Telerehabilitation Versus Supervised Pilates Training in Lipedema Women

NCT06695403 | Active Not Recruiting DMC

• 1 other identifier: 012/005261
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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. 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

Conditions

Lipedema

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

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

Procedure: Pilates Exercise

Interventions

Pilates Exercise PROCEDURE

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

Pilates Exercise (supervised versus telerehabilitation)

Eligibility Criteria

• Age: 35 Years - 45 Years
• Gender Eligibility Details: Females who have lipedema
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of physical therapy

Cairo, Egypt, 3753450, Egypt

Location

MeSH Terms

Conditions

Lipedema

Interventions

Exercise Movement Techniques

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: B.Sc in Physical Therapy. Cairo University (2015). Master Degree in Physical Therapy 2021. Assistant Lecturer of Physical Therapy Suez University

Study Record Dates

• First Submitted: November 16, 2024
• First Posted: November 19, 2024
• Study Start: November 10, 2024
• Primary Completion: March 10, 2025
• Study Completion: September 10, 2025
• Last Updated: November 19, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)