Effects of Inspiratory Muscle Training on Lymphedema Volume, Subcutaneous Tissue Thickness, Upper Extremity Functioning, Sleep Quality, and Quality of Life in Upper Extremity Lymphedema Treatment: a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Volumetric Measurement
研究概览
简要总结
The aim of this study is to examine the effect of inspiratory muscle training on lymphedema volume, subcutaneous tissue thickness, upper extremity functionality and sleep quality in the treatment of upper extremity lymphedema. Two groups included 24 patients with lymphedema will be divided into gropus (intervetion and control) and they will compare each other.
详细描述
All patients will be treated 5 days a week, 4 weeks, with each session lasting 45-60 minutes. While only decongestive treatment will be applied to the control group, inspiratory muscle training will be given to the interventional group in addition to decongestive treatment. Evaluations of the patients will be made before and after of 4-week treatment program.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Having been diagnosed with lymphedema in the upper extremity at least 6 months ago
- •Having stage 2 lymphedema
- •Having a 2-8 cm circumference difference between the affected extremity and the healthy extremity at any reference point
- •Being between the ages of 18-60
- •Voluntarily agreeing to participate in the study
- •Not having received any lymphedema treatment in the last 6 months.
- •Not having any physical, respiratory, neurological and/or systemic disease that would prevent participation in the treatment program.
排除标准
- •Having stage 1 and stage 3 lymphedema
- •It has been less than 6 months since the diagnosis of lymphedema was made
- •Being under 18 years of age and over 60 years of age
- •Having a circumference measurement difference of more than 8 cm and less than 2 cm at any reference point between the affected extremity and the healthy extremity
- •Lymphedema or elephantiasis with papilloma, hyperkeratosis
- •Uncontrolled hypertension, pulmonary edema, presence of serious cardiovascular disease
- •Presence of active metastasis
- •Acute inflammatory diseases
研究组 & 干预措施
Group 1
Inspiratory muscle training
干预措施: Decongestive treatment (Other)
Group 2
Controls
干预措施: Decongestive treatment (Other)
Group 1
Inspiratory muscle training
干预措施: Inspiratory muscle training (Other)
结局指标
主要结局
Volumetric Measurement
时间窗: baseline and immediately after the intervention (in the 5th week)
to measure volume of the upper extremity in milliliter (increased volume compared to the normal upper extremity- increased score means worse outcome)
Measurement of Subcutaneous Tissue Thickness with Ultrasound (US)
时间窗: baseline and immediately after the intervention (in the 5th week)
to measure thickness of the tissue (increased thickness compared to the normal upper extremity- increased score means worse outcome)
次要结局
- VISUAL ANALOG SCALE-VAS(baseline and immediately after the intervention (in the 5th week))
- Intraoral pressure measure(before and after the intervention (in the 5th week))
- Quick Disabilities Of the Arm,Shoulder And Hand (Quick DASH)(baseline and immediately after the intervention (in the 5th week))
- Lymph-ICF(before and after the intervention (in the 5th week))
- Respiratory Function Test(before and after the intervention (in the 5th week))
- Lymphedema Life Impact Scale - LLIS(before and after the intervention (in the 5th week))
- HAND DYNAMOMETER(baseline and immediately after the intervention (in the 5th week))
- Pittsburgh Sleep Quality Index (PSQI)(before and after the intervention (in the 5th week))
研究者
Ugur Cavlak
CLINICAL PROFESSOR
Biruni University