Evaluation of Disease Severity, Respiratory Muscle Strength, Respiratory Functions, Functionality, and Quality of Life in Patients With Upper Limb Lymphedema
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- MIP and MEP value
研究概览
简要总结
The aim of our study is to assess disease severity, respiratory muscle strength, respiratory functions, pectoralis minor muscle shortening, functionality, and quality of life (QoL) in patients with upper limb lymphedema (ULL), and to compare these findings with healthy controls.The disease severity was assessed using the Stillwell classification system; respiratory muscle strength was measured through maximum inspiratory and expiratory intraoral pressures (MIP, MEP, respectively); respiratory functions were evaluated with a spirometer; pectoralis minor muscle shortening was measured with a tape measure; functionality was assessed using the Disabilities of the Arm, Shoulder and Hand (DASH); and QoL was evaluated with the Lymphedema Quality of Life Questionnaire - Arm (LYMQOL-Arm).
详细描述
The study had a cross-sectional observational study design. The participants were divided into two groups, patients with ULL in Group 1; the healthy individuals were included in Group 2. All assessments for both groups were performed by two different physiotherapists.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •aged 25-65 years with secondary, unilateral upper limb lymphedema in Phase 2 of the protection stage,
- •wearing compression garments,
- •who have not received manual lymph drainage (MLD) therapy in the last 3 months
- •along with healthy controls of a similar age who volunteered to participate.
排除标准
- •being in Phase 1 of lymphedema treatment (the edema-reducing phase),
- •being classified as NYHA Class III and/or IV according to the New York Heart Association classification system,
- •having a chronic respiratory disease,
- •presence of active infection (such as lymphangitis or cellulitis), or undergoing radiotherapy/chemotherapy due to breast cancer.
结局指标
主要结局
MIP and MEP value
时间窗: 9 months
assessments include maximal inspiratory intraoral pressure (MIP) and expiratory intraoral pressure (MEP).
DASH questionnaire
时间窗: 9 months
Disabilities of the Arm, Shoulder and Hand (DASH) is used for upper extremity functions. Questionnaire score ranged between 0-100. A higher total score indicates decreased functionality.
LYMQOL-Arm questionnaire
时间窗: 9 months
Lymphedema Quality of Life Questionnaire - Arm is used for assess disease related quality of life.The high scores are indicative of poorer QoL. Questionnaire score ranged between 0-100.
FVC
时间窗: 9 months
FVC is used for forced vital capacity which measure by spirometer
pectoralis minor muscle length
时间窗: 9 months
pectoralis minor muscle length is used for pectoralis muscle shortness
次要结局
未报告次要终点
研究者
Gamze Aydin
Researcher, PhD
Istanbul University - Cerrahpasa (IUC)