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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Complex Decongestive Physiotherapy (CDP) | Experimental | Participants will receive Complex Decongestive Physiotherapy (CDP) according to the standard clinical protocol. |
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| CDP + Aerobic Exercise | Experimental | Participants will receive Complex Decongestive Physiotherapy combined with a structured aerobic exercise program. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Outcome Measure: Lower Extremity Circumference (cm) | 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. | Baseline and Week 6 (end of intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Gait Function-Walking Speed (m/s) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Deniz Tuncer, PhD, PT | Contact | +902124012600 | 4647 | dtuncer@bezmialem.edu.tr |
| Serra Undil-Erdogmus, PT | Contact | +90 541 214 15 43 | serraundil@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bezmialem Vakif University | Recruiting | Istanbul | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D008209 | Lymphedema |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| 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). |
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| Baseline and Week 6 (end of intervention) |
| Gait Function-Step Length (cm) | 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. | Baseline and Week 6 (end of intervention) |
| Gait Function-Double Support Time (%) | 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. | Baseline and Week 6 (end of intervention) |
| Gait Function-Cadence (steps/min) | 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. | Baseline and Week 6 (end of intervention) |
| Postural Control - Static (Balance Errors Scoring System Total Score) | 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. | Baseline and Week 6 (end of intervention) |
| Postural Control - Dynamic (Timed Up and Go Test) | 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. | Baseline and Week 6 (end of intervention) |
| Lower Extremity Muscle Strength (Manuel Muscle Testing Total Score) | 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. | Baseline and Week 6 (end of intervention) |
| Lower Extremity Endurance (30-Second Sit-to-Stand Test) | 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. | Baseline and Week 6 (end of intervention) |
| Lower Extremity Functional Status (LEFS Total Score) | 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. | Baseline and Week 6 (end of intervention) |