Remotely Monitored Rehabilitation in Hemato-oncological Survivors After Treatment: The Tele@Home Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Cardiorespiratory fitness
研究概览
简要总结
This study investigates whether the 12-week home-based exercise training with remote guidance and telemonitoring compared to regular center-based training leads to better long-term cardiorespiratory fitness and physical activity levels in post-treatment patients with lymphoma.
详细描述
80 lymphoma cancer patients post-treatment (except adjuvant treatment) will be enrolled in the study. Cardiorespiratory fitness (peak oxygen consumption), adverse events, body composition, quality of life, costs and adherence to exercise prescription will be evaluated at baseline, 12-week, and year after enrollment.
Investigators assume that home-based training with remote guidance and telemonitoring with objective training data obtained during rehabilitation after cancer treatment will improve long-term motivation and effectiveness of independent training in cancer survivors, resulting in superior cardiorespiratory fitness and physical activity levels.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants
- •with hemato-oncological malignancy / lymphoma (in last two months)
- •after cancer systemic chemotherapy-based treatment
- •with clinically stable state
- •with the ability to perform a cardiopulmonary exercise test
- •with the ability to understand and write in the Czech language
- •with an internet connection at home
- •literacy with information and communication technology
排除标准
- •Participants
- •with acute heart disease or decompensation in the previous six weeks,
- •with psychological severe, cognitive disorders,
- •serious training limitations (musculoskeletal disorders)
- •currently carried out the recommendations for physical activity (150min per week)
- •who take part in a training program under supervision elsewhere
结局指标
主要结局
Cardiorespiratory fitness
时间窗: Change from baseline to 12 weeks and 52 weeks
Peak oxygen uptake during cardiopulmonary exercise test
次要结局
- Satisfaction - self-completed questionnaire(12 weeks and 52 weeks)
- Muscle mass(Change from baseline to 12 weeks and 52 weeks)
- Incidence of exercise adverse events assessed by 5 grade scale(Data will be recorded continuously from the intervention's baseline for 12 weeks and then for 52 weeks)
- Body water(Change from baseline to 12 weeks and 52 weeks)
- Health-related quality of life(Change from baseline to 12 weeks and 52 weeks)
- Training adherence (Number of compliant participants)(12 weeks)
- Body fat percentage(Change from baseline to 12 weeks and 52 weeks)
- Maximum Grip Strength(Change from baseline to 12 weeks and 52 weeks)
研究者
Ladislav Batalik
Principal Investigator
Brno University Hospital