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

Design This study will follow the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) reporting guidelines.

Study design and participants We will conduct a crossover randomized controlled trial (RCT) involving 58 women diagnosed with lipedema. To be eligible for participation, women must be between 18 and 65 years old and have a confirmed diagnosis of lipedema. Exclusion criteria include ongoing eating disorders and orthopedic limitations that prevent exercise training. Eligible participants will be randomized (1:1) using block randomization in eForsk to either the exercise intervention group or the control group. The exercise intervention group will undergo 12 weeks of high-intensity interval training (HIIT), tailored to each participant's fitness level and the severity of their lipedema. The control group will continue their usual lifestyle during this period. Following the 12-week intervention, there will be a 12-week wash-out period during which all participants will resume their normal activities. After the wash-out period, participants will switch groups, allowing all included participants to receive the exercise intervention and potentially experience the benefits of HIIT. In total, the study duration for each participant will be 9 months.

Recruitment Patients will be recruited in Trøndelag, Norway, primarily through The Clinic of Rehabilitation at St. Olavs Hospital and the social media channels of the Norwegian Lymphedema and Lipedema Foundation (NLLF). Additionally, posters will be displayed at general practitioner offices and various physiotherapy clinics in the Trondheim area. Eligible patients will receive comprehensive information about the study and will be given at least one week to consider their participation.

Exercise intervention Exercise testing and training will be conducted at state-of-the-art exercise training facility at the Norwegian University of Science and Technology (NTNU), the NextMove Core facility, supported by highly experienced staff. 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%. With standardized templated from the NextMove core facility, the participants are required to write a diary of their physical activity during the entire study period, including the exercise intervention period, the wash-out period, and the control period.

Data collection During the first study visit, participants will be randomized into groups and receive comprehensive information about the study and all included procedures. Data collection will occur primarily on four separate test days: before and after both the exercise intervention period and the control period. On these test days, anthropometric and physiological measurements will be taken, questionnaires will be completed, and fasting blood samples and tissue biopsies will be collected.