Telerehabilitation-Supported Exercise in Women With Lipedema

Browse trials for

• Lipedema 83
• Motor Activity 2,646
• Pain 2,450

Keywords

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

Lipedema

83 studies on the registry are indexed under Lipedema; 31 are open to participants now.

This study's planned enrollment of 66 is above the median of 35 across 40 interventional studies indexed under Lipedema.

Lead sponsor

Istanbul University is the lead sponsor of 507 studies on the registry; 80 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Study arms

• Experimental
  Telerehabilitation-Supported Exercise Group

  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

• Active comparator
  Home Exercise Group

  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

• OtherTelerehabilitation-Supported Exercise

  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

• OtherHome Exercise Program

  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

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.

   Time frame: Baseline, week 12, week 24

Secondary outcomes

1. Six-Minute Walk Test

   Walking capacity and exercise tolerance will be assessed using the 6-Minute Walk Test in a 30-meter corridor. Participants will be instructed to walk as many laps as possible during 6 minutes. At the beginning of each minute, the assessor will remind the participant of the remaining time and provide standardized verbal encouragement. The total distance walked at the end of 6 minutes will be recorded in meters. A greater walking distance indicates better functional exercise capacity.

   Time frame: Baseline and Week 12, week 24

2. Lower Extremity Function Assessed by Lower Extremity Functional Scale (LEFS)

   Functional capacity during activities of daily living will be assessed using the 20-item Lower Extremity Functional Scale. Each item is scored from 0 to 4: 0 indicates inability to perform the activity or extreme difficulty, 1 indicates quite a bit of difficulty, 2 indicates moderate difficulty, 3 indicates a little difficulty, and 4 indicates no difficulty. The total score ranges from 0 to 80, with higher scores indicating better lower extremity functional capacity.

   Time frame: Baseline and Week 12, week 24

3. Lipedema-Related Symptoms

   The severity of 12 lipedema-related symptoms will be assessed using 10-cm Visual Analog Scales. The evaluated symptoms include pain, tenderness to touch and pressure, swelling, fullness or tightness, heaviness, excessive sensations of heat or cold, easy bruising, fatigue, difficulty walking, reduced quality of life, and dissatisfaction with leg appearance. Each scale ranges from "no symptom" to "the most severe symptom." Higher scores indicate greater symptom severity.

   Time frame: Baseline and Week 12, week 24

4. Pressure Pain Threshold Assessed by Algometry

   Pressure pain threshold will be assessed using a digital algometer. Before measurement, the anterior thigh, pretibial region, lateral aspect of the leg, and medial supramalleolar region of both lower extremities will be marked. The algometer will be applied perpendicular to each measurement point. Participants will indicate when pressure is first perceived as painful, and the value displayed on the device will be recorded as the pressure pain threshold. Measurements will be repeated three times at each point at 5-second intervals, and the mean value will be calculated.

   Time frame: Baseline and Week 12, week 24

5. Lower Extremity Volume Assessed by Circumference Measurements

   Bilateral leg circumference measurements will be obtained while participants are in the supine position. Measurements will begin at the level of the lateral malleolus and continue proximally at 4-cm intervals up to 56 cm. All measurements will be recorded in centimeters. The obtained circumference measurements will be used to calculate total lower extremity and thigh volume according to the principles of the Kuhnke disc method. Percentage changes in volume will be calculated at follow-up assessments.

   Time frame: Baseline and Week 12, week 24

6. Quality of Life Assessed by Short Form-36 (SF-36)

   Quality of life will be assessed using the Short Form-36 Health Survey. The scale consists of eight domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. Each domain is scored from 0 to 100, with higher scores indicating better health-related quality of life. Physical and mental health component scores will also be evaluated.

   Time frame: Baseline and Week 12, week 24

7. Subcutaneous Tissue Thickness Assessed by Ultrasonography

   Subcutaneous tissue thickness will be measured using a MYLAB Esaote 60 ultrasound device with a 7-13 MHz linear transducer while participants are in the supine position. Measurements will be obtained bilaterally from predefined reference areas at the anterior thigh, pretibial region, lateral aspect of the leg, and medial supramalleolar region. The transducer will be positioned perpendicular to the dermal-subcutaneous junction. Three measurements will be obtained from each region, and the mean value will be recorded.

   Time frame: Baseline and Week 12, week 24

8. 30-Second Sit-to-Stand Test

   Lower extremity muscle strength and functional endurance will be assessed using the 30-Second Chair Stand Test. Participants will be instructed to repeatedly stand up from and sit down on a chair with back support while keeping their arms crossed over their chest. The number of correctly completed repetitions within 30 seconds will be recorded. A higher number of repetitions indicates better lower extremity strength and functional endurance.

   Time frame: Baseline and Week 12, week 24

9. Timed Up and Go Test

   Mobility and balance will be assessed using the Timed Up and Go Test. Participants will be instructed to stand up from a chair, walk 3 meters, turn around, walk back to the chair, and sit down. The time required to complete the task will be measured and recorded in seconds. A shorter completion time indicates better functional mobility and balance.

   Time frame: Baseline, Week 12. week 24

Individual participant data

Plan to share: No — Individual participant data will not be shared due to participant confidentiality and data protection considerations.