Aerobic Training in Lower Extremity Lymphedema
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-60
SponsorBezmialem Vakif University
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Complex Decongestive Physiotherapy (CDP)
Other interventionParticipants 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 interventionParticipants 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).
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Complex Decongestive Physiotherapy (CDP)Experimental treatment 1 intervention
Group B: CDP + Aerobic ExerciseExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and Week 6 (end of intervention)Secondary outcomes
1
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.
Time frame
Baseline and Week 6 (end of intervention)2
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.
Time frame
Baseline and Week 6 (end of intervention)3
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.
Time frame
Baseline and Week 6 (end of intervention)4
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.
Time frame
Baseline and Week 6 (end of intervention)Sponsors and contacts
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Source ClinicalTrials.gov