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Completed

NCT Number: NCT07414615

Aerobic Training in Lower Extremity Lymphedema

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).

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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bezmialem Vakif University

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Complex decongestive physiotherapy (CDP)

Other

Participants will receive Complex Decongestive Physiotherapy five days per week for six weeks, including manual lymphatic drainage, compression bandaging, skin care, and therapeutic exercises.

The exercise program will consist of diaphragmatic breathing exercises, hip flexion-extension, hip abduction-adduction, knee flexion-extension (heel slides), ankle pumps, ankle circumduction, isometric quadriceps contractions, and isometric hip adduction.

All exercises will be performed in a slow and controlled manner under the supervision of a physiotherapist while compression bandaging is applied. Each exercise will be performed for 10 repetitions in one set during each treatment session.

Aerobic training

Other

Participants will complete 20 minutes of aerobic training on a recumbent cycle ergometer. Training intensity will be prescribed at 40-59% of heart rate reserve, calculated using the Karvonen method. Each aerobic training session will conclude with a 5-minute cool-down period on the cycle ergometer at low intensity (≤40% of heart rate reserve).

Primary outcomes

  1. Outcome Measure: Lower Extremity Circumference (cm)

    Time frame: Baseline and Week 6 (end of intervention)

    Lower extremity edema will be assessed using circumferential measurements obtained at 5-cm intervals from the medial malleolus to the inguinal region using a non-elastic measuring tape. Measurements will be performed in the supine position after a standardized rest period. The same evaluator will perform all measurements to ensure consistency. Mean limb circumference (cm) will be calculated to evaluate changes over time.

Secondary outcomes

  1. Gait Function-Walking Speed (m/s)

    Time frame: Baseline and Week 6 (end of intervention)

    Walking speed, expressed in meters per second (m/s), will be assessed using calibrated two-dimensional spatiotemporal gait analysis with Kinovea motion analysis software. Calibration will be performed using a known reference distance prior to analysis. Participants will walk over a predetermined distance at a cadence standardized between 80-90 beats per minute using a metronome. Video recordings will be obtained from sagittal and frontal planes with reflective markers placed on predefined anatomical landmarks to improve measurement accuracy.

  2. Gait Function-Step Length (cm)

    Time frame: Baseline and Week 6 (end of intervention)

    Step length, expressed in centimeters (cm), will be assessed using calibrated two-dimensional spatiotemporal gait analysis with Kinovea software under the standardized walking conditions described above.

  3. Gait Function-Double Support Time (%)

    Time frame: Baseline and Week 6 (end of intervention)

    Double support time, expressed as a percentage (%) of the gait cycle, will be assessed using calibrated two-dimensional spatiotemporal gait analysis with Kinovea software under standardized walking conditions.

  4. Gait Function-Cadence (steps/min)

    Time frame: Baseline and Week 6 (end of intervention)

    Cadence, expressed in steps per minute (steps/min), will be assessed using calibrated two-dimensional spatiotemporal gait analysis with Kinovea software under standardized walking conditions.

  5. Postural Control - Static (Balance Errors Scoring System Total Score)

    Time frame: Baseline and Week 6 (end of intervention)

    Static postural control will be assessed using the Balance Error Scoring System (BESS). Participants will perform three stance conditions (double-leg stance, single-leg stance, and tandem stance) on a firm and foam surfaces. Each stance will be maintained for 20 seconds with eyes closed and hands placed on the iliac crests. Balance errors, including stepping, opening the eyes, lifting hands from the hips, stumbling, or remaining out of position for more than five seconds, will be recorded.

    The total BESS score will be calculated by summing the number of errors across all stance conditions. The total score will be expressed as the number of errors, with lower scores indicating better postural control and higher scores indicating poorer postural control. BESS total score ranges from 0 to 60 errors, with higher scores indicating worse static postural control and lower scores indicating better postural control.

  6. Postural Control - Dynamic (Timed Up and Go Test)

    Time frame: Baseline and Week 6 (end of intervention)

    Dynamic postural control will be assessed using the Timed Up and Go (TUG) test, a valid and reliable measure of functional mobility and balance. Participants will be instructed to rise from a standard chair, walk a distance of 3 meters at a safe and comfortable pace, turn around, walk back to the chair, and sit down.

    The time required to complete the task will be recorded in seconds (s) using a stopwatch. TUG performance will be expressed as completion time in seconds, with shorter times indicating better dynamic postural control and longer times indicating poorer performance.

  7. Lower Extremity Muscle Strength (Manuel Muscle Testing Total Score)

    Time frame: Baseline and Week 6 (end of intervention)

    Lower extremity muscle strength will be assessed using Manual Muscle Testing (MMT), a standardized clinical method for evaluating muscle strength. The following muscle groups will be evaluated bilaterally: hip flexors, hip extensors, hip abductors, hip adductors, knee extensors, knee flexors, and ankle dorsiflexors and plantarflexors.

    Each muscle group will be tested in standardized positions against gravity and manual resistance applied by the physiotherapist. Muscle strength will be graded using the standard 0-5 MMT scale, where 0 indicates no visible or palpable muscle contraction and 5 indicates normal muscle strength against maximal resistance.

    An overall lower extremity muscle strength score will be calculated as the mean of the tested muscle groups. Scores will range from 0 to 5, with higher scores indicating greater muscle strength and lower scores indicating reduced muscle strength.

  8. Lower Extremity Endurance (30-Second Sit-to-Stand Test)

    Time frame: Baseline and Week 6 (end of intervention)

    Lower extremity muscular endurance will be assessed using the 30-Second Sit-to-Stand Test, a valid and reliable measure of functional lower limb endurance. Participants will be instructed to rise to a full standing position and return to a seated position as many times as possible within 30 seconds, with their arms crossed over the chest.

    The total number of correctly completed repetitions within 30 seconds will be recorded. Performance will be expressed as the number of repetitions completed in 30 seconds, with higher values indicating greater lower extremity muscular endurance and lower values indicating reduced endurance.

  9. Lower Extremity Functional Status (LEFS Total Score)

    Time frame: Baseline and Week 6 (end of intervention)

    Lower extremity functional status will be assessed using the Lower Extremity Functional Scale (LEFS), a validated patient-reported outcome measure. The LEFS is a self-administered questionnaire consisting of 20 items designed to evaluate an individual's ability to perform everyday functional activities.

    Each item is scored on a 5-point Likert scale ranging from 0 (extreme difficulty or unable to perform the activity) to 4 (no difficulty). The total LEFS score will be calculated by summing all item scores, resulting in a total score ranging from 0 to 80.

    Scores will be expressed as the total LEFS score (0-80), with higher scores indicating better lower extremity functional status and lower scores indicating greater functional limitation. Participants will complete the questionnaire under the supervision of a physiotherapist to ensure completeness.

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

The Effect of Aerobic Training on Gait, Postural Control, Lower Extremity Muscle Strength and Functionality in Patients With Lower Extremity Lymphedema

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 17, 2026
Registry last updated
Jul 13, 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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