Effects of Hospital-Based Aerobic Exercise Therapy on Exercise Capacity, Body Composition, Functional Level and Quality of Life in Patients With Primary Lower Extremity Lymphedema; Prospective Randomized Controlled Single Blind Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- 30-second sit-stand test (30-s chair-stand test, 30s-CST)
研究概览
简要总结
Our aim in this study is to evaluate the effects of lymphedema on exercise capacity, body composition, functional level and quality of life in lymphedema patients with primary lower extremity involvement.
详细描述
Male and female patients aged 18-65, who applied to Kayseri City Hospital's Department of Physical Medicine and Rehabilitation (PMR), lymphedema outpatient clinic between September 2023 and September 2024 due to lower extremity edema, will be included in this study. Lymphedema was diagnosed by clinical and/or imaging methods (lower extremity circumference difference measurements, venous Doppler ultrasonography, lymphoscintigraphy), evaluated by an PMR specialist physician, phase 1 decongestive treatment was applied within the last month, stage 2-3 lower legs using Class 3 compression stockings were used. Patients with extremity lymphedema will be included. Our study is a prospective, randomized controlled, single-blind clinical trial. In our study, survey forms will be filled out by a researcher who is blind to the applied tests and study groups. Patients will be divided into 2 groups according to computerized randomization.
Demographic data such as age, gender, occupational status, education level, marital status of the patients whose verbal and written consent was obtained; Height, body weight, body mass index, smoking-alcohol use, medications used and additional diseases will be questioned and recorded in their files.
The lower extremity circumference of the patients will be measured with a flexible standard tape measure that is 150 cm long, 1 cm wide and spaced one cm apart. Measurements will be marked including the metatarsophalangeal joint, the middle of the dorsum of the foot, the ankle, and the end of the thigh at 4 cm intervals from this area. Circumference measurement from the marked points will be repeated twice each time by a physiatrist blinded to the study, and the average of the two measurements will be taken. These measurements will be repeated at the beginning of the study and at weeks 4 and 16.
The total extremity volume will be determined by calculating the data obtained from the circumference measurement with the Frustum formula, which is used to indirectly determine the extremity volume. The difference between both lower extremities before and after treatment will be determined. These evaluations will be repeated at the beginning of the study and at weeks 4 and 16.
The body extracellular fluid ratio will be determined by the bioelectrical impedance method using a body composition analyzer in which the impedance in the tissues is analyzed by applying a low level of electric current to the body. This measurement will be repeated at the beginning of the study and at weeks 4 and 16.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have completed complete decongestive therapy (CBT) Phase 1 treatment within the last 1 month, use Class 3 compression garments, and are scheduled for CBT Phase 2 treatment.
- •Patients with stage 2-3 unilateral or bilateral primary lymphedema with lower extremity involvement
- •Women and men aged 18-65
- •Patients who agreed to participate in the study and received written voluntary consent form.
排除标准
- •Patients who do not agree to participate in the study
- •Patients without cooperation and compliance
- •Presence of phlebo edema, lipedema, cellulitis, lymphocele
- •History of lower extremity venous system disease
- •Presence of acute infection
- •History of malignancy
- •Presence of acute/chronic lung disease (history of acute pulmonary embolism, acute bronchial asthma attack, chronic interstitial lung disease)
- •Chronic liver failure
- •Renal dysfunction
- •Uncontrolled hypertension and diabetes mellitus
- •Presence of orthopedic disease that may prevent walking (joint limitation, ankylosis, amputation)
- •Use of medications known to affect physical performance, heart rate or metabolism (including Beta blockers)
- •Patients who have been included in the CPR (Cardiopulmonary resuscitation) program in the last year
结局指标
主要结局
30-second sit-stand test (30-s chair-stand test, 30s-CST)
时间窗: week 0, 4th week, 16th week
It is a test with proven validity and reliability that evaluates the patient's sit-to-stand activity, lower extremity strength and dynamic balance. The patient's sitting height is approximately 43 cm on a chair without arms; The patient is asked to sit with his back straight and straight, his arms crossed in front, his feet on the floor, and then he is asked to sit and stand within 30 seconds. The number of times he sits and stands gives the score of the test.
次要结局
- Bioimpedance measurement(week 0, 4th week, 16th week)
- Lower Extremity Functional Scale (LEFS)(week 0, 4th week, 16th week)
- Lymphedema Life Impact Scale (LLIC)(week 0, 4th week, 16th week)
- Cardiopulmonary exercise test (CPET)(week 0, 4th week, 16th week)
- 6-minute walk test (6MWT)(week 0, 4th week, 16th week)
- Circumference and volume measurement(week 0, 4th week, 16th week)
- Hospital Anxiety and Depression Scale (HADS)(week 0, 4th week, 16th week)
- Numerical Rating Scale (NRS)(week 0, 4th week, 16th week)
研究者
Havva Talay Çalış
professor doctor
Kayseri City Hospital