ClinicalTrials.Veeva

Menu

Aerobic Training in Lower Extremity Lymphedema

B

Bezmialem Vakif University

Status

Enrolling

Conditions

Lymphedema Lower Extremity
Lymphedema

Treatments

Other: Aerobic Training
Other: Complex Decongestive Physiotherapy (CDP)

Study type

Interventional

Funder types

Other

Identifiers

NCT07414615
24.05.2025-194647

Details and patient eligibility

About

This randomized controlled study aims to evaluate the effects of aerobic exercise training on gait, postural control, lower extremity muscle strength, and functional status in individuals with bilateral lower extremity lymphedema. A total of 24 participants aged between 20 and 60 years with a diagnosis of bilateral lower extremity lymphedema will be randomly assigned to either an aerobic exercise group or a control group. The aerobic exercise group will receive aerobic exercise training in addition to Complex Decongestive Therapy (CDT), while the control group will receive CDT alone.

Lower extremity edema will be assessed using circumferential measurements taken from the ankle to the inguinal region. Gait function will be evaluated through angular and spatiotemporal analysis using Kinovea software, including parameters such as step length, walking speed, and double support time. Postural control will be assessed using the Balance Error Scoring System (BESS) and the Timed Up and Go Test. Lower extremity muscle strength and endurance will be evaluated using Manual Muscle Testing and the 30-Second Sit-to-Stand Test. Functional status of the lower extremities will be assessed using the Lower Extremity Functional Scale (LEFS).

Full description

Lymphedema is a chronic and progressive condition characterized by the accumulation of protein-rich interstitial fluid in the subcutaneous tissue. Based on its etiology, lymphedema is classified as either primary or secondary. Primary lymphedema results from abnormal development of the lymphatic system and presents as progressive swelling without an identifiable underlying medical condition; its onset may vary from childhood to adulthood. Secondary lymphedema occurs due to disruption of the lymphatic system caused by factors such as trauma, infection, cancer-related surgery, or radiotherapy.

Lower extremity lymphedema most commonly develops secondary to cancer treatments in developed countries, whereas in developing countries it may also result from parasitic infections such as filariasis. In addition, venous insufficiency, obesity, and lymphatic damage following orthopedic surgeries are recognized contributing factors. Swelling, tissue fibrosis, and increased limb volume lead to both structural and functional alterations in the extremities, particularly affecting the hip, knee, and ankle joints. In individuals with advanced-stage lymphedema, reductions in joint range of motion, muscle strength deficits, and impairments in neuromuscular activation are frequently observed. Alterations in the body's center of gravity occur, and insufficient muscular strength to compensate for these changes results in impaired postural control and an increased risk of falls.

Dunberger et al. reported that lymphedema-related weight gain and pain, when combined with progressively reduced physical activity, lead to decreased muscle strength and negatively affect functional capacity over time. Furthermore, lymphedema has been shown to significantly influence gait function and kinetic-parametric gait characteristics. Increased limb volume in individuals with lymphedema alters mechanical loading within the musculoskeletal system, resulting in impairments in key gait parameters such as walking speed, step length, double support time, and balance control. Gait asymmetry is commonly observed, while increased proprioceptive deficits and pain contribute to impaired motor control.

Physiotherapy and rehabilitation interventions constitute a fundamental component of lymphedema management across all stages of the condition. The primary goals of lower extremity lymphedema treatment are to minimize swelling, prevent complications, and restore limb functionality. Management typically requires lifelong care and may involve conservative, medical, and, in some cases, surgical interventions. The gold standard treatment is Complex Decongestive Physiotherapy (CDP), which includes manual lymphatic drainage, compression bandaging, skin care, and exercise, and is administered by trained physiotherapists.

In a study conducted by Boris et al., an average limb volume reduction of 62.7% was observed following the application of Complex Decongestive Therapy in patients with lower extremity lymphedema. In addition, aerobic training is commonly recommended for individuals with lymphedema. Aerobic conditioning typically involves repetitive movements engaging large muscle groups. Cycle ergometer exercise is a form of aerobic training that enhances venous and lymphatic flow by increasing the muscle pump effect, improving functional capacity, strengthening lower extremity musculature, enhancing cardiovascular endurance, improving tissue oxygenation, and supporting effective weight management.

In a study by Do et al., 40 patients diagnosed with unilateral lymphedema following cervical, endometrial, or ovarian cancer were treated with Complex Decongestive Therapy for four weeks, with additional stretching, strengthening, and aerobic exercise programs. Both treatment groups demonstrated significant reductions in limb volume; however, no statistically significant difference was found between the two intervention approaches.

Enrollment

24 estimated patients

Sex

All

Ages

20 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Aged between 20 and 60 years
  • Diagnosed with bilateral lower extremity lymphedema
  • Completion of chemotherapy, radiotherapy, or other oncological treatments, with no oncological contraindication to participation
  • Signed written informed consent
  • Willingness to participate in the study

Exclusion criteria

  • Presence of uncontrolled cardiac or pulmonary disease
  • Presence of renal insufficiency
  • Presence of musculoskeletal or neurological disorders affecting mobility or balance
  • Presence of systemic or local infection in the lower extremity
  • Impaired independent ambulation or use of assistive walking devices
  • Pregnancy
  • Presence of visual, cognitive, or intellectual impairment that may interfere with participation in assessment or intervention procedures

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

24 participants in 2 patient groups

Complex Decongestive Physiotherapy (CDP)
Experimental group
Description:
Participants will receive Complex Decongestive Physiotherapy (CDP) according to the standard clinical protocol.
Treatment:
Other: Complex Decongestive Physiotherapy (CDP)
CDP + Aerobic Exercise
Experimental group
Description:
Participants will receive Complex Decongestive Physiotherapy combined with a structured aerobic exercise program.
Treatment:
Other: Complex Decongestive Physiotherapy (CDP)
Other: Aerobic Training

Trial contacts and locations

1

Loading...

Central trial contact

Deniz Tuncer, PhD, PT; Serra Undil-Erdogmus, PT

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems