Effects of Exercise in Patients with Lipedema

February 2, 2025 updated by: Ilke Keser

Effects of Exercise on Edema, Pain, Exercise Capacity, Lower Extremity Muscle Strength and Function in Patients with Lipedema

Lipedema is a chronic progressive disease characterized by symmetrical, disproportionate swelling of subcutaneous adipose tissue, which is common in women and mostly seen in the lower extremities and to a lesser extent in the upper extremities. Healthy lifestyle approaches including exercise treatments are very important for lipedema patients in order to prevent disease progression. The aim of this study is to investigate the effects of exercise on edema, pain, exercise capacity, lower extremity muscle strength and function in lipedema patients. Sociodemographic information of the patients, body composition with Tanita InnerScan BC-601-CG device, clinical information regarding lipedema, type and stage of lipedema, inspection, palpation findings will be recorded. Local tissue water percentage will be assessed using Moisturemeter-d compact (MMDc, Delfin Technologies, Kuopio, Finland) device, circumference measurement using tape, pain intensity with Visual Analog Scale, pain threshold with Baseline brand digital algometer device. Muscle strength will be assessed using K-Force hand dynamometer. Functional exercise capacity will be assessed with the 6-minute walk test (6MWT), and lower extremity dysfunction with the lower extremity functional scale. After the assessments are made, the patients will be randomly divided into 2 groups. The patients in the study group will perform group exercises consisting of warm-up, loading and cool-down periods of 40-50 minutes, 2 days a week for 6 weeks, and strengthening exercises applied to the hip muscles and knee extensors with elastic resistance bands, which are decided according to the level of effort perceived by the patient, 3 sets of 10 repetitions, 2 days a week for 6 weeks. The same assessments will be applied to the patients again at the end of the exercise program. The control group will be re-evaluated after 6 weeks with suggestions regarding lipedema and physical activity level, and the obtained data will be compared.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Elif Sakizli Erdal, Doctor of Philosophy
  • Phone Number: + 90 506 436 6991
  • Email: sakizlielif@gmail.com

Study Locations

  • Turkey
    • Emek
      • Ankara, Emek, Turkey, 06490
        • Recruiting
        • Gazi University Faculty of Health Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Having a diagnosis of Lipedema,
  • Patients with Lipedema stage 1,2 and 3

Exclusion Criteria:

  • Individuals with cardiopulmonary, rheumatic or neurological diagnoses that have symptoms severe enough to prevent participation in exercise,
  • History of cancer, surgery or trauma that may affect the circulatory system,
  • History of liposuction or orthopedic surgery within the last year,
  • Individuals who cannot mobilize independently.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Exercise group
Patients with lipedema will perform group exercises consisting of warm-up, loading and cool-down periods of 40-50 minutes, 2 days a week for 6 weeks, and strengthening exercises applied to the muscles around the hips and knee extensors with elastic resistance bands, determined according to the effort level perceived by the patient, 3 sets of 10 repetitions, 2 days a week for 6 weeks.
Behavioral: Exercise
Patients with lipedema will perform group exercises consisting of warm-up, loading and cool-down periods of 40-50 minutes, 2 days a week for 6 weeks, and strengthening exercises applied to the muscles around the hips and knee extensors with elastic resistance bands, determined according to the effort level perceived by the patient, 3 sets of 10 repetitions, 2 days a week for 6 weeks.
Other: Control group
The control group will be given recommendations regarding lipedema and physical activity level.
Behavioral: Physical activity
The control group will be given recommendations regarding lipedema and physical activity level.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Local tissue water percentage
Time Frame: 6 weeks
Local tissue water percentage will be measured with the Moisturemeter-d compact (MMDc, Delfin Technologies, Kuopio, Finland) device. This device calculates the percentage of water under the skin by touching the reference points from the skin surface. 3 measurements will be made for each reference point and the average of these measurements will be recorded. The reference points were determined as the medial of 35 cm above the heel (calf) on both legs, the medial of 3 cm proximal to the patella (medial knee) and the lateral of 20 cm above the line drawn from 3 cm proximal to the patella to the SIAS (lateral hip).
6 weeks
edema
Time Frame: 6 weeks
For the lower extremity, the circumference will be measured at 4 cm intervals starting from the lateral malleolus to the highest point that can be reached on the inner thigh. The circumference measurement is performed while the patient is lying on his back. The results are recorded in cm and the volume calculation will be made according to the Khunke disk method.
6 weeks
Pain severity
Time Frame: 6 weeks
The leg pain due to lipedema will be recorded in cm with the Visual Analog Scale (VAS) according to the patient's statement.
6 weeks
Pain Threshold
Time Frame: 6 weeks
A Baseline brand digital algometer device will be used to assess the pain threshold. A 1 cm2 probe will be used for measurements. Before the measurement process, the midpoint of the quadriceps and tibia will be marked. The measurement will be repeated three times at 5-second intervals and the average values will be recorded in kg. The algometer will be placed at a right angle to each point, the participants will be asked to report the presence of pain by saying "yes" and the value on the device will be recorded as the pain threshold when they first feel pain at the point of touch. There will be a 5-second break between measurements.
6 weeks
Lower extremity muscle strength
Time Frame: 6 weeks
Muscle strength measurements will be made with K-Force hand dynamometer. Quadriceps Femoris and hip flexors muscle strength will be measured in sitting position and hip abductors muscle strength will be measured in side-lying position. During the measurements, patients will be asked to perform maximum isometric contraction for 5 seconds. Muscle strength measurements will be repeated 3 times on the right and left sides separately and maximum value will be recorded in kg.
6 weeks
Lower extremity muscle endurance
Time Frame: 6 weeks
Lower extremity muscle endurance measurement will be evaluated with a 30-second sit-to-stand test. The patient will be asked to stand up and sit down from a back-supported chair with their arms crossed on both shoulders for 30 seconds. Sitting down and standing less than 10 times in 30 seconds indicates a loss of lower extremity strength.
6 weeks
functional exercise capacity
Time Frame: 6 weeks
Exercise capacity will be evaluated with a 6-minute walking test. The distance covered will be recorded and interpreted as normal values. Heart rate and oxygen saturation will be measured with a portable pulse oximeter before and after the test; blood pressure will be measured with a device that automatically measures (Omron-Hem 710 Int, USA). Dyspnea and fatigue levels will be evaluated with the Modified Borg Scale (MBS) at the beginning and end of the test. The Modified Borg Scale is a scale that evaluates fatigue and shortness of breath between 0-10.
6 weeks
lower extremity function
Time Frame: 6 weeks
The lower extremity functional scale is a questionnaire consisting of 20 items developed to evaluate the lower extremity functions of patients. There are 5 options from 0 to 4 for each question (0: Extreme difficulty or inability to perform the activity, 1: Quite a bit of difficulty, 2: Moderate difficulty, 3: Some difficulty, 4: No difficulty at all). The total score varies between 0-80 and higher scores indicate better functional status.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ilke Keser

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 5, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 5, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 5, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 26, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ElifSakizliLipedema

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

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