Telerehabilitation-Supported Exercise in Women With Lipedema

NCT07885241 | Not Yet Recruiting

• 1 other identifier: E-29624016-050.99-3909371
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, single-blind, randomized controlled trial aims to evaluate the effectiveness of a telerehabilitation-supported exercise program in women with lipedema. A total of 66 women aged 18 to 65 years with stage I-III lipedema will be included and randomly assigned to either the telerehabilitation group or the home exercise group. Participants in the telerehabilitation group will perform a supervised exercise program delivered synchronously via Zoom three times per week for 12 weeks. Participants in the control group will perform a similar home-based exercise program independently three times per week for 12 weeks. Both groups will receive education about lipedema and instructions regarding the exercise program. The primary outcome is pain intensity assessed using the Visual Analog Scale (VAS). Secondary outcomes include pressure pain threshold, lipedema-related symptoms, lower-extremity volume, subcutaneous tissue thickness, body composition, functional capacity, mobility, quality of life, and exercise adherence.

Conditions

Lipedema

Keywords

telerehabilitation; exercise; pain; functional status; quality of life; lipoedema; physical rehabilitation

Outcome Measures

Primary Outcomes (1)

• Pain Intensity Assessed by Visual Analog Scale (VAS)

  Pain severity in the affected extremities will be assessed using a 10-cm Visual Analog Scale. The scale ranges from "no pain" to "the most severe pain imaginable." Participants will be asked to mark the point on the line that best represents the severity of their pain. The distance from the beginning of the scale to the marked point will be measured and recorded as the pain score. Higher scores indicate greater pain severity.

  Baseline, week 12, week 24

Secondary Outcomes (9)

• Six-Minute Walk Test

  Baseline and Week 12, week 24

• Lower Extremity Function Assessed by Lower Extremity Functional Scale (LEFS)

  Baseline and Week 12, week 24

• Lipedema-Related Symptoms

  Baseline and Week 12, week 24

• Pressure Pain Threshold Assessed by Algometry

  Baseline and Week 12, week 24

• Lower Extremity Volume Assessed by Circumference Measurements

  Baseline and Week 12, week 24

Study Arms (2)

Telerehabilitation-Supported Exercise Group

EXPERIMENTAL

Participants in this group will receive a telerehabilitation-supported exercise program delivered synchronously via Zoom three times per week for 12 weeks. The program includes warm-up, strengthening, and cool-down exercises. Participants will also receive education about lipedema and written exercise materials

Other: Telerehabilitation-Supported Exercise

Home Exercise Group

ACTIVE COMPARATOR

Participants in this group will perform a similar home-based exercise program independently three times per week for 12 weeks. They will receive education about lipedema, written exercise materials, and an exercise monitoring form

Other: Home Exercise Program

Interventions

Home Exercise Program OTHER

A home-based exercise program performed independently three times per week for 12 weeks. The exercise content is similar to the telerehabilitation group and participants receive education about lipedema, written exercise materials, and an exercise monitoring form

Home Exercise Group

Telerehabilitation-Supported Exercise OTHER

A supervised exercise program delivered synchronously via Zoom three times per week for 12 weeks. The program consists of warm-up, strengthening, and cool-down exercises. Strengthening exercises are performed at approximately 50-60% of one-repetition maximum with progression during the intervention period. Participants also receive education about lipedema and written exercise materials

Telerehabilitation-Supported Exercise Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female participants with a clinical diagnosis of lipedema confirmed according to the revised Wold criteria
• Stage I-III lipedema
• Age between 18 and 65 years
• Body mass index ≤40 kg/m²
• No cardiac, pulmonary, or orthopedic medical contraindication to exercise
• Ability to use a smartphone, tablet, or computer and access to an active internet connection
• Ability and motivation to participate regularly in telerehabilitation sessions
• Willingness to participate voluntarily and provide written informed consent
• Ability to ambulate independently on level surfaces without an assistive device or assistance from another person

You may not qualify if:

• Presence of systemic disease that may prevent safe participation in exercise, including uncontrolled cardiovascular, metabolic, or pulmonary disease; neurological, hematological, or rheumatological disease; or malignancy
• Musculoskeletal pathology that may limit exercise performance, including advanced knee or hip osteoarthritis, severe deformity, or acute muscle or joint injury
• Pregnancy or breastfeeding
• Acute infection, open skin lesion, skin ulcer, or advanced lipodermatosclerosis
• Liposuction or major surgery within the previous three months
• Participation in physical therapy or a regular exercise program within the previous three months
• Severe psychiatric or cognitive disorder that may interfere with treatment adherence

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University, Istanbul Faculty of Medicine

Istanbul, Fatih, 34080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lipedema; Motor Activity; Pain

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ekin Ilke SEN, MD

  Istanbul University, Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mehri Guner, MD

CONTACT

+905428125439; mehriguner@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor is blinded to group allocation. The randomization list is concealed from the assessor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Two-arm parallel randomized controlled trial comparing telerehabilitation-supported exercise with a home exercise program.

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: October 21, 2026
• Study Start: October 19, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: October 21, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)