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 negative impact on daily life. Effective treatment options are still limited, primarily involving conservative treatment such as compression therapy and pain reliever. As endurance training is shown to have beneficial effects on both pain and obesity management in patients suffering of other disorders, LipidEx aims to explore the potential of high-intensity interval training (HIIT) as a novel therapeutic option for women with lipedema. We will perform a cross-over randomized controlled trial (RCT) exploring the effects of 12 weeks of HIIT compared to a control period of usual care. The primary outcome is changes in pain, and secondary outcomes are changes in adipose tissue mass and quality of life.
Competing Interest StatementThe authors have declared no competing interest.
Clinical TrialNCT06558851
Funding StatementThe study will be supported by grants from the DAM Foundation Joint Research Committee between St. Olavs hospital and the Faculty of Medicine and Health Sciences, NTNU (FFU). The funders have/had no role in study design, data collection and analysis, decision to publish or preparation of the manuscript.
Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.
Yes
The details of the IRB/oversight body that provided approval or exemption for the research described are given below:
This is a protocol paper for Registered Report, and not a full manuscript. The Regional Ethics committee (REK) of Norway have given ethical approval to preform the LipidEx-study.
I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.
Yes
I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).
Yes
I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.
Yes
Data AvailabilityAll data produced will be available online.
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