Telerehabilitation Versus Supervised Pilates Training in Lipedema Women

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

Study Overview

• Status: Active, not recruiting
• Conditions: Lipedema
• Intervention / Treatment: Procedure: Pilates Exercise

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 3753450
    • Faculty of Physical Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

Patient with any of the following will be excluded from the study:

1. Patients with lower limb edematous diseases such as lymphedema or chronic venous insufficiency.
2. Patients with history of previous liposuction.
3. Patients with asymmetrical lower limbs.
4. Patients with history of bariatric surgeries.
5. Patients on weight loss medications.
6. Patients any medical condition prohibiting exercise (cardiac pacemakers, diabetes mellitus, uncontrolled hypertension, and congestive heart failure)
7. Pregnant females.
8. Patients with BMI ≥ 40 kg/m2 (morbid obese).
9. Cancer patients (patients on chemotherapy, immunotherapy radiopathy).
10. Infectious diseases (HIV/AIDS, HCV, and Tuberculosis).
11. Chronic inflammatory autoimmune disease such as Sjogren's syndrome
12. Patients with neurological disorders: stroke and epilepsy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Pilates Exercise (supervised versus telerehabilitation); 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

Procedure: Pilates Exercise; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Six minutes walk test	Procedures for the 6MWT will be adopted from the American Thoracic Society (ATS) guidelines . 6MWT is used to assess exercise tolerance	12 weeks
World Health Organization's Quality of Life questionnaire (WHOQOL BREF):	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	12 weeks
Limb Circumference	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	12 weeks

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2024
• Primary Completion (Estimated): March 10, 2025
• Study Completion (Estimated): September 10, 2025

Study Registration Dates

• First Submitted: November 16, 2024
• First Submitted That Met QC Criteria: November 16, 2024
• First Posted (Estimated): November 19, 2024

Study Record Updates

• Last Update Posted (Estimated): November 19, 2024
• Last Update Submitted That Met QC Criteria: November 16, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Connective Tissue Diseases; Lipedema
• Other Study ID Numbers: 012/005261

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No