Lower Extremity Lymphedema
Conditions
Brief summary
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.
Interventions
BEHAVIORALaerobic exercise program
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).
OTHERcomplet decongestive therapy
manuel lymph drainage, skin care, joint rom exercises, compression
Sponsors
Bursa Yuksek Ihtisas Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of lower extremity lymphedema (unilateral or bilateral) * Age ≥18 years * Absence of cognitive impairment * Provision of written informed consent to participate in the study
Exclusion criteria
* Cognitive impairment * Presence of general contraindications to exercise (e.g., hemodynamic instability, uncontrolled hypertension, decompensated heart failure, recent myocardial infarction, or unstable angina pectoris) * Presence of neurological diseases affecting the lower extremities that would preclude participation in the exercise program * Presence of unhealed fractures in the lower extremities preventing exercise therapy * Active systemic infection or local infection in the treatment area, such as cellulitis, erysipelas, or thrombophlebitis in the lower extremities * Acute venous thromboembolic events involving the lower extremities * Heart failure or renal failure that may cause lower extremity edema * Presence of concomitant lipedema * Presence of venous insufficiency * Ongoing chemotherapy or radiotherapy (among patients with malignancy-related lymphedema) * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Kinesiophobia | baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks) | 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. |
| musculoskeletal ultrasonography- Muscle and Subcutaneous Tissue Thickness | baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks) | 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. |
| musculoskeletal ultrasonography- Subcutaneous Tissue Echogenicity | baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks) | 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. |
| Balance | baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks) | 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. |
| functional mobility | baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks) | 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. |
| Lower limb functional status | baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| fatigue | baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks) | 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. |
| depression | baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks) | 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. |
| health related quality of life | baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks) | 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. |
Contacts
CONTACTSinem Akselim
Outcome results
None listed