The Effects of Endurance Training in Women With Lipedema
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Visual analog scale (VAS)
研究概览
简要总结
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.
详细描述
Methods
Subjects 30 women diagnosed with lipedema age 18-65 will be randomized to (1:1) to 8 weeks of exercise training og a control group. Exclusion criteria includes ongoing eating disorders and/or orthopedic limitations for exercise training. A compliance with the training program of 80% will also be set as a criterion for completing the study. Participants will be recruited via social media, via physiotherapists, via posters at GPs and via a user representative from the Norwegian Lymphedema and Lipedema Association (NLLF). The master's students will obtain informed consent cf. GCP and the Health Research Act. The potential participants will have at least one week to consider their participation. If a research participant should be injured on the basis of something the investigators ask them to do, NTNU will have the insurance responsibility. The investigators will collect data on the type and stage of lipedema, when the participant was diagnosed. The investigators will also collect data on which clinical aids they are using and how often, e.g., compressions aids.
Intervention - Training protocol The women will be randomized (1:1) to 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 at the NextMove core facility at NTNU or to a control group. All participants will be provided with a pulse watch to keep after the study is completed. In addition, the participants will perform exercise once a week on their own following the correct exercise intensity. Pool training will be recommended based on potential benefits from compression. Body composition, blood pressure, VO2max (maximal oxygen uptake), questionnaire data and blood samples will be measured/collected before and after the exercise intervention. The participants will write a diary for their physical activity using standardized templates from the NextMove core facility.
Maximal oxygen uptake (VO2max) 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) as described earlier.11 A warm-up period for 10 min (~60% of HRmax) will precede the test. A levelling off of oxygen uptake (VO2) despite increased work load and respiratory exchange ratio ≥1.05 will be used as criteria for VO2max. HR will be measured continuously during the test (Polar, Polar Electro, Kempele, Finland), to define HRmax.
Anthropometric measurements Body weight, body mass index and waist-to-hip ratio will be measured. Body composition will be measured using InBody. For measurement of body composition, the investigators will use an instrument called Inbody 720 (Body Analysis AS). Inbody 720 provides weight, muscle mass, fat percentage, metabolism and mineral status non-invasively by sending weak electrical signals through the body. The whole test lasts just a few minutes. Before the analysis the participants should be fasten at least two hours and should avoid strenuous exercise. The standard procedures at NextMove will be used to measure the weight and height of participants. The height will be measured without shoes or head wear, this must be done with equal weight on both legs. The distance between the legs shall be a foot. The heels should be in the ground at full stretch their legs. The height is measured with one decimal. The weight is measured without heavy clothes and shoes, while the participants are standing still. It will be drawn 0.5 kg for the remaining clothes. The weight is measured with one decimal. The participants must stand upright for measuring of waist and hip circumference and a regular exhaust measuring the circumference one cm over the navel. The waist circumference is measured with no decimals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •can meet for supervised exercise training in Trondheim.
排除标准
- •eating disorders and/or orthopedic limitations for exercise training
结局指标
主要结局
Visual analog scale (VAS)
时间窗: Change from baseline to 8 weeks
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.
次要结局
- Diastolic blood pressure(Change from baseline to 8 weeks)
- Short Form Health Survey-36 (SF-36)(Change from baseline to 8 weeks)
- Total cholesterol(Change from baseline to 8 weeks)
- Protein levels in blood(Change from baseline to 8 weeks)
- Triglycerides(Change from baseline to 8 weeks)
- HDL-cholesterol(Change from baseline to 8 weeks)
- HbA1C(Change from baseline to 8 weeks)
- Systolic blood pressure(Change from baseline to 8 weeks)
- LYMQOL (Lymphoedema Quality of Life) legs(Change from baseline to 8 weeks)
- Brief Pain Inventory(Change from baseline to 8 weeks)
- Interleukin(Change from baseline to 8 weeks)
- TNFalpha(Change from baseline to 8 weeks)
- Muscle mass(Change from baseline to 8 weeks)
- Resting metabolism(Change from baseline to 8 weeks)
- Glucose(Change from baseline to 8 weeks)
- Ferritin(Change from baseline to 8 weeks)
- hs-CRP(Change from baseline to 8 weeks)
- PF4/CXCL4(Change from baseline to 8 weeks)
- Body weight(Change from baseline to 8 weeks)
- Fat percentage(Change from baseline to 8 weeks)
- Maximal oxygen uptake(Change from baseline to 8 weeks)