Muscle Strength and Physical Fitness in Patients With Lipedema and Obesity: a Prospective Cross-sectional Pilot Study
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
- 2
- 主要终点
- The main determinant of this study is a muscle strength test of the Quadriceps muscle of the left and right leg measured with the MircoFET.
研究概览
简要总结
The diagnosis of lipoedema and obesity are often mixed up, unclear stated and often there is a misdiagnosis. The primary aim is to investigate whether there is a difference in muscle strength between women with lipedema and women with obesity. The secondary aim is to investigate whether there is a difference in physical fitness between women with lipedema and women with obesity.
详细描述
Lipedema is a genetically mediated disorder of adipose tissue that occurs exclusively in women. Lipedema is an under-recognized condition, often misdiagnosed as lymfedema or dismissed as simple obesity. The diagnosis of lipedema is a clinical diagnosis and may be challenging to determine among patients who are obese. Measurements of muscle strength and physical fitness may give more clarity to differentiate between lipedema and obesity. This may lead to improvements in the criteria of diagnosing lipedema. The research question of the study is: Is there a difference in muscle strength between adult women with lipedema and adult women with obesity?
In this study 40 patients will be studied; 20 patients in every group. Besides the general data as length, weight, age, abdominal circumference, volume of the legs additional muscle strength and physical fitness of women with lipedema and women with obesity will be measured and analysis.
This study doesn't involve a negligible risk for participants. The study will not have direct benefit for the participants, but may be useful in giving more clarity in defining the phenotype for patients with lipedema.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- •Lipedema group:
- •diagnosed with lipedema following the criteria of Wold et al3
- •age ≥ 18 years
- •Obesity group:
- •age ≥ 18 years
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •Lipedema group:
- •Obesity group:
- •an obesity intervention with physical training in the ≤12 months prior to the measurement
结局指标
主要结局
The main determinant of this study is a muscle strength test of the Quadriceps muscle of the left and right leg measured with the MircoFET.
时间窗: June 2013
Muscle strength will be measured with the MicroFET. This test is performed when de patient is sitting. The patient is instructed to perform knee extension three times for each leg. The test result is de average score of each leg. The MicroFET has been shown to be a valid measurement with the break-method.14,15 Schaubert et al.15 and Bohannon et al.14 looked at the reliability of MicroFET measurements and found a good Intraclass Correlation Coefficient (ICC) values of 0.807-0.97115 and ICC\>.097014 respectively. The test procedure of the break-method is described in Appendix 1).
次要结局
- walking capacity(June 2013)
研究者
R.J. Damstra
Dermatologist MD PhD
Nij Smellinghe Hosptial