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临床试验/NCT06695403
NCT06695403已完成不适用

Telerehabilitation Versus Supervised Pilates Training on Exercise Capacity and Quality of Life in Lipedema Women

Cairo University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年11月10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
入组人数
60
试验地点
2
主要终点
World Health Organization's Quality of Life questionnaire (WHOQOL BREF):

研究概览

简要总结

  1. Pilates Exercise: The Pilates method is a low-intensity form of movement based on body control, which works the body in a complete way, promoting physical and mental health. PET is different when compared to traditional exercises, which, in turn, tend to isolate the working muscles and have specific training approaches using repetitive motions.
  2. Telerehabilitation: Telehealth is emerging as a key method for delivering essential healthcare. Primary care research suggests that telehealth is acceptable and has potential to overcome geographical barriers for individuals needing many times rehabilitation by eliminating the need for extensive and costly travel
  3. Diet approach: A customized low-carbohydrate high-fat (LCHF) restricted caloric diet in women with lipedema will be used for 12 weeks. The LCHF diet may be a valuable nutritional strategy for lipedema and overweight/obese women, reducing inflammatory status with a beneficial effect on weight, glucose profile the concentration of triglycerides and HDL

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
35 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Sixty female patients diagnosed with lipedema.
  • Their ages will range from 35-45 years old.
  • Patients diagnosed with lipedema ≥ 5 years.
  • Patients with grade 2 and 3 lipedema.
  • Patients with type 2 and 3 lipedema.
  • Patients with BMI ≥ 25 kg/m2
  • All patients will be clinically stable.

排除标准

  • Patient with any of the following will be excluded from the study:
  • Patients with lower limb edematous diseases such as lymphedema or chronic venous insufficiency.
  • Patients with history of previous liposuction.
  • Patients with asymmetrical lower limbs.
  • Patients with history of bariatric surgeries.
  • Patients on weight loss medications.
  • Patients any medical condition prohibiting exercise (cardiac pacemakers, diabetes mellitus, uncontrolled hypertension, and congestive heart failure)
  • Pregnant females.
  • Patients with BMI ≥ 40 kg/m2 (morbid obese).
  • Cancer patients (patients on chemotherapy, immunotherapy radiopathy).
  • Infectious diseases (HIV/AIDS, HCV, and Tuberculosis).
  • Chronic inflammatory autoimmune disease such as Sjogren's syndrome
  • Patients with neurological disorders: stroke and epilepsy.

研究组 & 干预措施

Pilates Exercise (supervised versus telerehabilitation)

Experimental
  1. Pilates Exercise: The Pilates method is a low-intensity form of movement based on body control, which works the body in a complete way, promoting physical and mental health. PET is different when compared to traditional exercises, which, in turn, tend to isolate the working muscles and have specific training approaches using repetitive motions.
  2. Telerehabilitation: Telehealth is emerging as a key method for delivering essential healthcare. Primary care research suggests that telehealth is acceptable and has potential to overcome geographical barriers for individuals needing many times rehabilitation by eliminating the need for extensive and costly travel

干预措施: Pilates Exercise (Procedure)

结局指标

主要结局

World Health Organization's Quality of Life questionnaire (WHOQOL BREF):

时间窗: 12 weeks

The World Health Organization (WHO) has defined "QOL" as "an individual's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns". Recently, many general instruments have been used to measure QOL in different groups (e.g., patients, workers, population and so on). One of these instruments is the World Health Organization QOL-BREF (WHOQOL-BREF) questionnaire which captures many subjective aspects of QOL

Limb Circumference

时间窗: 12 weeks

Limb Circumference: These measurements of definite points diameter in lower extremities using tape measurement are also used to predict progression and as follow up instrument

Six minutes walk test

时间窗: 12 weeks

Procedures for the 6 minute walk test will be adopted from the American Thoracic Society (ATS) guidelines . 6 minute walk test is used to assess exercise tolerance

次要结局

  • World Health Organization's Quality of Life BREF questionnaire (QOL-BREF ).(12 weeks)
  • Limb Circumference(12 weeks)
  • Body mass index (MBI)(12 weeks)

研究者

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

Safaa Salem Salem Shetawy

Assistant Lecturer of Physical Therapy

Cairo University

研究点 (2)

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