Comparison of Different Exercise Protocols for Diagnosed With Lipedema

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• Lipedema 83

Keywords

• lipedema
• aerobic exercise training
• functional capacity
• muscle strength
• quality of life

Lipedema

83 studies on the registry are indexed under Lipedema; 31 are open to participants now.

This study's planned enrollment of 66 is above the median of 35 across 40 interventional studies indexed under Lipedema.

Lead sponsor

Hitit University is the lead sponsor of 84 studies on the registry; 30 are open to participants now.

Study arms

• Experimental
  High-Intensity Interval Aerobic Exercise Group

  High-intensity interval lower-extremity aerobic exercise training will be performed on a cycle ergometer for a total duration of 35 minutes. The exercise protocol will consist of a 5-minute warm-up period at 50% of maximum heart rate, a 4 × 4-minute high-intensity training period at 80-95% of maximum heart rate, a 3 × 3-minute active recovery period at 70% of maximum heart rate, and a 5-minute cool-down period at 50% of maximum heart rate.

  Other: High-Intensity Interval Aerobic Exercise Group

• Experimental
  Moderate-Intensity Continuous Aerobic Exercise Group

  Moderate-intensity continuous lower-extremity aerobic exercise training will be performed on a cycle ergometer for a total duration of 35 minutes. The exercise protocol will consist of a 5-minute warm-up period at 50% of maximum heart rate, a 25-minute moderate-intensity training period at 65-70% of maximum heart rate, and a 5-minute cool-down period at 50% of maximum heart rate.

  Other: Moderate Intensity Continuous Group

• No intervention
  Control Group

  No intervention will be performed; exercise recommendations will be provided only during routine control.

Interventions

• OtherHigh-Intensity Interval Aerobic Exercise Group

  High-intensity interval lower-extremity aerobic exercise training will be performed on a cycle ergometer for a total duration of 35 minutes. The exercise protocol will consist of a 5-minute warm-up period at 50% of maximum heart rate, a 4 × 4-minute high-intensity training period at 80-95% of maximum heart rate, a 3 × 3-minute active recovery period at 70% of maximum heart rate, and a 5-minute cool-down period at 50% of maximum heart rate.

• OtherModerate Intensity Continuous Group

  Moderate-intensity continuous lower-extremity aerobic exercise training will be performed on a cycle ergometer for a total duration of 35 minutes. The exercise protocol will consist of a 5-minute warm-up period at 50% of maximum heart rate, a 25-minute moderate-intensity training period at 65-70% of maximum heart rate, and a 5-minute cool-down period at 50% of maximum heart rate.

Primary outcomes

1. Functional capacity

   Functional capacity will be assessed using symptom-limited maximal cardiopulmonary exercise testing (CPET), which is considered the gold-standard method for evaluating exercise capacity. CPET will be performed on a cycle ergometer (Corival CPET, Lode, Groningen, the Netherlands).

   Time frame: Baseline and after treatment (6 weeks)

2. Handgrip strength

   Hand grip strength will be assessed using a hydraulic hand dynamometer (Baseline Hydraulic Hand Dynamometer, Model 12-0240, Fabrication Enterprises Inc., White Plains, NY, USA). Measurements will be performed in a seated position with the shoulder adducted, the elbow flexed at 90°, and the forearm in a neutral position. Three measurements will be performed for each hand (right and left), and the highest value obtained from each side will be recorded for statistical analysis.

   Time frame: Baseline and after treatment (6 weeks)

3. Health-related quality of life

   Quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36). The SF-36 is a patient-centered, general health assessment instrument designed to evaluate an individual's overall perception of health and quality of life. It consists of 36 items covering eight domains: physical functioning, role limitations due to physical health problems, role limitations due to emotional problems, vitality, social functioning, bodily pain, general health perceptions, and mental health. The questionnaire includes 11 questions, and each domain is scored on a scale ranging from 0 to 100. Higher scores indicate better perceived health and quality of life.

   Time frame: Baseline and after treatment (6 weeks)

Secondary outcomes

1. Fatigue

   Fatigue will be assessed using the Fatigue Severity Scale (FSS). The FSS is a 9-item scale designed to assess the severity of fatigue and its impact on daily activities and lifestyle in individuals with various health conditions. Each item is rated on a 7-point scale ranging from 1 (strongly disagree) to 7 (strongly agree). The total score ranges from 9 to 63, with higher scores indicating greater fatigue severity.

   Time frame: Baseline and after treatment (6 weeks)

2. Anxiety and Depression

   Anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADS). The HADS is a self-administered instrument developed to identify the risk and severity of anxiety and depression and to assess changes in symptom severity among patients with physical illnesses and individuals attending primary healthcare services. The scale consists of 14 items divided into two subscales: anxiety (HADS-A) and depression (HADS-D), with 7 items in each subscale. Each subscale is scored from 0 to 21, with higher scores indicating greater severity of anxiety or depression. Cut-off scores of ≥10 for the anxiety subscale and ≥7 for the depression subscale have been established to indicate clinically relevant symptoms.

   Time frame: Baseline and after treatment (6 weeks)