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Telerehabilitation and Lymphoma Patients

2022年7月19日 更新者:Ladislav Batalik、Brno University Hospital

Effect of the Physical Exercise Training Using Telerehabilitation Among Lymphoma Patients: A Pilot Study

This study aims to examine the feasibility and effect of a home-based short-term telerehabilitation exercise intervention using heart rate monitor and internet platform in patients with lymphoma.

研究概览

详细说明

Fifteen lymphoma cancer patients post-treatment (except adjuvant treatment) will be enrolled in the study. Cardiorespiratory fitness (peak oxygen consumption), adverse events, body composition and adherence to exercise prescription will be evaluated at baseline, 12-week, and year after enrollment.

研究类型

介入性

注册 (实际的)

15

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Brno、捷克语、62500
        • University Hospital Brno

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Lymphoma patients post-treatment (except ongoing adjuvant treatment)
  • Post-treatment period not exceeding 3 months
  • Internet connection at home
  • Literacy with information and communication technology
  • Patients who agreed with informed consent

Exclusion Criteria:

  • Inability to perform a cardiopulmonary exercise test
  • Psychological severe or cognitive disorders
  • Contraindications for cardiopulmonary exercise testing
  • Other exercise limitations (musculoskeletal disorders)
  • Planned intervention or operation
  • Participants who are enrolled in or participate in other rehabilitation program
  • Participants who plan to be or are included in other studies

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Home-based telerehabilitation exercise
Exercise training is conducted in the patient's home conditions using modern technology to transfer medical data remotely - the participants receive a heart rate monitor and sensor. To know what to do and how to exercise, the first (1-2) exercise training sessions will be controlled by the physiotherapist in a rehabilitation clinic in the hospital, who creates individual exercise training for each patient. The patient's training data will be downloaded and updated regularly via the internet platform and clinicians will evaluate these results and provide patients with telephone feedback.
Eligible participants will undergo 12 weeks of physical exercise using a heart rate monitor and internet platform at home. The participants will regularly (minimum once per week) upload the exercise data from the heart rate monitor into the internet platform. An exercise telerehabilitation session consists of the warm-up phase, aerobic phase (30 - 50 minutes gradually increasing exercise duration; heart rate zone based on baseline cardiopulmonary exercise test) and cool-down phase. The exercise training period is set to 3 times a week for 12 weeks. Study participants will receive user guides developed by research team with detailed instructions regarding equipment set-up, training protocol, and contact information. Also, participants will receive weekly phone calls from week 0 to week 12 to monitor adverse events, encourage compliance and adherence to the study protocol, address any subject questions or concerns, and collect information regarding participants' current symptomatology.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Cardiorespiratory fitness (CRF)
大体时间:Change from baseline to 12 weeks and 1-year
Peak oxygen uptake (VO2peak) during the cardiopulmonary exercise test
Change from baseline to 12 weeks and 1-year

次要结果测量

结果测量
措施说明
大体时间
Body composition (Total muscle mass in kilograms)
大体时间:Change from baseline to 12 weeks and 1-year
Total muscle mass is the amount of muscle in body, including skeletal muscles, smooth muscles, and cardiac muscles. Total muscle mass will be measured by bioelectrical impedance analysis.
Change from baseline to 12 weeks and 1-year
Body composition (Body fat mass in kilograms)
大体时间:Change from baseline to 12 weeks and 1-year
Body fat mass is the actual weight of fat in body. Body fat mass will be measured by bioelectrical impedance analysis.
Change from baseline to 12 weeks and 1-year
Body composition (Body weight in kilograms)
大体时间:Change from baseline to 12 weeks and 1-year
Body weight is the measurement of weight without items located on the person. Body weight will be measured by bioelectrical impedance analysis.
Change from baseline to 12 weeks and 1-year
Incidence of treatment-emergent adverse events assessed by 5 grade scale
大体时间:Data will be recorded continuously from the baseline to 12 weeks
Participants will be encouraged to use the contact details for reporting the incidence of treatment-emergent adverse events at any time throughout the study period. The type, incidence, and severity of adverse events by scale (Grade 1: Mild, asymptomatic or mild symptoms; Grade 2: Moderate, minimal; Grade 3: Severe or medically significant; Grade 4: Life-threatening consequences; and Grade 5: Death) will be noted
Data will be recorded continuously from the baseline to 12 weeks
Exercise adherence
大体时间:12 weeks
Exercise adherence is defined as number of exercise sessions attended of a possible 36 offered by the exercise intervention program. Exercise adherence will be determined by participant exercise web datasheet review at 12 weeks.
12 weeks
Exercise compliance
大体时间:12 weeks
Number of participants who attend atleast 70% of prescribed exercise sessions measured by exercise datasheet at 12 weeks. (70% of prescribed exercise sessions = 25 exercise sessions in 12 weeks)
12 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年4月1日

初级完成 (实际的)

2022年4月26日

研究完成 (实际的)

2022年5月31日

研究注册日期

首次提交

2021年3月26日

首先提交符合 QC 标准的

2021年3月26日

首次发布 (实际的)

2021年3月30日

研究记录更新

最后更新发布 (实际的)

2022年7月20日

上次提交的符合 QC 标准的更新

2022年7月19日

最后验证

2022年7月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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