Effects of Aerobic Exercise on Ultrasonographic Parameters, Functional Status, Balance, and Quality of Life in Patients With Lower Extremity Lymphedema
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- Kinesiophobia
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Kinesiophobia
时间窗: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)
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.
musculoskeletal ultrasonography- Muscle and Subcutaneous Tissue Thickness
时间窗: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)
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.
musculoskeletal ultrasonography- Subcutaneous Tissue Echogenicity
时间窗: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)
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.
Balance
时间窗: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)
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.
functional mobility
时间窗: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)
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.
Lower limb functional status
时间窗: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)
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.
次要结局
- 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))
研究者
Sinem Akselim
Principle investigator
Bursa Yuksek Ihtisas Training and Research Hospital