Reducing Exercise Intolerance Through Inspiratory Muscle Training in Obese Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Change in exercise tolerance
研究概览
简要总结
The investigators propose a randomized controlled trial to determine the effectiveness of inspiratory muscle training in improving exercise tolerance among stage 0-III obese breast cancer survivors.
详细描述
Randomized controlled trial (RCT) where obese participants (N=133) are randomized to 2 arms: [i] IMT 4 wks + Exercise 12 wks, [ii] SHAM 4 wks + Exercise 12 wks).
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
- Double (Participant, Outcomes Assessor)
盲法说明
Staff completing outcomes testing and study participants will be blinded to treatment assignment (IMT/SHAM). The IMT/SHAM devices are the same with ability to alter resistance; however, upon use at the lower intensity, the participant may be able to tell whether the device has resistance.
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
- •completed active treatment for a Stage 0-III breast cancer diagnosis within 6 months to 5 years of enrollment.
- •obese as defined by a body mass index (BMI) of 30 to 50 kg/m2
- •patients who are on adjuvant endocrine therapy will be allowed to participate.
- •sedentary (participating in less than 90 min of moderate intensity activity per week) and have at least one limitation in activity on the 10-question RAND-36 Physical Function Subscale to ensure some exercise intolerance
排除标准
- •functional limitations that make independent exercise unsafe
- •metastatic breast cancer
- •ongoing or active infection with recent antibiotics or steroids
- •Bilateral Axillary lymph node dissection (ALND) of >5 lymph nodes on each side, which could increase risk of lymphadenopathy with repeated blood pressure measurements during exercise or if patient has been advised by their clinician to avoid repeated BP measures on both arms. Bilateral Sentinel Lymph Node Biopsy (SLNB) will be allowed.
- •heart disease precluding exercise (congestive heart failure, unstable angina pectoris, cardiac arrhythmia)
- •psychiatric illness/social situations that would limit compliance with study requirements
- •orthopedic or neuromuscular disorders or arthritis that preclude participation in exercise
- •unwilling or unable to follow protocol requirements
- •pregnant or nursing
- •any condition which in the investigator's opinion deems the subject an unsuitable candidate to participate in this study
- •presence of provokable ECG changes suggestive of heart disease, or dangerous arrhythmias or exercise induced hypertension, etc. during the cardiopulmonary exercise test
- •non-English speaking
研究组 & 干预措施
4 wk IMT + 12 wk exercise
4 weeks of IMT, 3/week, 3 sets of 15 repetitions, intensity up to 70% of MIP using a pressure threshold device PLUS 12 weeks of aerobic exercise training including cycling, walking, elliptical, starting in week 5, 3/week, up to 50min per session, moderate intensity
干预措施: Exercise training (Behavioral)
4 wk IMT + 12 wk exercise
4 weeks of IMT, 3/week, 3 sets of 15 repetitions, intensity up to 70% of MIP using a pressure threshold device PLUS 12 weeks of aerobic exercise training including cycling, walking, elliptical, starting in week 5, 3/week, up to 50min per session, moderate intensity
干预措施: Inspiratory muscle training (Behavioral)
4 wk SHAM + 12 wk exercise
4 weeks of SHAM training, 3/week, 3 sets of 15 repetitions, intensity up of 10% of MIP using a pressure threshold device PLUS 12 weeks of aerobic exercise training including cycling, walking, elliptical, starting in week 5, 3/week, up to 50min per session, moderate intensity
干预措施: Exercise training (Behavioral)
结局指标
主要结局
Change in exercise tolerance
时间窗: Baseline to 16 weeks
Continuous variable assessed as time to exhaustion during a CWRET at 80% of peak work rate. Units: minutes.
Change in exercise tolerance
时间窗: Baseline to 4 weeks
Continuous variable assessed as time to exhaustion during a CWRET at 80% of peak work rate. Units: minutes.
次要结局
- Change in inspiratory muscle endurance(Baseline to 16 weeks)
- Change in fatigue(Baseline to 16 weeks)
- Change in exercise capacity(Baseline to 16 weeks)
- Change in dyspnea(Baseline to 16 weeks)
- Change in inspiratory muscle strength(Baseline to 16 weeks)
- Change in inspiratory muscle strength(Baseline to 4 weeks)
- Change in inspiratory muscle endurance(Baseline to 4 weeks)
- Change in exercise capacity(Baseline to 4 weeks)
- Change in dyspnea(Baseline to 4 weeks)
- Change in fatigue(Baseline to 4 weeks)
研究者
Dharini Bhammar
Assistant Professor
Ohio State University Comprehensive Cancer Center