The Effect of Systematic Endurance Training in Treatment of Women With Lipedema - The LipidEx Study

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Confirmed lipedema diagnosis

Locations
Other Locations
Norway
Institute for Circulation and Medical Imaging, NTNU
RECRUITING
Trondheim
Contact Information
Primary
Anja Bye, PhD
anja.bye@ntnu.no
+47 932 32 057
Time Frame
Start Date: 2025-09-01
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 62
Treatments
Experimental: Exercise
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%.
No_intervention: Control
In the control period, the participants will live as normal.
Related Therapeutic Areas
Sponsors
Leads: Norwegian University of Science and Technology

This content was sourced from clinicaltrials.gov