Investigating Various Adaptive-Training Exercise Programs for Improving Cardiorespiratory Fitness After Breast Cancer Treatment (ACTIVATE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Intervention Feasibility
研究概览
简要总结
This clinical trial studies the feasibility of implementing various adaptive training exercise programs to improve cardiorespiratory fitness in patients after receiving breast cancer treatment. Information from this study may help researchers better understand how to implement adaptive training interventions to improve cardiorespiratory fitness in patients after receiving breast cancer treatment.
详细描述
OUTLINE: Patients are randomized to the interventional groups or control group.
INTERVENTION GROUPS: Patients are randomized to 1 of 2 interventional arms.
ARM I: Patients participate in aerobic exercise (AE) sessions 3 times per week for 12 weeks. After 12-weeks, non-responders participate in combined AE and resistance exercise (RE) sessions for an additional 12 weeks, while responders continue participating in the AE sessions alone for an additional 12 weeks.
ARM II: Patients participate in RE sessions 3 times per week for 12 weeks. After 12-weeks, non-responders may participate in a further 12-weeks of combined AE and RE sessions, while responders continue participating in the RE sessions alone for an additional 12 weeks.
CONTROL GROUP: After 24 weeks, patients receive a digital copy of the 12-week AE sessions and 12-week RE sessions and an outline of sessions for 24 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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 75 years, inclusive
- •Female gender
- •Prior diagnosis of invasive breast cancer
- •Completion of chemotherapy or receipt of trastuzumab (Herceptin) therapy within the past 6 - 60 months (0.5 - 5 years)
- •Reduced cardiorespiratory functional capacity, defined as below the median estimated CRF for age/sex-matched controls
排除标准
- •Actively receiving radiation treatment
- •Medical history of heart failure, coronary artery disease or arrhythmia
- •Contraindications to cardiopulmonary exercise testing (CPET)
- •Contraindications to magnetic resonance imaging (MRI) (e.g ferromagnetic cerebral aneurysm clips or other intraorbital/intracranial metal; pacemakers, defibrillators, functioning neurostimulator devices, non-compatible MRI tissue expanders or breast implants, or other implanted non-compatible MRI devices), weight over 550 lbs, or symptomatic claustrophobia
- •Contraindications to exercise, including a history of surgery with sequelae that restrict ability to exercise safely or comfortably
- •Unwilling to complete intervention procedures or outcome measures
研究组 & 干预措施
Arm I (aerobic exercise)
Patients participate in AE sessions 3 times per week for 12 weeks. After 12-weeks, non-responders participate in combined AE and RE sessions for an additional 12 weeks, while responders continue participating in the AE sessions alone for an additional 12 weeks.
干预措施: Aerobic Exercise Intervention (Other)
Arm I (aerobic exercise)
Patients participate in AE sessions 3 times per week for 12 weeks. After 12-weeks, non-responders participate in combined AE and RE sessions for an additional 12 weeks, while responders continue participating in the AE sessions alone for an additional 12 weeks.
干预措施: Resistance Exercise Intervention (Other)
Arm I (aerobic exercise)
Patients participate in AE sessions 3 times per week for 12 weeks. After 12-weeks, non-responders participate in combined AE and RE sessions for an additional 12 weeks, while responders continue participating in the AE sessions alone for an additional 12 weeks.
干预措施: Quality-of-Life Assessment (Other)
Arm II (resistance exercise)
Patients participate in RE sessions 3 times per week for 12 weeks. After 12-weeks, non-responders may participate in a further 12-weeks of combined AE and RE sessions, while responders continue participating in the RE sessions alone for an additional 12 weeks.
干预措施: Aerobic Exercise Intervention (Other)
Arm II (resistance exercise)
Patients participate in RE sessions 3 times per week for 12 weeks. After 12-weeks, non-responders may participate in a further 12-weeks of combined AE and RE sessions, while responders continue participating in the RE sessions alone for an additional 12 weeks.
干预措施: Resistance Exercise Intervention (Other)
Arm II (resistance exercise)
Patients participate in RE sessions 3 times per week for 12 weeks. After 12-weeks, non-responders may participate in a further 12-weeks of combined AE and RE sessions, while responders continue participating in the RE sessions alone for an additional 12 weeks.
干预措施: Questionnaire Administration (Other)
Arm II (resistance exercise)
Patients participate in RE sessions 3 times per week for 12 weeks. After 12-weeks, non-responders may participate in a further 12-weeks of combined AE and RE sessions, while responders continue participating in the RE sessions alone for an additional 12 weeks.
干预措施: Quality-of-Life Assessment (Other)
Control Group (digital exercise interventions)
After 24 weeks, patients receive a digital copy of the 12-week AE sessions and 12-week RE sessions and an outline of sessions for 24 weeks.
干预措施: Exercise Intervention: Digital copies and outline of sessions (Other)
Control Group (digital exercise interventions)
After 24 weeks, patients receive a digital copy of the 12-week AE sessions and 12-week RE sessions and an outline of sessions for 24 weeks.
干预措施: Questionnaire Administration (Other)
Control Group (digital exercise interventions)
After 24 weeks, patients receive a digital copy of the 12-week AE sessions and 12-week RE sessions and an outline of sessions for 24 weeks.
干预措施: Quality-of-Life Assessment (Other)
结局指标
主要结局
Intervention Feasibility
时间窗: Week 24
Will be determined with all-cause intervention discontinuation rate, which is the proportion of all intervention participants who permanently stop the intervention prior to week 24 for any reason.
次要结局
- Intervention Session Intensity(Up to 24 weeks)
- Study Feasibility(Up to 24 weeks)
- Intervention Acceptability(Up to 24 weeks)
- Intervention Safety: Adverse Events(Up to 24 weeks)
- Intervention Adherence(Up to 24 weeks)
研究者
Kerryn Reding
Associate Professor
University of Washington