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临床试验/NCT04413812
NCT04413812已完成不适用

Fostering Exercise After Bariatric Surgery

Lia Bally1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Change from baseline in physical activity-related health competence.

研究概览

简要总结

While the benefits of engagement in regular physical activity after bariatric surgery has been established in various studies, little is known about the effectiveness of an interdisciplinary intervention including nutritional and psychological advice, hands-on training experience and motivational education to promote long-term adherence to a self-motivated active lifestyle in the bariatric surgery population.

This randomized pilot intervention study called Fostering Exercise After Bariatric Surgery (FREEBASE) explores the efficacy of an interdisciplinary approach to promote physical activity-related health competence and an active lifestyle after bariatric surgery.

详细描述

Bariatric surgery is quickly emerging as a standard treatment for people with obesity stage II and III (BMI ≥35 kg/m2) because of its beneficial long-term effects on body weight and obesity-related comorbidities. In Switzerland, approximately 5,000 bariatric surgeries are performed every year. There is a growing body of evidence demonstrating that engagement in physical activity benefits the bariatric surgery population in many aspects. These entail the prevention of surgery-induced metabolic complications such as sarcopenia and osteopenia on the one hand, but also the mitigation against the commonly observed weight regain and relapse of metabolic comorbidities. Despite these obvious health benefits, inactivity and poor health literacy are common problems amongst people who underwent bariatric surgery. Although the Swiss healthcare system offers well designed post-operative follow-up programmes, exercise is currently not to being considered. Additionally the lower educational level of bariatric surgery patients is a well known problem. Addressing physical activity-related health competence and self-empowerment in this population currently remains an unmet need.

Previous studies investigating exercise interventions in the bariatric surgery population have demonstrated efficacy on metabolic outcomes but also indicated that adherence wanes over time. To overcome the challenge of changing lifestyle in a sustainable way, individuals need to have a complex set of abilities, skills, knowledge, motivation and willingness. In Germany, diverse models have been developed to describe this specific set of competences, all inspired by the concept of health literacy, which is internationally recognised in research and clinical practice.

Physical activity-related health competence comprises three components: (1) Movement competence, enabling individuals to meet the movement-related requirements of physical activities (e.g. motor abilities, motor skills for cycling or gymnastics) (2) control competence for physical activity enabling people to gear their own activity to achieve positive effects in health and well-being, and (3) physical activity-specific self-regulation competence enabling individuals to be regularly active, which involves both motivational and volitional factors. The relevance of physical activity-related health competence for the promotion of an active lifestyle has been demonstrated in various studies in healthy and physical inactive adults at metabolic risk. However, the concept has not yet been addressed in the bariatric surgery population. The investigators therefore hypothesize, that targeting the various components of physical activity-related health competence by means of a comprehensive exercise programme has the potential to result in a more effective promotion of physical activity in the bariatric surgery population, thereby benefitting their long-term health and well-being.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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
是

入选标准

  • •Aged ≥18 years
  • •Bariatric surgery within the past 1-6 months according to the guidelines of the Swiss Society for the Study of Morbid Obesity and Metabolic Disorders (SMOB)
  • •Willingness to comply with study-related activities
  • •Literate in German

排除标准

  • •Incapacity to give informed consent
  • •Contraindication to participation in the study exercise programme as judged by the clinical investigator or treating physical
  • •Physical or physiological condition likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the clinical investigator or treating physical
  • •Evidence of malnutrition as judged by the clinical investigator or treating physician
  • •Pregnancy, planned pregnancy, or breast feeding (females of childbearing potential are advice to use safe-contraception for up to 18 months post-bariatric surgery as part of usual care)
  • •Illicit or prescription drug abuse

研究组 & 干预措施

Experimental Group

Experimental

The experimental group will participate in a 3-months training programme focusing on health competence related outcomes.

干预措施: FREEBASE exercise programme (Behavioral)

Control Group

No Intervention

The control group does not participate in the exercise programme but undergoes identical outcome assessments.

结局指标

主要结局

Change from baseline in physical activity-related health competence.

时间窗: The questionnaires will be completed at baseline, after completion of the exercise program (visit 2, at 10-12 weeks) and at the follow-up (visit 3, at 16-18 weeks).

The physical activity-related health competence will be assessed using items from different areas (self-efficacy, self-control, emotional attitudes, cognitive attitudes, motivational competence, control of physical load, affect regulation). A composite score will be calculated as the mean score of the individual areas. For each area, the mean score of its items assessed on a 5-point Likert scale ranging from 1 (does not apply at all) to 5 (does apply exactly) will be calculated.

次要结局

  • Absolute change in Time (s) in the "Timed up and go" test.(The test will be conducted at baseline and at visit 2 (after 10-12 weeks).)
  • Absolute change in Time (s) in the "Unilateral hip bridge" test(The test will be conducted at baseline and at visit 2 (after 10-12 weeks).)
  • Absolute change in 6-min walking distance (m)(The test will be conducted at baseline and at visit 2 (after 10-12 weeks).)
  • Relative change from baseline in physical activity level.(Physical activity will be measured during one week at baseline and during one week at follow-up (visit 3, at 16-18 weeks).)
  • Change from baseline in self-reported physical activity.(The questionnaires will be completed at baseline, after completion of the exercise program (visit 2, at 10-12 weeks) and at the follow-up (visit 3, at 16-18 weeks).)
  • Change from baseline in self-reported sport and exercise activity.(The questionnaires will be completed at baseline, after completion of the exercise program (visit 2, at 10-12 weeks) and at the follow-up (visit 3, at 16-18 weeks).)

研究者

发起方
Lia Bally
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Lia Bally

Professor

Insel Gruppe AG, University Hospital Bern

研究点 (1)

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