The Effects of Endurance Training on Lipedema

NCT05488977 | Completed

• 1 other identifier: 461077
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lipedema

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (21)

• LYMQOL (Lymphoedema Quality of Life) legs

  Change from baseline to 8 weeks

• Brief Pain Inventory

  Change from baseline to 8 weeks

• Short Form Health Survey-36 (SF-36)

  Change from baseline to 8 weeks

• Glucose

  Change from baseline to 8 weeks

• HbA1C

  Change from baseline to 8 weeks

Study Arms (2)

Exercise training

EXPERIMENTAL

8 weeks of supervised high-intensity interval training (HIIT) that is 4×4 min intervals at 85-95% of maximal heart rate (HRmax) with 3-minute active breaks (\~60 % HRmax) in between intervals, twice a week) on treadmills. In addition, the participants will perform exercise once a week on their own following the correct exercise intensity.

Behavioral: Exercise training

Control

NO INTERVENTION

No intervention. Carry on their normal life.

Interventions

Exercise training BEHAVIORAL

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

Exercise training

Eligibility Criteria

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

You may qualify if:

• \- can meet for supervised exercise training in Trondheim.

You may not qualify if:

• 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

Interventions

Exercise

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Øivind Rognmo, PhD

  Norwegian University of Science and Technology

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: July 8, 2022
• First Posted: August 5, 2022
• Study Start: July 1, 2022
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: July 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)