Investigation of the Effectiveness of Exercise Training During Radiotherapy in Postoperative Breast Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Shoulder joint range of motion (ROM) of patients during radiotherapy protocol
研究概览
简要总结
The main purpose of our study is to investigate the effects of exercise therapy on upper extremity functions in patients receiving radiotherapy to the axillary region after breast cancer surgery.
详细描述
Our study will take in place in radiation oncology clinic. In routine the patients which will receive axillary area radiotherapy will randomized into 2 groups will explained in study arms section later. There are papers explained about radiotherapy side effects to upper extremity functions. But there is lack of evidence about exercise therapy during radiotherapy protocol to cope with its side effects to upper extremity functions. In this study we will compare two groups upper extremity function related outcomes at the end of the radiotherapy sessions and also before and after results for two groups.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients İn the age range of 18-65
- •Receiving radiotherapy to the axillary region after surgery with breast cancer diagnosis
排除标准
- •xclusion Criteria:
- •Radiotherapy area to contain only the chest wall
- •Any orthopedic injury or trauma involving the upper extremity prior to or during the cancer diagnosis
- •The presence of metastases in any area other than breast tissue
研究组 & 干预措施
exercise intervention group
This group will be taken an exercise intervention during their radiotherapy programme.
干预措施: exercise intervention (Other)
routine radiotherapy protocol
This group will not be taken into an exercise intervention during their radiotherapy programme.
干预措施: routine radiotherapy protokol (Other)
结局指标
主要结局
Shoulder joint range of motion (ROM) of patients during radiotherapy protocol
时间窗: ''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed''
Shoulder range of motion in flexion, abduction, internal rotation and external rotation will be evaluated by the standard goniometer. Total Active and passive degree of ROM will be evaluated in patient sitting position. Total ROM will record in degree value.
Upper extremity functional status of patients during radiotherapy protocol
时间窗: ''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed''
The subjective upper extremity functional status will assessed by The Disabilities of the Arm, Shoulder and Hand Score (DASH). This is 30 questions Questionnaire and 21 evaluate the person's difficulties during daily activities, 5 of them (pain, stiffness, tingling, weakness) and 4 of them evaluate work, sleep, social function and self-confidence. The person answers all questions according to the 5-point Likert system (1: no difficulty, 2: mild difficulty, 3: moderate difficulty, 4: extreme difficulty, 5: inability). A score of 0-100 is obtained from each section. As the score increases, the disability increases.
Hand Grip force measurement of patients during radiotherapy protocol
时间窗: ''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed''
Jamar hand dynamometer will be used for to evaluate gross hand grip force. While the patient is sitting with a back support in a comfortable seat, he will be asked to grasp the dynamometer with a gross grip at 90˚ flexion and compress it as strong as she can. 3 measurements will be made for both hands and the average of the values in kg will be recorded.
次要结局
- Breast cancer specific life quality of patients during radiotherapy protocol(''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed'')
- Pain and sensory impairment of patients during radiotherapy protocol(''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed'')
- Upper extremity kinesthesia and shoulder joint position sensation of patients during radiotherapy protocol(''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed'')
- Fear of movement, avoidance reaction of patients during radiotherapy protocol(''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed'')
- Scapular dyskinesia of patients during radiotherapy protocol(''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed'')
- Physical activity level of patients during radiotherapy protocol(''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed'')
- Lymph edema evaluation of patients during radiotherapy protocol(''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed'')
- Life quality of patients during radiotherapy protocol(''day1 before radiotherapy session,'' ''after 6 week sessions of radiotherapy completed'')
研究者
Damlagül AYDIN ÖZCAN
research assistant
Hacettepe University