Aerobic Exercise Effects in Lower Extremity Lymphedema
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: aerobic exercise program, complet decongestive therapy.
- Who it may be relevant to
- Registry conditions: Lower Extremity Lymphedema. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effects of Aerobic Exercise on Ultrasonographic Parameters, Functional Status, Balance, and Quality of Life in Patients With Lower Extremity Lymphedema
Overview
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
- Behavioral aerobic 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). - Other complet decongestive therapy
manuel lymph drainage, skin care, joint rom exercises, compression
Primary outcome measures
- 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 [Time frame: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)]
- musculoskeletal ultrasonography- Subcutaneous Tissue Echogenicity [Time frame: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)]
- Balance [Time frame: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)]
- functional mobility [Time frame: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)]
- Lower limb functional status [Time frame: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)]
Secondary outcome measures (3)
- fatigue [Time frame: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)]
- depression [Time frame: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)]
- health related quality of life [Time frame: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07726277 · 2024-TBEK-2025/12-15