Evaluation of Home Program and Telerehabilitation for the Treatment Process in Patients With Breast Cancer-Related Lymphedema
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Efficacity
研究概览
简要总结
During the Covid-19 pandemic, rehabilitation services for all patients were affected, and a term that was previously in use but gained popularity during the pandemic entered our vocabulary: 'Telerehabilitation'. The purpose of our study is to evaluate the treatment process and adherence of patients undergoing telerehabilitation.
详细描述
Our study is a randomized single-blind prospective study. Patients aged 18 to 75 years with stage 1-2 lymphedema associated with breast cancer and upper extremity lymphedema, who had undergone breast surgery at least 3 months prior, were included in the study. Group 1: Patients were given a brochure explaining the massage and exercises they should perform. They were periodically contacted by a physiotherapist and clinician to remind them of their tasks. Group 2: Patients underwent telerehabilitation exercises and massages three times a week guided by a physiotherapist and clinician, and on the remaining days, they continued their self-administered tasks. Patients were evaluated three times: before treatment, at weeks 5 and 8 after treatment. During each visit, patients' inter-limb volume difference, Quick DASH and Life Impact Scale scores, pain, tension, stiffness, and heaviness sensations were assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients who had undergone breast surgery at least 3 months ago
- •Had stage 1-2 lymphedema
- •Had upper extremity lymphedema associated with breast cancer
排除标准
- •Signs of infection such as lymphangitis, cellulitis, fungal infections
- •Those with documented lymph node metastases
- •Those with bilateral lymphedema
- •Those with other diseases affecting upper extremity functions
- •Those with a history of previous surgery related to the upper extremity
研究组 & 干预措施
Telerehabilitation Group
patients received exercises and massages through TR three times a week, conducted by a physiotherapist and a clinician. They were encouraged to perform their exercises and wear compression garments on the remaining days. Prior to the program, patients or their relatives received training from physiotherapists regarding exercises and Manual Lymphatic Drainage (MLD). Patients or their relatives were informed about the Zoom program and were instructed to acquire the application online. Two physiotherapists and groups of five patients each were organized based on rehabilitation days and hours, and access to the Zoom link was provided.
干预措施: Manuel Lymphatic Drainage(MLD), Exercises (Other)
Home- Exercise Group
patients were provided with a brochure explaining the massages and exercises they needed to perform. Additionally, they were contacted three times a week by a physiotherapist and a clinician to remind them of the treatments, assess the continuity and accuracy of the treatments, encourage them to perform the treatments correctly and consistently, and promote the wearing of compression garments.
干预措施: Manuel Lymphatic Drainage(MLD), Exercises (Other)
结局指标
主要结局
Efficacity
时间窗: Time Frame: 8 weeks
Lymphedema Quality of Life Impact Scale
Symptom Severity
时间窗: Time Frame: 8 weeks
Shoulder pain, tightness, sensation of heaviness, and stiffness were evaluated using a numerical scale (1 to 10 points)
Functionality
时间窗: Time Frame: 8 weeks
Ouick Disabilities of the Arm, Shoulder and Hand (Quick DASH) questionnaire
Volume Measurements
时间窗: Time Frame: 8 weeks
Arm measurement was measured with a tape measure at 4 cm intervals and calculated using the cone method in cm3
Volume Measurements
时间窗: Time Frame: Day 0
Arm measurement was measured with a tape measure at 4 cm intervals and calculated using the cone method in cm3
Volume Measurements
时间窗: Time Frame: 5 weeks
Arm measurement was measured with a tape measure at 4 cm intervals and calculated using the cone method in cm3
Symptom Severity
时间窗: Time Frame: Day 0
Shoulder pain, tightness, sensation of heaviness, and stiffness were evaluated using a numerical scale (1 to 10 points)
Symptom Severity
时间窗: Time Frame: 5 weeks
Shoulder pain, tightness, sensation of heaviness, and stiffness were evaluated using a numerical scale (1 to 10 points)
Functionality
时间窗: Time Frame: Day 0
Ouick Disabilities of the Arm, Shoulder and Hand (Quick DASH) questionnaire
Functionality
时间窗: Time Frame: 5 weeks
Ouick Disabilities of the Arm, Shoulder and Hand (Quick DASH) questionnaire
Efficacity
时间窗: Time Frame: Day 0
Lymphedema Quality of Life Impact Scale
Efficacity
时间窗: Time Frame: 5 weeks
Lymphedema Quality of Life Impact Scale
次要结局
- Patient satisfaction with the treatment(Time Frame: 8 weeks)
- patients were asked to compare their hand functionality to before the injury(Time Frame: 8 weeks)
- Patient satisfaction with the treatment(Time Frame: 5 weeks)
- patients were asked to compare their hand functionality to before the injury(Time Frame: 5 weeks)