A study to assess the effectiveness of exercise protocol on upper arm dysfunction and quality of life among women with breast cancer who have undergone mastectomy with axillary lymph node dissection.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Upper arm dysfunction assessed by Disability of Arm Shoulder and Hand Questionnaire
研究概览
简要总结
This study is a randomized controlled trial to assess the effectiveness of exercise protocol in decreasing upper arm dysfunction and improving quality of life among the women who have undergone mastectomy with axillary lymph node dissection. Breast cancer patients who have undergone mastectomy with axillary lymph node dissection were randomized to experimental and control group.Experimental group received exercise protocol while control group received routine /standard care.Pretest was taken from both groups .Then intervention was started in experimental group.Post test was taken in both groups at 2weeks after surgery and at 8 weeks after surgery.
Objectives of the study are
1.To assess upper arm dysfunction among women with breast cancer who have undergone mastectomy with axillary lymph node dissection.
2.To evaluate the effectiveness of exercise protocol on upper arm dysfunction among women with breast cancer who have undergone mastectomy with axillary lymph node dissection.
3.To evaluate the effectiveness of exercise protocol on quality of life among women with breast cancer who have undergone mastectomy with axillary lymph node dissection.
Hypothesis1-There will be a decrease in upper arm dysfunction from pretest to postest among patients in experimental group as compared to control group assessed by DASH scores at significant p value <0.05
Hypothesis2-There will be a increase in quality of life from pretest to postest among patients in experimental group as compared to control group assessed by EORTC-QLQ-C30 and EORTC-QLQ-BR23 scores at significant p value <0.05
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women diagnosed with unilateral Breast cancer admitted in surgical ward and BRAIRCH oncology ward , AIIMS and are scheduled for mastectomy with axillary lymph node dissection.
- •Patients who are able to follow instructions.
- •Patients who have given consent for participation in the study.
- •Able to communicate in Hindi /English .
排除标准
- •Patients not willing to participate in the study.
- •Patients who have major health problems or disabilities like gross obesity (BMI >35 ), Cardiovascular diseases (angina , MI within last 6 months).
- •Patients having primary lymphedema and any contraindication to the affected upper-limb exercises(e.g., venous thrombosis)..
- •Patients who have cognitive dysfunction .
结局指标
主要结局
Upper arm dysfunction assessed by Disability of Arm Shoulder and Hand Questionnaire
时间窗: 3 time points,1 pretest and 2 posttest
(DASH) score from pretest to postest
时间窗: 3 time points,1 pretest and 2 posttest
次要结局
- Quality of life assessed by European organization for research and treatment of cancer quality of life questionnaire (EORTC QLQ-C30)and Breast module(EORTC-QLQ-BR23)(3 time points,1 pretest and 2 posttest)