Telehealth Based Intervention to Improve Functional Capacity in Survivors of Childhood Cancer With Significantly Limited Exercise Tolerance
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 181
- 试验地点
- 2
- 主要终点
- Exercise capacity
研究概览
简要总结
The participants are asked to take part in this clinical trial, a type of research study. The participants are SJLIFE study participants and may have a hard time exercising (exercise intolerance) due to side effects of cancer treatment received as a child.This study is being done to determine if a personalized exercise plan will help childhood cancer survivors who have exercise intolerance become more active.
Primary Objectives:
To achieve the goal of this study, we propose the following three Objectives:
Primary Objective 1:
To determine the efficacy of an individually tailored, home-delivered aerobic and strengthening intervention to improve exercise capacity in survivors of childhood cancer with exercise intolerance (peak oxygen uptake (peak VO2) <85% of age and sex predicted).
Primary Objective 2:
To determine the effects of an individually tailored, home-delivered aerobic and strengthening intervention on measures of cardiac, pulmonary, musculoskeletal, and neurosensory function in survivors of childhood cancer with exercise intolerance.
Primary Objective 3:
To determine the effects of an individually tailored, home-delivered aerobic and strengthening intervention on emotional health, participation in family and community activities, quality of life, and cognitive function in survivors of childhood cancer with exercise intolerance.
详细描述
The design for this study will be a single-blind two-arm, prospective, randomized clinical trial. Performance testing results: Both groups of participants will be provided with the results of their performance testing. Individually tailored exercise program: Individuals randomized to receive an individually tailored exercise program will meet with an exercise specialist.Generalized exercise recommendations: Individuals randomized to receive the generalized exercise recommendations will receive a copy of the Physical Activity Guidelines for Americans.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 18.00 and 39.99 years of age at the time of enrollment
- •SJLIFE participant
- •Peak VO2 <85% predicted
- •Verbalizes understanding of directions for use of ZOOM on the study provided iPad and heart rate monitor
- •Clearance for participation in exercise by a study physician
- •Internet access
排除标准
- •Enrolled in a formal exercise intervention
- •Self-report of engaging in > 150 minutes/week of moderate physical activity
- •Currently pregnant (assess by urine pregnancy test)
- •Significant psychological distress (e.g. suicidal ideation)
- •Requires immediate medical intervention (e.g. angina, decompensated heart failure)
- •Research Participant Recruitment and Screening
结局指标
主要结局
Exercise capacity
时间窗: Week 20 to 6 months after week 20
Sustainability of changes in Peak VO2/2-minute step in place test in both INT and AC groups
Exercise Capacity
时间窗: Baseline to Week 20
Changes in Peak VO2/2-minute step in place test in both INT and AC groups
次要结局
- PROMIS Ability to Participate 8a (SF v2.0)(baseline, week 20, 6 months after week 20)
- Childhood Cancer Survivor Study Neurocognitive Questionnaire - Revised (CCSS-NCQ)(baseline, week 20, 6 months after week 20)
- Patient Health Questionnaire (PHQ-9)(baseline, week 20, 6 months after week 20)
- Work and Social Adjustment Scale (WSAS)(baseline, week 20, 6 months after week 20)
- Medical Outcomes Survey Short Form (SF-36)(baseline, week 20, 6 months after week 20)
- PROMIS Global Health Short Forms(weekly during the first eight weeks and every four weeks during weeks 9-20)
- Generalized Anxiety Disorder (GAD-7)(baseline, week 20, 6 months after week 20)
- Work Productivity and Activity Impairment Questionnaire (WPAI)(baseline, week 20, 6 months after week 20)