Telehealth Exercise Intervention to Improve Cardiovascular Health in Lymphoma Survivors (TECHS): A Pilot Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Adherence to the telehealth exercise intervention
研究概览
简要总结
This clinical trial tests how well a telehealth exercise intervention works to improve cardiovascular health in lymphoma survivors. Telehealth exercise is a service to help perform physical exercises at home with a care provider online. With the use of telehealth exercise lymphoma survivors may be able to participate in exercise programs safely to improve heart health and reduce the risk of cardiovascular disease.
详细描述
PRIMARY OBJECTIVE:
I. Determine the feasibility of an 8-week telehealth exercise intervention, as assessed by enrollment, retention, and adherence to the telehealth exercise intervention.
SECONDARY OBJECTIVE:
I. Explore the effects of an 8-week telehealth exercise intervention on cardiovascular health, assessed by cardiopulmonary exercise test, pulmonary function test, body compositions, and blood biomarkers.
OUTLINE: Participants are randomized into 1 of 2 groups.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with Hodgkin or non-Hodgkin lymphoma.
- •>= 18 years old.
- •Are between 2-5 years after completing anti-cancer therapy and with no evidence of disease.
- •Intermediate (4-5) to high ( >= 6) risk of cardiovascular risk factors based on six key variables: Age 30 to 50 years (y) [2]) and >= 50y [3]; anthracycline dose >250mg/m ^ 2 [1]; hypertension [2]; diabetes [2]; smoking [1]; and chest radiation [1]).
- •Able to understand and sign the informed consent document.
- •Physically able and willing to complete all study procedures.
排除标准
- •Have overt cardiovascular disease within 6 months (e.g. myocardial infarction, stroke, angina).
- •Have contraindications to exercise.
- •Participate in structured exercise (>60 minutes/week).
- •Female patients who are pregnant or planning to become pregnant.
结局指标
主要结局
Adherence to the telehealth exercise intervention
时间窗: Up to 2 years
Adherence will be measured by the number of exercise sessions attended over the exercise sessions prescribed (17/24 sessions).
次要结局
- Effects of an 8-week telehealth exercise intervention(At baseline up to week 9)