Feasibility, Acceptability, and Effects of Combined Aerobic and Resistance Exercise in Breast Cancer Survivors: A Pilot Study (the CARE Study)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 4
- 主要终点
- Recruitment and enrollment feasibility
研究概览
简要总结
The overall aim of this research is to assess the feasibility of a 12-week combined aerobic exercise (AEx) and resistance exercise (REx) intervention and elucidate the impact of AEx/REx on several physiological and behavioral components of energy balance among breast cancer survivors (BCS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
Masking is not possible because this is a single-arm exercise study.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female sex
- •Age: 18 - 45 years
- •Body mass index [BMI]: 25 - 35 kg/m2
- •Pre-menopausal before cancer diagnosis and treatment
- •<1 hour/week of planned physical activity by self-report in the previous 12 months
- •Diagnosis of primary stage I - III estrogen receptor/progesterone receptor-positive (ER/PR+) breast cancer, according to institutional standards.
- •All chemotherapy, radiation, and surgery completed at least two weeks (14 days), but less than 6 months prior to registration
排除标准
- •Self-reported diabetes mellitus, untreated/uncontrolled thyroid disease, history of cardiovascular disease or symptoms suggestive of cardiovascular disease (chest pain, shortness of breath at rest or with mild exertion, syncope), cancer diagnosis in the last 5 years before breast cancer (any site, excluding skin cancer), or any other medical condition affecting weight or energy metabolism.
- •Uncontrolled hypertension defined as: systolic blood pressure >160 mmHg or diastolic blood pressure >100mmHg, as measured during the screening visit. Participants who are deemed ineligible based upon uncontrolled hypertension criteria will be referred to their primary care physicians for treatment. If this condition becomes controlled they will be allowed to be re-evaluated for inclusion in the current trial.
- •Unable to exercise due to cardiac, pulmonary, neurological, orthopedic reasons.
- •Currently smoking and/or nicotine use.
- •Treatment with medications known to significantly affect appetite, weight, energy intake or expenditure in the last 3 months (e.g. appetite suppressants, lithium, stimulants, anti-psychotics, tricyclic antidepressants).
- •Corticosteroid use within the last two weeks
- •History of surgical procedure for weight loss at any time (e.g. gastroplasty, gastric bypass, gastrectomy or partial gastrectomy, adjustable banding, gastric sleeve); history of extensive bowel resection for other reasons
- •Currently pregnant, lactating or less than 6 months post-partum.
- •Score of ≥ 2 on the CAGE (cut-annoyed-guilty-eye opener) questionnaire adapted to include drug use55
- •Score of > 20 on the Eating Attitude Test - 26 (EATS-26), indicative of disordered eating. Participants with a score >20 on the EATS-26 will be referred to their primary care physician for further evaluation.
- •Significant food intolerances/allergies that cannot be accommodated by the University of Colorado Hospital Clinical Translational Research Center Metabolic Kitchen.
- •Currently participating in any formal weight loss or physical activity programs or clinical trials for weight loss.
- •Other medical, psychiatric, or behavioral limitations that may interfere with participation (as determined by study physician).
- •Unable or unwilling to undergo study procedures
结局指标
主要结局
Recruitment and enrollment feasibility
时间窗: Through study completion, up to two years
Number of individuals approached, meeting inclusion criteria, reasons for exclusion, and enrolled in the study
Subjective exercise adherence
时间窗: Changes across weeks 4, 8, and 12
Participants will be asked to rate on a 1-10 Likert scale: 1) how adherent they were to the prescribed exercise over the past week, 2) how difficult it was to adhere to the prescribed exercise over the past week, and 3) how likely they feel they can adhere to the prescribed exercise for the next month.
Exercise self efficacy
时间窗: Changes across weeks 4, 8, and 12
Self Efficacy for Exercise Scale; 9 items; score range: 0-9, with higher scores indicating higher exercise self-efficacy
Objective exercise adherence
时间窗: 12 weeks
Adherence to additional study-specific AEx will be tracked through heart rate monitor data, logs of attendance, and participant diaries and compared to the REx-only intervention
Exercise enjoyment
时间窗: Changes across weeks 4, 8, and 12
Physical Activity Enjoyment Scale; 8 items; range: 7-56, with higher scores indicating higher exercise enjoyment
Intervention acceptability
时间窗: 12 weeks
Subjective ability to adhere to combined AEx/REx
次要结局
- Changes in peptide-YY (PYY)(Baseline, 12 weeks)
- Changes in ghrelin(Baseline, 12 weeks)
- Changes in sedentary behavior(Baseline, 12 weeks)
- Changes in physical activity(Baseline, 12 weeks)
- Changes in subjective appetite ratings(Baseline, 12 weeks)
- Changes in ad libitum energy intake(Baseline, 12 weeks)