Efficacy of Seated Exercise on Functional Capacity and Quality of Life in Patients With Leukemia During Chemotherapy Cycles
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- change in functional capacity
研究概览
简要总结
This study aims to evaluate the efficacy of seated exercise on functional capacity and quality of life in patients with leukemia during chemotherapy cycles Participants will receive efficacy of seated exercise on functional capacity and quality of life in patients with leukemia during chemotherapy cycles over a defined period. Outcomes will be assessed using Pulmonary function test, 6 min walk test and FACT- G questionnaire to determine improvements in quality of life in cancer patient rehabilitation special to diagnosed with leukemia.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Seated exercise group
干预措施: Seated exercise (Behavioral)
control group
control group will receive usual care/ standard advices
结局指标
主要结局
change in functional capacity
时间窗: 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.
change in quality of life
时间窗: 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
次要结局
- Change in Maximum Voluntary Ventilation (MVV)(Baseline and after 4 weeks of intervention)
研究者
Aya salah el din fouad rostom
Lecturer of physical therapy for general surgery, Burn and skin, Suez university, Suez ,Egypt
Suez University