Efficacy of Seated Exercise on Functional Capacity and Quality of Life in Patients With Leukemia During Chemotherapy Cycles
研究概览
详细说明
Cancer is a major public health that gives an economical burden on the patient and government. The incidence of different types of cell tumors are increasing nowadays. Although chemotherapy is given to kill cancer cells, it also damage normal cells and cause significant side effects while others may have more. Some CT side effects can be severe enough to require hospitalization effects. CT affects patients functional capacity and quality of life next to the cancer it self. This study is designed as randomized controlled trial to assess the impact of seated exercise on functional capacity and quality of life in patient with leukemia during chemotherapy cycles. participants will be recruited from Hematology unit, Department of General Internal Medicine, Benha University Hospitals .
The intervention protocol includes a-30 minutes seated exercise program three times a week with at least a one- day break between sessions for four weeks for the treatment group. Outcome measures will include maximum voluntary ventilation, 6 min walk test distance and FACT-G questionnaire before and after the exercise program. The program includes a five- minute warmup, 20 minutes of moderate-intensity repetitive motion exercise and a five- minute cool down.
Ethical considerations:
This study has been reviewed and approved by the Ethical Committee of Benha university. Written informed consent will be obtained from all participants or their legal guardians prior to treatment.
研究类型
注册 (估计的)
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
Inclusion Criteria:
- Male patients with age ranges from 30 to 40 years.
- All patients in this study will be on chemotherapy from at least one cycle as a treatment of leukemia.
- All patients will be hemodynamically stable.
- Patients are ambulant.
Exclusion Criteria:
- Lung cancer
- History of any pulmonary disease.
- Metastasis of lung , ribs and mediastinal structure.
- Pulmonary pathology (e.g. acute respiratory distress syndrome, or exacerbation of chronic obstructive pulmonary disease).
- Ruptured eardrum or any other condition of the ear.
- Severe bronchospasm.
- High peak air way pressure (barotraumas).
- patients with marked elevated left ventricular end- diastolic volume and pressure.
- patients with worsening haert failure signs and symptoms.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Seated exercise group
|
Participants in the intervention group will perform a structured seated exercise program during their chemotherapy cycles. The exercise program will consist of supervised, individualized seated exercises designed to improve functional capacity and quality of life. The exercise sessions will be performed according to the study protocol throughout the intervention period. Each session will consist of a five-minute warm up, 20 minutes of moderate intensity repetitive motion exercises, and a five -minute cool-down. Functional outcomes will be assessed before and after the exercise program. including maximum voluntary ventilation , six-minute walk test distance, and FACT- G quesionnaire. |
|
无干预:control group
control group will receive usual care/ standard advices
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
change in functional capacity
大体时间:Baseline and after 4 weeks of intervention
|
Functional capacity will be assessed by the six-minute walk test (6MWT) distance before and after the four week seated exercise programe.
|
Baseline and after 4 weeks of intervention
|
|
change in quality of life
大体时间:Baseline and after 4 weeks of intervention
|
Quality of life will be assessed using the Functional Assessment of Cancer Therapy General (FACT-G) questionnaire before and after week seated exercise programe.
the total FACT-G score ranges from 0 to 108, with higher scores indicating better quality of life
|
Baseline and after 4 weeks of intervention
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Maximum Voluntary Ventilation (MVV)
大体时间:Baseline and after 4 weeks of intervention
|
Change in Maximum Voluntary Ventilation (MVV) will be assessed before and after the four week seated exercise program
|
Baseline and after 4 weeks of intervention
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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