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NCT Number: NCT07726277

Aerobic Exercise Effects in Lower Extremity Lymphedema

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Kinesiophobia

    Time frame: 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.

  2. musculoskeletal ultrasonography- Muscle and Subcutaneous Tissue Thickness

    Time frame: 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.

  3. musculoskeletal ultrasonography- Subcutaneous Tissue Echogenicity

    Time frame: 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.

  4. Balance

    Time frame: 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.

  5. functional mobility

    Time frame: 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.

  6. Lower limb functional status

    Time frame: 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 outcomes

  1. fatigue

    Time frame: 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.

  2. depression

    Time frame: 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.

  3. health related quality of life

    Time frame: 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.

Other outcomes

  1. functional capacity

    Time frame: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sinem Akselim

CONTACT

[email protected]

+905336391332

Sponsors and collaborators

Lead sponsor

Bursa Yuksek Ihtisas Training and Research Hospital

Other Gov

Registry information

Official study title

Effects of Aerobic Exercise on Ultrasonographic Parameters, Functional Status, Balance, and Quality of Life in Patients With Lower Extremity Lymphedema

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jul 24, 2026
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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