Aerobic Exercise Effects in Lower Extremity Lymphedema

NCT07726277 | Not Yet Recruiting

• 1 other identifier: 2024-TBEK-2025/12-15
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Lower extremity lymphedema negatively affects patients' functional status, quality of life, and activities of daily living. Complete decongestive therapy (CDT) is considered the gold-standard conservative treatment for patients with lymphedema. CDT consists of manual lymph drainage (MLD), skin care, compression bandaging, and exercise. Several studies have demonstrated the effectiveness of CDT in patients with lower extremity lymphedema. However, the results of studies investigating the effectiveness of different types of exercise are inconsistent. Moreover, most of these studies have been conducted in patients with upper extremity lymphedema, and the outcome measures have generally been limited to limb circumference measurements and quality of life assessments. To the best of our knowledge, no previous study has comprehensively evaluated the effects of aerobic exercise on both ultrasonographic parameters (quantitative data) and functional outcomes in patients with lower extremity lymphedema, as planned in the present study. Therefore, this study was designed to contribute to the existing literature by investigating these effects.

Conditions

Lower Extremity Lymphedema

Outcome Measures

Primary Outcomes (6)

• Kinesiophobia

  Kinesiophobia will be assessed using the validated Turkish version of the Tampa Scale for Kinesiophobia (TSK), a 17-item questionnaire with a total score ranging from 17 to 68. Change in score from baseline to post-treatment will be evaluated. Higher scores indicate greater kinesiophobia.

  baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)

• musculoskeletal ultrasonography- Muscle and Subcutaneous Tissue Thickness

  All ultrasonographic measurements will be performed by the same experienced examiner under standardized conditions and will be assessed using B-mode ultrasonography. Quadriceps muscle thickness and subcutaneous tissue thickness will be assessed at standardized anatomical landmarks of the anterior thigh. Subcutaneous tissue thickness will be assessed at standardized anatomical sites of the lower limb. Measurements will be recorded in millimeters (mm). Greater thickness indicates increased muscle mass or subcutaneous tissue thickness, respectively. Change in muscle thickness from baseline to post-treatment will be evaluated.

  baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)

• musculoskeletal ultrasonography- Subcutaneous Tissue Echogenicity

  Subcutaneous tissue echogenicity will be assessed by analyzing grayscale intensity values within a defined region of interest using B-mode ultrasonography. Echogenicity will be quantified in grayscale values (arbitrary units). Higher values indicate increased echogenicity.

  baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)

• Balance

  Balance performance will be assessed using the Berg Balance Scale (BBS), a 14-item performance-based measure with a total score ranging from 0 to 56. Each item is scored on a 5-point scale (0-4), with higher scores indicating better balance. Change in score from baseline to post-treatment will be evaluated.

  baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)

• functional mobility

  Functional mobility will be assessed using the Timed Up and Go (TUG) test, which measures the time (in seconds) required to stand up from a chair, walk 3 meters, turn, return, and sit down. Change in time from baseline to post-treatment will be evaluated. Higher times indicate poorer functional mobility.

  baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)

• Lower limb functional status

  Lower limb functional status will be assessed using the Lower Limb Functional Index (LLFI), a 25-item patient-reported outcome measure with a total score ranging from 0 to 100. Scores are typically expressed as a percentage, with higher scores indicating better functional status. Change in score from baseline to post-treatment will be evaluated.

  baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)

Secondary Outcomes (3)

• fatigue

  baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)

• depression

  baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)

• health related quality of life

  baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)

Other Outcomes (1)

• functional capacity

  baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)

Study Arms (2)

control group

ACTIVE COMPARATOR

participants receive standart complete decongestive therapy including manuel lymph drainage,compression therapy, skin care and exercises

Other: complet decongestive therapy

exercise group

EXPERIMENTAL

participants receive complete decongestive therapy combined with an aerobic exercise program

Behavioral: aerobic exercise program; Other: complet decongestive therapy

Interventions

aerobic exercise program BEHAVIORAL

Aerobic exercise using a recumbent cycle ergometer for 20-30 minutes. The exercise intensity will be set to reach 40-60% of the maximum target heart rate reserve. The treatment program will be administered for approximately 1 hour per day, 5 days per week, for a total of 4 weeks (20 sessions).

exercise group

complet decongestive therapy OTHER

manuel lymph drainage, skin care, joint rom exercises, compression

control group; exercise group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of lower extremity lymphedema (unilateral or bilateral)
• Age ≥18 years
• Absence of cognitive impairment
• Provision of written informed consent to participate in the study

You may not qualify if:

• Cognitive impairment
• Presence of general contraindications to exercise (e.g., hemodynamic instability, uncontrolled hypertension, decompensated heart failure, recent myocardial infarction, or unstable angina pectoris)
• Presence of neurological diseases affecting the lower extremities that would preclude participation in the exercise program
• Presence of unhealed fractures in the lower extremities preventing exercise therapy
• Active systemic infection or local infection in the treatment area, such as cellulitis, erysipelas, or thrombophlebitis in the lower extremities
• Acute venous thromboembolic events involving the lower extremities
• Heart failure or renal failure that may cause lower extremity edema
• Presence of concomitant lipedema
• Presence of venous insufficiency
• Ongoing chemotherapy or radiotherapy (among patients with malignancy-related lymphedema)
• Pregnancy

Sponsors & Collaborators

• Bursa Yuksek Ihtisas Training and Research Hospital: lead

Central Study Contacts

Sinem Akselim

CONTACT

+905336391332; sinemakselim@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: July 24, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): March 15, 2027
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share