Halt Aging in Survivors of Blood Cancers: the HALTAging-1 Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Percentage of participants who adhered to the exercise regimen at 6-months post enrollment.
研究概览
简要总结
Older survivors of blood cancer are at a high risk of accelerated biological aging, which increases their risk of developing multiple aging-related conditions. Whereas physical exercise can improve overall health, older cancer survivors do not meet the recommended physical activity, highlighting the need to develop behavioral interventions to increase adherence. Several other knowledge gaps exist to implement exercise interventions in older survivors of blood cancer; the dose and duration of exercise necessary to slow biological aging in older blood cancer survivors remain unknown. To bridge these gaps in knowledge, we have designed a Phase 2 randomized control trial to test the effects of behavioral and exercise interventions on various outcomes.
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
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥50 years
- •A history of hematological malignancy
- •Participants must be able to and willingly give informed consent
排除标准
- •Patients receiving intensive induction or consolidation chemotherapy. Maintenance chemotherapy, or lower-intensity chemotherapy for an indolent hematological malignancy is allowed.
- •Neurodegenerative disease (e.g. Alzheimer's dementia), stroke, or uncontrolled psychotic disorders (e.g. schizophrenia or bipolar disorder) in the past 3 months if those disorders are considered significant enough to impair participation in the study.
- •Illnesses such as clinical evidence of decompensated heart failure, unstable angina, or orthopedic or neuromuscular disorders that could limit safe participation in aerobic exercise.
- •Cardiopulmonary exercise test results that preclude safe exercise (e.g., life-threatening arrhythmia, balance difficulties, peak VO2 <10 ml/kg/min).
- •Estimated life expectancy of less than 6 months (that precludes assessment of study primary endpoint).
- •Self-reported pregnancy or the possibility of pregnancy.
- •Participants who do not plan to follow up at the participating center.
研究组 & 干预措施
Intervention Arm: Exercise + Behavioral Coaching
Intervention arm incorporating virtually supervised moderate-intensity aerobic exercise and behavioral intervention/coaching to improve adherence
干预措施: Behavioral Coaching Intervention (Behavioral)
Intervention Arm: Exercise + Behavioral Coaching
Intervention arm incorporating virtually supervised moderate-intensity aerobic exercise and behavioral intervention/coaching to improve adherence
干预措施: Virtual Exercise Platform (Behavioral)
Enhanced Usual Care-Virtual Gym
Participants will receive access to a virtual exercise platform, and educational sessions but will not receive behavioral coaching
干预措施: Virtual Exercise Platform (Behavioral)
结局指标
主要结局
Percentage of participants who adhered to the exercise regimen at 6-months post enrollment.
时间窗: 6 Months from start of program
Participants achieving at least 120 minutes per week of moderate-intensity aerobic exercise, measured using Polar heart rate monitor data and exercise diaries.
Percentage of participants who adhered to the exercise regimen at 12-months post enrollment.
时间窗: 12 Months from start of program.
Participants achieving at least 120 minutes per week of moderate-intensity aerobic exercise, measured using Polar heart rate monitor data and exercise diaries to assess sustainability of adherence.
次要结局
未报告次要终点