LipedemaNCT06695403
Telerehabilitation Versus Supervised Pilates Training in Lipedema Women
A study testing Pilates Exercise in people with Lipedema, run by Cairo University at 1 site in Egypt.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 35 to 45 years, women only
- Conditions the study is for
- Lipedema
- What is being tested?
- Pilates Exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Nov 2024to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Telerehabilitation Versus Supervised Pilates Training on Exercise Capacity and Quality of Life in Lipedema Women
- 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 triglycerides and HDL
- Conditions
- Lipedema
- Being tested
- Pilates Exercise
- Medical subject headings
- Lipedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates ExerciseProcedure or surgery
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Pilates Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six minutes walk test
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
Measured: 12 weeks
Secondary outcomes (3)
World Health Organization's Quality of Life BREF questionnaire (QOL-BREF ).
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
Measured: 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
Measured: 12 weeks
Body mass index (MBI)
Body mass index (MBI) is used as an indicator for weight reduction
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start10 Nov 2024
- Primary completion1 Mar 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LipedemaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Safaa Salem Salem Shetawy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06695403
- Sponsor's protocol ID
- 012/005261
- Status last verified
- Jun 2024
- First submitted
- 16 Nov 2024
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telerehabilitation Versus Supervised Pilates Training on Exercise Capacity and Quality of Life in Lipedema Women
- ClinicalTrials.gov ID
- NCT06695403
- Acronym / sponsor ID
- 012/005261
- Conditions
- Lipedema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Nov 2024 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 19 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 triglycerides and HDL
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pilates Exercise (supervised versus telerehabilitation) | Experimental | Procedure: Pilates Exercise1. 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 |
Who may qualify
- Ages
- 35 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pilates Exercise1. 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 | Procedure or surgery | Pilates Exercise (supervised versus telerehabilitation) |
Primary outcome
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
3 secondary outcomes
World Health Organization's Quality of Life BREF questionnaire (QOL-BREF ).
Time frame: 12 weeks
Limb Circumference
Time frame: 12 weeks
Body mass index (MBI)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates Exercise in people with Lipedema, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six minutes walk test (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.