Aerobic Training in Lower Extremity Lymphedema

NCT07414615 | Completed

• 1 other identifier: 24.05.2025-194647
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Lymphedema; Lymphedema Lower Extremity

Keywords

Lymphedema; Lower Extremity; Gait; Postural Control; Muscle Strength; Functionality

Outcome Measures

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.

  Baseline and Week 6 (end of intervention)

Secondary Outcomes (9)

• Gait Function-Walking Speed (m/s)

  Baseline and Week 6 (end of intervention)

• Gait Function-Step Length (cm)

  Baseline and Week 6 (end of intervention)

• Gait Function-Double Support Time (%)

  Baseline and Week 6 (end of intervention)

• Gait Function-Cadence (steps/min)

  Baseline and Week 6 (end of intervention)

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

  Baseline and Week 6 (end of intervention)

Study Arms (2)

Complex Decongestive Physiotherapy (CDP)

EXPERIMENTAL

Participants will receive Complex Decongestive Physiotherapy (CDP) according to the standard clinical protocol.

Other: Complex Decongestive Physiotherapy (CDP)

CDP + Aerobic Exercise

EXPERIMENTAL

Participants will receive Complex Decongestive Physiotherapy combined with a structured aerobic exercise program.

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

Interventions

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.

CDP + Aerobic Exercise; Complex Decongestive Physiotherapy (CDP)

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).

CDP + Aerobic Exercise

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakif University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 17, 2026
• Study Start: February 16, 2026
• Primary Completion: April 10, 2026
• Study Completion: May 10, 2026
• Last Updated: July 13, 2026

Record last verified: 2026-02

Locations

TU (1)