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临床试验/NCT03641027
NCT03641027已完成不适用

Physical Activity Before Obesity Surgery

Göteborg University2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2016年2月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
2
主要终点
Saltin-Grimby Physical Activity Scale (SGPAS)

研究概览

简要总结

There are limited knowledge about the impact of increased pre-operative physical training on postoperative physical activity levels as well as on recovery and complication rates after bariatric surgery.

The primary aim of this study is to investigate whether an intervention including individual coaching to improve level of physical activity before and after gastric bypass surgery leads to a changed of level physical activity post-operatively at eight weeks, one and two years.

Secondary aims of the study are to investigate whether increased physical activity has effects on complication rates, re-admissions and re-operations, post-operative weight-loss, gastrointestinal pain, recovery measured as hospital stay, sick-leave and QoL, resumption of normal physical activity.

METHODS 300 patients will be recruited and randomized to an intervention group or control group. The patients in the intervention group will receive individual coaching by a physical therapist to:

  • increase physical activity 30 minutes/day (At least 150 min/week)
  • decrease time spent sitting/lying The patients in the control group will receive standard care.

Before surgery, 6 weeks, and one year after surgery patient will fill in a questionnaire including level of physical activity, sick leave, quality of life and gastrointestinal pain. In addition blood test will be taken and complication rates recorded.

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

Assessor will not be aware of which group the patients are included in.

入排标准

性别
All
接受健康志愿者

入选标准

  • Inclusion Criterion:
  • Patients at including hospitals scheduled for gastric bypass surgery

排除标准

  • Inability to understand given information.
  • Inability to perform the intervention

结局指标

主要结局

Saltin-Grimby Physical Activity Scale (SGPAS)

时间窗: From inclusion to 1 year postoperatively

Physical activity level, 1-4 (4 highest activity level).

INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRES (IPAQ)

时间窗: From inclusion 1 year postoperatively

Physical activity level measured in METS (Metabolic Equivalent)

次要结局

  • Blood tests, Blood sugar(From surgery to 2 years postoperatively)
  • Sick-leave(From surgery to at latest 1 year postoperatively)
  • Blood test- Blood lipids(From surgery to 2 years postoperatively)
  • Blood tests, fasting blood suger(From surgery to 2 years postoperatively)
  • Blood tests(From surgery to 2 years postoperatively)
  • Complication rates(From inclusion to 30 days postoperatively)
  • Blood test- glucose metabolism(From surgery to 2 years postoperatively)
  • General Quality of Life, QoL By EQ5D(From inclusion 1 year postoperatively)
  • Gastrointestinal pain by Gastrointestinal Symptom Rating Scale (GSRS)(From inclusion 1 year postoperatively)
  • Weight(From surgery to 2 years postoperatively)
  • Self reported co-morbidity(From inclusion 1 year postoperatively)
  • Length of stay(From surgery to discharge. On average two days)
  • Self reported medication because of co-morbidity(From inclusion 1 year postoperatively)

研究者

发起方
Göteborg University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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