Aerobic Exercise Effects in Lower Extremity Lymphedema

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBursa Yuksek Ihtisas Training and Research Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • aerobic exercise program

    Behavioral

    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).

  • complet decongestive therapy

    Other intervention

    manuel lymph drainage, skin care, joint rom exercises, compression

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: control groupActive comparator 1 intervention
Group B: exercise groupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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)
2

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)
3

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)
4

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)

Secondary outcomes

1

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)
2

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)
3

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)

Other outcomes

1

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)

Locations

This trial has no locations.

Sponsors and contacts

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