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Completed

NCT Number: NCT06695403

Telerehabilitation Versus Supervised Pilates Training in Lipedema Women

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

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Key information

Conditions

Lipedema Connective Tissue Diseases Skin and Connective Tissue Diseases

Age range

35 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of physical therapy

Cairo, Egypt, 3753450

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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.

Treatment and study plan

Pilates Exercise

Procedure
  • 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.
  • 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
  • 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

Primary outcomes

  1. Six minutes walk test

    Time frame: 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

Secondary outcomes

  1. World Health Organization's Quality of Life BREF questionnaire (QOL-BREF ).

    Time frame: 12 weeks

    The World Health Organization (WHO) has defined quality of life 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 Quality of Life BREF questionnaire (WHOQOL-BREF) questionnaire which captures many subjective aspects of QOL

  2. Limb Circumference

    Time frame: 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

  3. Body mass index (MBI)

    Time frame: 12 weeks

    Body mass index (MBI) is used as an indicator for weight reduction

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 19, 2024
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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