the end of intervention at 8 weeks)
- ARISCAT(4 weeks before bariatric surgery)
- Oral tolerance(Immediate postoperative period up to 12 hours after surgery)
- Use of respiratory incentive(The first day after surgery)
- Surgical Variable: number of trocars(In bariatric surgery)
- Comorbidities(4 weeks before bariatric surgery)
- Age(4 weeks before bariatric surgery)
- Concomitant medication(4 weeks before bariatric surgery)
- Active smoking(4 weeks before bariatric surgery)
- Alcohol consumption(4 weeks before bariatric surgery)
- Previous abdominal surgeries(4 weeks before bariatric surgery)
- Previous bariatric interventions(4 weeks before bariatric surgery)
- Weight at inclusion(4 weeks before bariatric surgery)
- Height at inclusion(4 weeks before bariatric surgery)
研究者
Marta López Otero
Principal Investigator
Fundacin Biomedica Galicia Sur