An interventional study of aerobic exercise program and complet decongestive therapy in Lower Extremity Lymphedema, sponsored by Bursa Yuksek Ihtisas Training and Research Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-24.
Sponsored by Bursa Yuksek Ihtisas Training and Research Hospital · Not applicable, Interventional, and Treatment
Lower extremity lymphedema negatively affects patients' functional status, quality of life, and activities of daily living. Complete decongestive therapy (CDT) is considered the gold-standard conservative treatment for patients with lymphedema. CDT consists of manual lymph drainage (MLD), skin care, compression bandaging, and exercise. Several studies have demonstrated the effectiveness of CDT in patients with lower extremity lymphedema. However, the results of studies investigating the effectiveness of different types of exercise are inconsistent. Moreover, most of these studies have been conducted in patients with upper extremity lymphedema, and the outcome measures have generally been limited to limb circumference measurements and quality of life assessments.
To the best of our knowledge, no previous study has comprehensively evaluated the effects of aerobic exercise on both ultrasonographic parameters (quantitative data) and functional outcomes in patients with lower extremity lymphedema, as planned in the present study. Therefore, this study was designed to contribute to the existing literature by investigating these effects.
Bursa Yuksek Ihtisas Training and Research Hospital is the lead sponsor of 46 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
participants receive standart complete decongestive therapy including manuel lymph drainage,compression therapy, skin care and exercises
Other: complet decongestive therapy
participants receive complete decongestive therapy combined with an aerobic exercise program
Behavioral: aerobic exercise program · Other: complet decongestive therapy
Aerobic exercise using a recumbent cycle ergometer for 20-30 minutes. The exercise intensity will be set to reach 40-60% of the maximum target heart rate reserve. The treatment program will be administered for approximately 1 hour per day, 5 days per week, for a total of 4 weeks (20 sessions).
manuel lymph drainage, skin care, joint rom exercises, compression
Kinesiophobia
Kinesiophobia will be assessed using the validated Turkish version of the Tampa Scale for Kinesiophobia (TSK), a 17-item questionnaire with a total score ranging from 17 to 68. Change in score from baseline to post-treatment will be evaluated. Higher scores indicate greater kinesiophobia.
Time frame: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)
musculoskeletal ultrasonography- Muscle and Subcutaneous Tissue Thickness
All ultrasonographic measurements will be performed by the same experienced examiner under standardized conditions and will be assessed using B-mode ultrasonography. Quadriceps muscle thickness and subcutaneous tissue thickness will be assessed at standardized anatomical landmarks of the anterior thigh. Subcutaneous tissue thickness will be assessed at standardized anatomical sites of the lower limb. Measurements will be recorded in millimeters (mm). Greater thickness indicates increased muscle mass or subcutaneous tissue thickness, respectively. Change in muscle thickness from baseline to post-treatment will be evaluated.
Time frame: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)
musculoskeletal ultrasonography- Subcutaneous Tissue Echogenicity
Subcutaneous tissue echogenicity will be assessed by analyzing grayscale intensity values within a defined region of interest using B-mode ultrasonography. Echogenicity will be quantified in grayscale values (arbitrary units). Higher values indicate increased echogenicity.
Time frame: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)
Balance
Balance performance will be assessed using the Berg Balance Scale (BBS), a 14-item performance-based measure with a total score ranging from 0 to 56. Each item is scored on a 5-point scale (0-4), with higher scores indicating better balance. Change in score from baseline to post-treatment will be evaluated.
Time frame: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)
functional mobility
Functional mobility will be assessed using the Timed Up and Go (TUG) test, which measures the time (in seconds) required to stand up from a chair, walk 3 meters, turn, return, and sit down. Change in time from baseline to post-treatment will be evaluated. Higher times indicate poorer functional mobility.
Time frame: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)
Lower limb functional status
Lower limb functional status will be assessed using the Lower Limb Functional Index (LLFI), a 25-item patient-reported outcome measure with a total score ranging from 0 to 100. Scores are typically expressed as a percentage, with higher scores indicating better functional status. Change in score from baseline to post-treatment will be evaluated.
Time frame: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)
fatigue
Fatigue severity will be assessed using the Fatigue Severity Scale (FSS), a 9-item self-reported questionnaire with each item scored from 1 to 7. The total score is calculated as the mean of the items, ranging from 1 to 7, with higher scores indicating greater fatigue severity. Change in score from baseline to post-treatment will be evaluated.
Time frame: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)
depression
Depression will be assessed using the Beck Depression Inventory (BDI), a 21-item self-reported questionnaire with a total score ranging from 0 to 63. Higher scores indicate more severe depressive symptoms. Change in score from baseline to post-treatment will be evaluated.
Time frame: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)
health related quality of life
Lymphedema-related quality of life will be assessed using the Lymphedema Quality of Life Questionnaire (LYMQOL), a disease-specific patient-reported outcome measure including domains such as function, appearance, symptoms, and mood. Domain scores and overall score range from 0 to 10, with higher scores indicating worse quality of life. Change in scores from baseline to post-treatment will be evaluated.
Time frame: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)
functional capacity
Functional exercise capacity will be assessed using the 6-Minute Walk Test (6MWT), which measures the distance walked in meters over 6 minutes. Change in distance from baseline to post-treatment will be evaluated. Greater distances indicate better functional performance.
Time frame: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)
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Plan to share: No
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Bursa Yuksek Ihtisas Training and Research Hospital