NCT06889207进行中（未招募）不适用
Physical Exercise Prehabilitation Program in MEtabolic SuRgery
Flevoziekenhuis1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2022年3月14日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- six-minute walk test
研究概览
简要总结
The goal of this clinical trial is to learn if an exercise program before bariatric surgery works to treat obesity, could improve physical condition and weight loss before bariatric surgery and induce a lifestyle behavior change. The main questions it aims to answer are:
- Does a supervised exercise program lead to improved physical condition prior to bariatric surgery?
- Does a supervised exercise program prior to bariatric surgery lead to reduced surgery related complications?
- Does a supervised exercise program prior to bariatric surgery lead to maintained lifestyle changes after surgery?
Participants will:
- Receive either no training program or physical exercise training program twice a week, supervised by a physical therapist, for a duration of 8 weeks.
- Have their fitness measured at the start and at the end of the 8 weeks, measured with a six minute walking test.
- Fill in a survey on their perceived quality of life and exercise habits at the start of the trial, and at 1 year 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
- Treatment
- 盲法
- None
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
- •Adult patients (≥18 years)
- •Body-Mass-Index (BMI) 40 kg/m2 or higher, or 35 kg/m2 or higher with the presence of at least one comorbidity (type 2 diabetes, high blood pressure, heart and/or vascular diseases, obstructive sleep apnea (OSA), dyslipidemia, or arthritis).
- •Primary bariatric patients; without previous bariatric surgery. For inclusion the investigators will follow the National Guidelines on metabolic surgery.
排除标准
- •Patients with:
- •mobility problems (patients who are not able to exercise)
- •cognitive disabilities
- •illiteracy (patients who are not able to read and understand the language of the country where the study will be performed)
研究组 & 干预措施
Prehabilitation
Active Comparator
Patients in the intervention group will have two supervised training sessions per week for eight weeks in group sessions supervised by a physiotherapist.
干预措施: Physical exercise prehabilitation (Behavioral)
No prehabilitation
No Intervention
Receives no exercise prehabilitation program
结局指标
主要结局
six-minute walk test
时间窗: 2 months
Preoperative physical condition, assessed by using the six-minute walk test (6MWT). The target increase of the 6MWT is 10% in the intervention group.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
撤回
不适用
Exercise Training Study Before Bariatric SurgeryBariatric Surgery CandidateNCT06274606University of Virginia
尚未招募
不适用
Outcomes of a Pre-operative Exercise Programme for Live Donor and Recipient Kidney Transplant PatientsKidney TransplantKidney Transplant DonorKidney Transplant RecipientNCT06858098University of Manchester40
已完成
不适用
The FEMA Study: Feasibility of Exercise in Patients With Metastatic Breast Cancer and AdiposityAdiposityEstrogen-receptor-positive Breast CancerMetastatic Breast CancerNCT06343987Aarhus University Hospital21
Unknown
不适用
Exercise Prior to OesophagectomyOesophageal AdenocarcinomaPostoperative Complications (Cardiopulmonary)NCT02962219University of East Anglia32
已完成
不适用
Preoperative Exercise in Pancreatic CancerPancreatic CancerNCT02648880University of Colorado, Denver3