The Effect of Systematic Endurance Training in Treatment of Women With Lipedema

NCT06558851 | Active Not Recruiting

• 1 other identifier: 795836
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Lipedema is a chronic adipose tissue disorder that primarily affects women. The etiology remains unclear and involves abnormal buildup of fat mainly in the lower limbs. It causes physical and psychological morbidity, often with significant impact of daily life. Effective treatment options are still limited, primary involving conservative measures such as compression therapy. Regular endurance training is known to have positive effects on pain management in other disorders, as well as beneficial effects on obesity management. Thus, LipidEx aims to explore the potential of high-intensity interval training (HIIT) as a novel therapeutic option for women with lipedema. We will now perform a cross-over randomized controlled trial (RCT) exploring the effects of 12 weeks of HIIT compared to a control period of usual care. Primary outcomes include changes in pain, and secondary outcomes include changes in adipose tissue mass and quality of life. Exploratory outcomes include changes in inflammatory markers, metabolites, and lipoprotein subfractions in blood and adipose tissue.

Conditions

Lipedema

Outcome Measures

Primary Outcomes (1)

• Pain levels

  Pain will be registered before and after both the intervention period and the control period using the RAND-36 health survey (Pain Dimension) (primary endpoint). RAND-36 (also known as SF-36) includes two questions designed to measure the intensity of pain and the extent to which pain interferes with normal work (both outside the home and housework). One of the questions assess the intensity of pain experienced over the past four weeks with six response options from "none" to "very severe". The second question evaluates the degree to which pain has interfered with daily activities and work with five response options from "not at all" to "extremely". I

  Through study completion, an average of 8 weeks

Secondary Outcomes (2)

• Adipose tissue mass

  Through study completion, an average of 8 weeks

• Health-related quality of life

  Through study completion, an average of 8 weeks

Study Arms (2)

Exercise

EXPERIMENTAL

The exercise intervention group perform three sessions of HIIT per week for 12 weeks. HIIT involves 4 times 4-minutes intervals at 85-95% of maximal heart rate (HRmax) with 3-minutes active breaks (\~60% HRmax) between the intervals. Two HIIT sessions are supervised at the NextMove core facility, and performed on treadmills or spinning bikes, while the last session of HIIT is unsupervised. In this unsupervised session, HIIT in a pool will be recommended based on the potential benefits gained from compression. The criteria for adequate compliance to the exercise intervention program will be set to ≥80%.

Behavioral: High intensity endurance training

Control

NO INTERVENTION

In the control period, the participants will live as normal.

Interventions

High intensity endurance training BEHAVIORAL

12 weeks of high intensity endurance training three times a week. Two of the weekly sessions are supervised.

Exercise

Eligibility Criteria

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

You may qualify if:

• Confirmed lipedema diagnosis

You may not qualify if:

• Ongoing eating disorders and/or orthopedic limitations for exercise training

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• St. Olavs Hospital: collaborator

Study Sites (1)

Institute for Circulation and Medical Imaging, NTNU

Trondheim, Norway

Location

MeSH Terms

Conditions

Lipedema

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Øivind Rognmo

  Norwegian University of Science and Technology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: August 19, 2024
• Study Start: September 1, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

NO (1)