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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05488977
Other study ID # 461077
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 1, 2022
Est. completion date December 31, 2026

Study information

Verified date June 2024
Source Norwegian University of Science and Technology
Contact Anja Bye
Phone +4793232057
Email anja.bye@ntnu.no
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Lipedema is a fat disorder causing accumulation of subcutaneous adipose tissue particularly in arms and legs, and predominantly affects women. Lipedema likely contributes to an array of other pathologies, including obesity, inflammatory bowel disease, and neurological disorders. Lipedema tissue is often very painful and can severely impair mobility. The condition can also increase the incidence of depression, anxiety, or eating disorders. There seems to be a general impression that lipedema tissue is difficult to reduce by diet, exercise, or bariatric surgery. However, only a few studies have actually explored the effects of exercise training on lipedema. Despite the lack of knowledge, the existing guidelines for lipidemia treatment promote a healthy lifestyle with individually adjusted weight control measures, including physical activity. In general, exercise is known to have an important effect on adipose tissue. Excess adipose tissue causes macrophage infiltration into the adipose tissue leading to continuous low systemic inflammation. This would suggest that there is a systemic inflammatory response in lipedema patients. Increasing IL-6 levels with exercise can decrease the level of proinflammatory TNFalpha synthesized from adipocytes and therefore lead to an anti-inflammatory effect by increasing IL-10 and IL-1ra levels. IL-6 also stimulates fat oxidation by increasing lipolysis. For these reasons, adding an appropriate exercise program to standard treatment might provide additional benefits for lipedema patients. The investigators aim to determine the therapeutic potential of high-intensity interval training (HIIT) on pain, quality of life, body composition, cardiorespiratory fitness and circulating biomarkers in women with lipedema.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Exercise training
8 weeks of supervised high-intensity interval training (HIIT).

Locations

Country Name City State
Norway Institute for Circulation and Medical Imaging, NTNU Trondheim

Sponsors (2)

Lead Sponsor Collaborator
Norwegian University of Science and Technology St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visual analog scale (VAS) Visual analog scale (VAS), measured by means of a 0-100 mm, for pain will be used to collect data on pain. VAS has been used in the social and behavioral sciences to measure a variety of subjective phenomena. A VAS is a straight line, whose end anchors indicate the extreme boundaries of the sensation, feeling, or responses to be measured. For example, a VAS to measure pain can be labeled "no pain" on one end and "pain as bad as it could possibly be" on the other end. Subjects respond to the VAS by placing a mark through the line at a position which best represents their current perception of a given phenomenon between the labeled extremes. Although a VAS may be horizontal or vertical and of any length deemed appropriate, its most common form is a 100 mm horizontal line. The VAS is scored by measuring the distance, usually in millimeters, from one end of the scale to the subject's mark on the line. Change from baseline to 8 weeks
Secondary LYMQOL (Lymphoedema Quality of Life) legs Self-reported questionnaire reporting quality of life adapted to lipedema patients.
This questionnaire has been designed and validated for patients with chronic oedema/ lymphoedema of one or both legs to measure quality of life. The patients will tick the box that best describes how they feel about each of the questions.The questionaire includes 22 main questions. The patient may tick one of the following; "Not at all", "A little", "Quite a bit" or "A lot". The last question includes a scale. The title of the scale is "Overall, how would you rate your quality of life at present?". The minimum value is 0 and mean Poor, whereas the maximum value is 10 and means Excellent.
Change from baseline to 8 weeks
Secondary Brief Pain Inventory Self-reported questionnaire reporting pain. The Brief Pain Inventory is a validated, widely used, self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions. The title of the scale is pain. The BPI scale defines pain as follows:
Worst Pain Score: 1 - 4 = Mild Pain. Worst Pain Score: 5 - 6 = Moderate Pain. Worst Pain Score: 7 - 10 = Severe Pain.
Change from baseline to 8 weeks
Secondary Short Form Health Survey-36 (SF-36) Self-reported questionnaire reporting quality of life. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. Change from baseline to 8 weeks
Secondary Glucose Serum levels of glucose Change from baseline to 8 weeks
Secondary HbA1C Serum levels of HbA1C Change from baseline to 8 weeks
Secondary Triglycerides Serum levels of triglycerides Change from baseline to 8 weeks
Secondary HDL-cholesterol Serum levels of HDL-cholesterol Change from baseline to 8 weeks
Secondary Total cholesterol Serum levels of total cholesterol Change from baseline to 8 weeks
Secondary Ferritin Serum levels of ferritin Change from baseline to 8 weeks
Secondary hs-CRP Serum levels of hs-CRP Change from baseline to 8 weeks
Secondary Interleukin Serum levels of interleukin Change from baseline to 8 weeks
Secondary PF4/CXCL4 Serum levels of PF4/CXCL4 Change from baseline to 8 weeks
Secondary TNFalpha Serum levels of TNFalpha Change from baseline to 8 weeks
Secondary Protein levels in blood Aprox. 200 proteins will be quantified (mmol/l) in blood by nuclear magnetic resonance. Change from baseline to 8 weeks
Secondary Systolic blood pressure Systolic blood pressure Change from baseline to 8 weeks
Secondary Diastolic blood pressure Diastolic blood pressure Change from baseline to 8 weeks
Secondary Body weight Body weight based on InBody 720 Change from baseline to 8 weeks
Secondary Muscle mass Total muscle mass and in different parts of the body based on InBody 720 Change from baseline to 8 weeks
Secondary Fat percentage Total fat percentage and in different parts of the body based on InBody 720 Change from baseline to 8 weeks
Secondary Resting metabolism Whole body resting metabolism based on InBody 720 Change from baseline to 8 weeks
Secondary Maximal oxygen uptake VO2max will be measured during uphill treadmill walking or running (Woodway PPS 55 Med, Munich, Germany), using ergospirometry (Jaeger, Oxycon pro, Hoechberg, Germany / Meta Max II, Cortex, Leipzig, Germany) Change from baseline to 8 weeks
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