Exercise, Gut Microbiome, and Breast Cancer: Increasing Reach to Underserved Populations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Feasibility - Adherence to study protocol activities
研究概览
简要总结
Understanding the impact exercise has on a cancer survivor's gut microbiome can improve the health and well-being of cancer survivors by enhancing treatments targeting the gut microbiome. Although scientific studies support a link between exercise and the gut microbiome, rigorous randomized trials needed to confirm this causal link are limited and usually involve supervised exercise. Hence, this proposal tests feasibility of a home-based, remote-only research protocol that is more accessible to cancer survivors unable to attend supervised exercise including but not limited to rural populations. This study will also determine if exercise effects on the gut microbiome differ by factors such as race.
详细描述
Forty physically inactive breast cancer survivors will be randomized into 10-week conditions of home-based aerobic exercise training or standard attention control. All participants will be asked to maintain their pre-study diet and attempt to maintain their body weight while participating in the study. Assessments will occur at baseline, week 5 (mid-intervention), and week 10 (post-intervention) by videoconference platform. Study feasibility and changes in the gut microbiome will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Staff doing assessments will be masked to study group allocation
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Non-Hispanic white or black women
- •Age 18-70 years
- •History of breast cancer stage 0, I, II, or III
- •≥1 year post-primary cancer treatment completion
- •English speaking
- •Ambulates without assistance
- •No antibiotics in past 90 days
- •Willing to avoid taking probiotics during the study
- •Has access to a safe place to perform aerobic exercise (e.g., willing to walk in neighborhood or has gym membership or owns relevant exercise equipment at home, etc.)
- •Has access to good internet and WIFI and device capable of videoconferencing (the study has limited resources to loan tablets and hotspots)
排除标准
- •Metastatic or recurrent cancer
- •Another cancer diagnosis in the past 5 years (not including skin or cervical cancer in situ)
- •Unstable angina
- •New York Heart Association class II, III, or IV congestive heart failure
- •Uncontrolled asthma
- •Interstitial lung disease
- •Current steroid use
- •Told by a physician to only do exercise prescribed by a physician
- •Dementia or organic brain syndrome
- •Schizophrenia or active psychosis
- •Connective tissue or rheumatologic disease
- •Participating in >30 minutes of exercise on ≥3 days/week in the past six months
- •Anticipate elective surgery, medication changes or antibiotics during the study
- •Contraindication to ≥moderate intensity aerobic exercise
- •Physical limitations that prevent engaging in ≥moderate intensity aerobic exercise
- •Breastfeeding, pregnant or anticipate pregnancy during the study
- •Plan to move residence during the study
- •Plan to travel for more than 1 week during the study
- •Anticipate trouble attending the weekly study videoconference calls
- •History of bariatric surgery
- •Body weight greater than 440 lbs
- •Any social, psychological, or physical condition that interferes with the participant's ability to complete study activities or unduly increases study risk
结局指标
主要结局
Feasibility - Adherence to study protocol activities
时间窗: Throughout 10 week study period
Feasibility measure (e.g. percent of assessments and intervention sessions completed
Feasibility - Attrition rates
时间窗: Throughout 10 week study period
Feasibility measure of the number of participants who dropout or are withdrawn
Feasibility - Adverse events
时间窗: Throughout 10 week study period
Feasibility measure of the number of adverse events recorded by staff during the study period
Feasibility - Participant satisfaction
时间窗: At conclusion of 10 week study period
Self-Administered survey given to the participant at the conclusion of the 10 week study period
Feasibility - Recruitment
时间窗: Baseline
Number of participants excluded or not agreeing to participate will be measured
次要结局
- Change in physical performance(10 weeks after baseline)
- Sleep dysfunction measured through specific questionnaire(10 weeks after baseline)
- Accelerometer Measured Free-living physical activity (e.g., minutes of activity)(10 weeks after baseline)
- Depression and Anxiety measured through specific questionnaire(10 weeks after baseline)
- Pain measured through Patient Reported Outcomes Measurement Information System [PROMIS®](10 weeks after baseline)
- Post-traumatic stress measured through specific questionnaire(10 weeks after baseline)
- Composition of gut microbiota as measured by fecal samples(10 weeks after baseline)
- Fatigue measured through fatigue specific questionnaire(10 weeks after baseline)
- Body fat percentage analysis using a Tanita bioelectrical impedance analysis scale(10 weeks after baseline)
- Muscle mass analysis using a Tanita bioelectrical impedance analysis scale(10 weeks after baseline)
- Body Mass Index analysis using a Tanita bioelectrical impedance analysis scale(10 weeks after baseline)
研究者
Laura Q. Rogers, MD, MPH
Professor, Med - Preventive Medicine
University of Alabama at Birmingham