The Effect of Inspiratory Muscle Training on Respiratory Muscle Strength, Functional Capacity, Fatigue, and Stress in Breast Cancer Patients Undergoing Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Fatigue Assessment Scale (FAS)
研究概览
简要总结
This study will address the female patients who are exposed to surgery after breast cancer. strength training for the inspiratory muscles will be applied in addition to the traditional care including physical therapy that will be compared to the effect of the traditional care alone on multiple outcome measures such as muscle strength, function, fatigue, and stress.
详细描述
Saudi Arabia reported 24,485 new cases of cancer in 2018 with 10518 cancer deaths. There were genetic, hormonal, lifestyle, obesity, and environmental risk factors associated with different cancer types.
Many of the side effects of cancer and its treatments are burdensome and significantly impact the quality-of-life quality. Exercise before, during, and after cancer treatment provides numerous beneficial outcomes such as improving physical capacity, muscle power, and psychological status. Exercise is a valuable therapeutic tool for lowering acute, long-term, and late adverse effects of cancer.
For breast cancer patients, physiotherapy is a crucial component of treatment. The physical therapy exercise program helps patients regain fitness, reduce pain, and reduce side effects caused by different cancer treatment methods. Respiratory physiotherapy is a useful procedure for maintaining and improving functional capacity, quality of life, and post-treatment sequelae after breast cancer management, which is a combination of strategies aimed at preventing, treating, and stabilizing cardiorespiratory disorders in adults.
This study aimed to evaluate the effectiveness of inspiratory muscle training in post-surgical breast cancer survivors.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Concealed allocation will be performed by a researcher who will not be involved in the treatment of assessment. Permuted blocks will be used to ensure an equal 1:1 allocation ratio. Due to the nature of the study, the assessor and the data analyzer will be blindfolded (double-blinded)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Post-operative breast cancer female patients
- •Age ≥40 years
- •All patients with Eastern Cooperative Oncology Group performance status score ≤ 2
- •Having to undergo primary treatment with surgery
排除标准
- •Severe anemia (Hb ≤ 8 g/dL)
- •Presence of underlying chronic cardiac or respiratory disease
- •severe infection, neurologic or muscular diseases prohibiting physical activity
- •uncontrolled and/or extensive brain metastases, or bone metastases that were assessed to pose a risk of pathological fractures from exercising
- •Contraindications descriped by the physician
结局指标
主要结局
Fatigue Assessment Scale (FAS)
时间窗: at follow up (3 months after the end of the treatment)
The FAS is a 10-item validated and reliable scale that will be used for evaluating symptoms of chronic fatigue.it is a self-report, paper-and-pencil measure requiring approximately 2 min for administration. Scoring each item of the FAS is answered using a five-point, Likert-type scale ranging from 1 ("never") to 5 ("always"). Items 4 and 10 are reverse-scored. Total scores can range from 10, indicating the lowest level of fatigue, to 50, denoting the highest
Functional exercise capacity evaluated by a 6-minute walk test (6MWT).
时间窗: at follow up (3 months after the end of the treatment)
The 6-minute walk test had been clinically validated, it is used to determine the effects of therapeutic interventions and prognosis. The participants will be instructed to walk as far as possible without running in six minutes, the maximum distance covered at the end of the test will be recorded
Inspiratory muscle strength by Maximal inspiratory pressure MIP
时间窗: at follow up (3 months after the end of the treatment)
Measurement of MIP will be performed using a portable electronic respiratory mouth pressure meter device (Micro RPM, Micro Medical Ltd, Kent, UK), which is a reliable and valid tool for the measurement of MIP. The MIP will be measured by deep inspiration through the mouthpiece only from the residual volume after maximal expiration. Leaning forward will not allowed during testing as it can overestimate the measurement values
Handgrip strength
时间窗: at follow up (3 months after the end of the treatment)
Handgrip strength will be measured using handheld dynamometry. Patients have to keep the elbow of the tested side in 90 degrees of flexion and a neutral position of pronation and supination while performing the test. Both sides will be tested three times and the maximal value will be retained
Perceived stress (Perceived Stress Scale pss 10)
时间窗: at follow up (3 months after the end of the treatment)
Is the most widely used psychological instrument for measuring the perception of stress? It is a measure of the degree to which situations in one's life are appraised as stressful. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived. Stress, Scores ranging from 0-13 would be considered low stress, and Scores ranging from 14-26 would be considered moderate stress
次要结局
未报告次要终点
研究者
Ahmed Abdelmoniem Ibrahim
principal investigator
University of Hail