Effect of Scapular and Shoulder Muscle Exercises in Preventing Secondary Lymphedema Following Breast Cancer Surgery – A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Arm circumference in centimeters
研究概览
简要总结
This study is a randomized, single blinded, parallel group trial comparing the conventional treatment and scapular and shoulder muscle strengthening exercises in preventing arm lymphoedema among the patients who have undergone breast cancer surgery. The study has been planned to conduct for a duration of 10 months. The outcome measures being arm circumference, arm volumetry, muscle strength, shoulder range of motion, shoulder pain and disability, quality of life using inch tape, volumeter, baseline push pull dynamometer, goniometer, SPADI and FACT B questionnaire. It is expected that strengthening exercises will prevent arm lymphedema.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •1 Modified Radical Mastectomy with ALND 2 Breast conservation surgery with ALND 3 Unilateral surgery 4 Neo adjuvant chemotherapy 5 Adjunct Chemotherapy and radiation following surgery 6 First surgery for invasive Breast cancer 7 Patients under Chief Ministers Comprehensive Health Insurance Scheme will be included for our study 8 Patients who agree to be monitored through video call 9 Willingness of patient to participate in the study.
排除标准
- •1 Platelet count < 75,000/ul 2 Hb level < 8% 3 Cardiac Patients [Cardiovascular instability / cardiovascular symptoms at low workloads(<3 metabolic equivalents [METs])] 4 Impaired cognition 5 Patient unable to understand English or Tamil 6 Marked orthopedic and/or musculoskeletal limitations.
结局指标
主要结局
Arm circumference in centimeters
时间窗: preoperative measurement | Assessment | After 3 weeks | After 6 weeks | After 9 weeks | After 12 weeks | Afafter 20 weeks | 16 weeks
Volumetry in millimeters
时间窗: preoperative measurement | Assessment | After 3 weeks | After 6 weeks | After 9 weeks | After 12 weeks | Afafter 20 weeks | 16 weeks
Muscle strength in kilograms
时间窗: preoperative measurement | Assessment | After 3 weeks | After 6 weeks | After 9 weeks | After 12 weeks | Afafter 20 weeks | 16 weeks
Shoulder range of motion in degrees
时间窗: preoperative measurement | Assessment | After 3 weeks | After 6 weeks | After 9 weeks | After 12 weeks | Afafter 20 weeks | 16 weeks
Shoulder pain and disability index in percentage
时间窗: preoperative measurement | Assessment | After 3 weeks | After 6 weeks | After 9 weeks | After 12 weeks | Afafter 20 weeks | 16 weeks
次要结局
- Quality of life score higher the score greater the quality of life(Baseline preoperative)