Impact of Wearing a Support Garment on Mobility, Functional Capacity, Self-esteem, Quality of Life and Skin Maceration Following Parietal Gastrectomy
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
Sleeve gastrectomy
干预措施: sleeve gastrectomy (Procedure)
Support garment group
Sleeve gastrectomy followed by a period of 12-month with a support garment
干预措施: sleeve gastrectomy (Procedure)
Support garment group
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
Laurent Biertho
Principal Investigator
Laval University
