Sarcopenia and Related Factors in Lipedema

NCT05739279 | Recruiting

• 1 other identifier: 7416-GOA
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

Lipedema is a common disease of subcutaneous adipose tissue. The most common complaint of patients with swelling in the affected extremity is pain. In addition, patients with lipedema may experience conditions that can greatly affect the health and quality of life of the individual, such as loss of muscle strength and exercise capacity, and deterioration in activity levels of daily living. It is still unknown whether the decrease in muscle strength in patients with lipedema is part of this condition or whether decreased activity levels lead to decreased muscle strength. Sarcopenia is an important health problem characterized by age-related loss of muscle mass and muscle function. The relationship between muscle weakness and sarcopenia in patients with lipedema has not been investigated before. Early recognition of possible sarcopenia and functional limitations in these patients may be important to increase the ability of patients to participate in physical activity as part of their conservative management. There is no study in the literature investigating sarcopenia in patients with a diagnosis of lipedema. The aim of this study is to evaluate patients with a diagnosis of lipedema in terms of sarcopenia. In addition, the relationship between sarcopenia and age, body mass index, exercise frequency, lipedema type, and stage will be investigated in patients diagnosed with lipedema.

Conditions

Lipedema; Sarcopenia; Musculoskeletal Diseases

Keywords

Lipedema; Sarcopenia; Musculoskeletal Diseases

Outcome Measures

Primary Outcomes (3)

• STAR-Sonographic Thigh Adjustment Ratio

  With ultrasonography, anterior thigh muscle thickness on the dominant extremity side will be measured at a 50% level between the anterior superior iliac spine and the upper pole of the patella in the supine position. The STAR-sonographic thigh adjustment ratio will be calculated by dividing the anterior thigh muscle thickness (mm) by the body mass index.

  Day 1

• Hand Grip Strength

  Hand grip strength will be measured with a Jamar dynamometer used in the second grip position, in a sitting position with shoulders adducted and neutrally rotated, elbows flexed to 90°, and forearms/wrists in the neutral position. Three repetitive measurements will be made from the dominant side and the maximum value obtained for analysis will be taken.

  Day 1

• Chair Stand Test

  For the 5-repeat stand-up test, patients will be asked to get up from a chair without an armrest and sit (at the start) five times as fast as possible with their arms crossed over their chest.

  Day 1

Secondary Outcomes (1)

• 6 Meter Gait Speed

  Day 1

Study Arms (2)

Lipedema Group

Patients between the ages of 18-85, diagnosed with lipedema, accepted to participate in the study, and at the appropriate sociocultural level to participate in the study are included in this group.

Diagnostic Test: STAR-Sonographic Thigh Adjustment Ratio; Diagnostic Test: Hand Grip Strength; Diagnostic Test: Chair Stand Test; Diagnostic Test: 6 Meter Gait Speed

Control Group

Those between the ages of 18-85, in an age group similar to the lipoedema group, who agreed to participate in the study, and who were at the appropriate sociocultural level to participate in the study are included in this group.

Diagnostic Test: STAR-Sonographic Thigh Adjustment Ratio; Diagnostic Test: Hand Grip Strength; Diagnostic Test: Chair Stand Test; Diagnostic Test: 6 Meter Gait Speed

Interventions

STAR-Sonographic Thigh Adjustment Ratio DIAGNOSTIC_TEST

With ultrasonography, anterior thigh muscle thickness on the dominant extremity side will be measured at a 50% level between the anterior superior iliac spine and the upper pole of the patella in the supine position. The STAR-sonographic thigh adjustment ratio will be calculated by dividing the anterior thigh muscle thickness (mm) by the body mass index.

Control Group; Lipedema Group

Hand Grip Strength DIAGNOSTIC_TEST

Hand grip strength will be measured with a Jamar dynamometer used in the second grip position, in a sitting position with shoulders adducted and neutrally rotated, elbows flexed to 90°, and forearms/wrists in the neutral position. Three repetitive measurements will be made from the dominant side and the maximum value obtained for analysis will be taken.

Control Group; Lipedema Group

Chair Stand Test DIAGNOSTIC_TEST

For the 5-repeat stand-up test, patients will be asked to get up from a chair without an armrest and sit (at the start) five times as fast as possible with their arms crossed over their chest.

Control Group; Lipedema Group

6 Meter Gait Speed DIAGNOSTIC_TEST

For walking speed measurements, patients will be asked to stand with both feet touching the starting line and walk at their normal speed on a 6-meter track after the command. The time between the start and end will be measured with a stopwatch and converted to meters/second. Three consecutive measurements will be made for both and average values will be taken for the analyses.

Control Group; Lipedema Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Descriptive, cross-sectional, case-control

You may qualify if:

• between the ages of 18-85
• with a diagnosis of lipoedema
• who agreed to participate in the study
• having a sociocultural level suitable for participation in the study
• healthy volunteers in a similar age group for the control group

You may not qualify if:

• with chronic venous insufficiency and/or lymphedema
• with Parkinson's disease, previous stroke, cerebellar diseases, multiple sclerosis, major depression, neuromuscular diseases, history of major orthopedic surgery, severe hip/knee osteoarthritis, rheumatological diseases, malignancies, advanced heart/liver/renal failure, visual impairment, and vestibular diseases, and those who use any assistive device to walk
• who are illiterate and have cognitive impairment that will prevent them from giving written consent will not be included in the study

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Department of Physical Medicine and Rehabilitation, Medical Faculty of Dokuz Eylül University, İzmir, Turkey

Izmir, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Lipedema; Sarcopenia; Musculoskeletal Diseases

Interventions

Hand Strength

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Muscle Strength; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Nihan Erdinc Gunduz, M.D.

  Dokuz Eylul University

  STUDY DIRECTOR

Central Study Contacts

Nihan Erdinc Gunduz, M.D.

CONTACT

+905063992614; nihanerdinc@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 12, 2023
• First Posted: February 22, 2023
• Study Start: January 1, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 12, 2025

Record last verified: 2024-08

Locations

TU (1)