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临床试验/NCT04938310
NCT04938310终止不适用

Impact of Wearing a Support Garment on Mobility, Functional Capacity, Self-esteem, Quality of Life and Skin Maceration Following Parietal Gastrectomy

Laval University1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2021年10月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
6
试验地点
1
主要终点
Physical activity

研究概览

简要总结

Custom-made orthopedic support equipment and abdominal-lumbar support belts offer promising potential for several aspects affecting the health and well-being of people with obesity who choose a surgical weight loss option. However, research is needed to quantitatively document their short and long term effects on a wide range of parameters related to mobility, quality of life, lower back pain and skin maceration following parietal gastrectomy. The objective of this study is to characterize the effect of a support garment in an experimental design where a subgroup of participants will be randomized and followed for the first 12 months after a gastrectomy. The measures will be: physical activity, lower back pain, self-esteem, quality of life, skin maceration and infections. This study will scientifically document the usefulness and effectiveness of support garments throughout the weight loss surgery process.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •meeting the NIH criteria for bariatric surgery
  • •BMI >= 35 kg/m2

排除标准

  • •chronic pulmonary obstructive disease
  • •gastric stoma
  • •psychiatric disease contraindicated for bariatric surgery

研究组 & 干预措施

Control Group

Active Comparator

Sleeve gastrectomy

干预措施: sleeve gastrectomy (Procedure)

Support garment group

Experimental

Sleeve gastrectomy followed by a period of 12-month with a support garment

干预措施: sleeve gastrectomy (Procedure)

Support garment group

Experimental

Sleeve gastrectomy followed by a period of 12-month with a support garment

干预措施: support garment (Device)

结局指标

主要结局

Physical activity

时间窗: From baseline to 12 month following sleeve gastrectomy

Physical activity evaluated by wearing an activity monitor

Body image

时间窗: From baseline to 12 month following sleeve gastrectomy

Gender-specific body-size guide is a pictorial method of assessing the perception of weight status. It consists of 10 standardized images of adults with known BMI values and is a validated body size perception tool. The scale is gender specific and images range from underweight (BMI \<18.5) to class III obesity (BMI\> = 40) with approximately a 3 point difference in BMI between the figures on the scale.

marital satisfaction

时间窗: From baseline to 12 month following sleeve gastrectomy

Dyadic adjustment scale, scores are from 0 to 151, higher score indicates a higher level of marital functioning

Excess skin

时间窗: From baseline to 12 month following sleeve gastrectomy

Excess skin measured with the Iglesias scale, scores are from 1 to 5, higher score means a worse excess skin

adherence in wearing the support garment

时间窗: From baseline to 12 month following sleeve gastrectomy

adherence in wearing the support garment evaluated with an adherence journal. Adherence will be calculated as a percentage from the total number of days the participant wears the garment out of the total for the intervention.

Body composition

时间窗: From baseline to 12 month following sleeve gastrectomy

body fat composition assessed by impedance

Impact of excess skin

时间窗: From baseline to 12 month following sleeve gastrectomy

Sahlgrenska Excess Skin questionnaire assesses excess skin after weight loss for specific body parts and body as a hole. Inconvenience of excess skin is evaluated on a scale from 0 to 10, higher score means higher perception that the excess skin is an inconvenience.

Social Physique Anxiety

时间窗: From baseline to 12 month following sleeve gastrectomy

Social Physique Anxiety Scale, scores are from 12 to 60, higher score means more anxiety

social ideals of physical appearance

时间窗: From baseline to 12 month following sleeve gastrectomy

Sociocultural Attitude Towards Appearance Questionnaire-4 contains 6 subscales (internalization: thinness / low fat mass, internalization: muscular, internalization: general attractiveness, pressures: family, pressures: media, pressures: similar and other significant). Scores are from 1 to 5, higher scores indicating greater internalization and endorsement of societal appearance ideals

Severity of depression symptoms

时间窗: From baseline to 12 month following sleeve gastrectomy

Beck Depression Inventory II questionnaire, scores are from 0 to 63, higher score means more severe depressive symptoms.

Anxiety

时间窗: From baseline to 12 month following sleeve gastrectomy

State-Trait Anxiety Inventory contains 2 subscales for usual emotional state and current emotional state. Scores are from 20 to 80, higher scores means higher anxiety state.

Quality of life

时间窗: From baseline to 12 month following sleeve gastrectomy

Laval questionnaire contains 6 subscales for symptoms, activity/mobility, personal hygiene/clothing, emotions, social interactions, and sex life. scores are from 1 to 7, higher score means higher quality of life in each domain

persistence in wearing the support garment

时间窗: From baseline to 12 month following sleeve gastrectomy

persistence in wearing the support garment will be calculated as a percentage by reporting the number of participants who have stopped wearing the garment compared to those who have used it.

Skin maceration

时间窗: From baseline to 12 month following sleeve gastrectomy

maceration evaluated with an in-house questionnaire reported as presence or absence of skin maceration

Skin infection

时间窗: From baseline to 12 month following sleeve gastrectomy

infection evaluated with an in-house questionnaire reported as presence or absence of skin infection

Lower back pain

时间窗: From baseline to 12 month following sleeve gastrectomy

Quebec back pain scale, scores are from 0 to 100, higher score means greater difficulty in carrying out activities due to low back pain

Self esteem

时间窗: From baseline to 12 month following sleeve gastrectomy

Rosenberg self esteem scale, scores are from 10 to 40, higher score mean a stronger self esteem

Self esteem related to physical appearance

时间窗: From baseline to 12 month following sleeve gastrectomy

Body Esteem Scale for Adolescent and Adults contains 3 subscales for weight, appearance and attribution. Scores are from 1 to 5, higher score means higher self esteem.

gastroesophageal reflux disease

时间窗: From baseline to 12 month following sleeve gastrectomy

GastroEsophageal Reflux Disease Score, scores are from 0 to 96, higher score indicates worse gastroesophageal reflux symptoms

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Laurent Biertho

Principal Investigator

Laval University

研究点 (1)

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