Effects of Inspiratory Muscle Training Among Breast Cancer Patients Undergoing Active Treatment (IMACT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Maximum inspiratory pressure
研究概览
简要总结
This clinical trial studies whether breathing exercises for the muscles that help with breathing air in, inspiratory muscle training (IMT), works to improve breathing muscle strength, shortness of breath, and physical activity levels in women who are receiving chemotherapy for early-stage breast cancer (BC). Cancer and/or treatments for BC can directly result in muscle wasting that involves breathing muscles, skeletal muscles or heart muscles. Pain, weakness, shortness of breath, and side effects of cancer treatment may lead to lower physical activity levels. IMT involves breathing exercises using a small hand-held device. The device makes it a little harder to breathe in, which may help strengthen breathing muscles. IMT may be an effective way to improve breathing muscle strength, shortness of breath, and physical activity levels in women who are receiving chemotherapy for early-stage BC.
详细描述
PRIMARY OBJECTIVE: To investigate the effects of 8 weeks of IMT on inspiratory muscle strength, exertional dyspnea, and physical activity levels among women undergoing chemotherapy for BC.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM 1: Patients complete three sets of fifteen repetitions per session of low-intensity IMT over 15-20 minutes four days a week for 8 weeks.
ARM 2: Patients complete three sets of fifteen repetitions per session of high-intensity IMT over 15-20 minutes four days a week for 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
Participants will be blinded to the intervention.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Within 3 weeks of starting chemotherapy for an early-stage breast cancer diagnosis
- •Able to exercise independently without needing support
- •Ability to read, speak, understand English
排除标准
- •Metastatic breast cancer
- •Unwilling or unable to follow protocol requirements
- •Any significant health condition which in the investigator's opinion increases the risks of participation or makes the participant unsuitable for the study
研究组 & 干预措施
Arm 1 (low-intensity IMT)
Patients complete three sets of fifteen repetitions per session of low-intensity IMT over 15-20 minutes four days a week for 8 weeks.
干预措施: Inspiratory muscle training (Behavioral)
Arm 2 (high-intensity IMT)
Patients complete three sets of fifteen repetitions per session of high-intensity IMT over 15-20 minutes four days a week for 8 weeks.
干预措施: Inspiratory muscle training (Behavioral)
结局指标
主要结局
Maximum inspiratory pressure
时间窗: Baseline to 8 weeks
Measure of the strength of the inspiratory muscles. Units: cm H20
次要结局
- Physical activity levels(Baseline to 8 weeks)
- Modified Medical Research Council Dyspnea scale rating(Baseline to 8 weeks)
- Dyspnea 12 score(Baseline to 8 weeks)
- RAND-36 Quality of life(Baseline to 8 weeks)
- FACIT-F(Baseline to 8 weeks)
研究者
Dharini Bhammar
Principal Investigator
Ohio State University Comprehensive Cancer Center