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Virtual Exercise Program in Interstitial Lung Disease (ILD) Patients

2022年5月17日 更新者:Diana C Sanchez-Ramirez, PhD、University of Manitoba

Using Technology to Engage Patients With Interstitial Lung Disease (ILD) in a Home a Home Exercise Program.

Design: this pilot-study uses a two-group random assignment pretest-posttest design. Once the groups are being selected an envelope will be mailed to the participant with the printed version of the exercise program and surveys, a portable SpiroBank Smart FN multi parameter spirometer (MIR), a finger pulse oximeter (LOOKEE), a diary, and a prepaid envelop for a subsequent post-intervention return of the equipment and surveys and the diary.

Intervention: A) Exercise program: evidence-based and user friendly educational materials with recommendations on breathing and physical exercises will be developed. B) Patients intake: in a zoom meeting, a registered therapist (Pl) in charge of implementing the intervention will request informed consent to participate in the study, explain specifics of the intervention to each participant, and will conduct an initial assessment. C) Intervention (8 weeks): using the participants' initial assessment and personal characteristics, the therapist will provide personalized recommendations (e.g. maximum heart rate, minimum Sp02), explain the educational materials, and instruct patients on safety precautions (how to pace themselves, when to seek professional or emergency care). All participants (and immediate caregiver I necessary) will receive training: 1) basic device management (join a zoom meeting, watch a YouTube video), 2) use of the portable spirometer and its associated app, 3) use of finger pulse oximeter and 4) recording of the values in a dairy. Group one: will be asked to follow the exercise program with a small group of peers (2 groups/6 participants each) in a zoom meeting 3 times a week/45 min each {including 5 min before and 10 min after the meeting for free talk-chat between the participants e.g. questions, perceptions, etc.). The therapist will lead the first three meetings, gradually encourage participants to take turns leading the exercises with the goal of identifying /empowering potential patient leaders. Beginning with the fourth meeting, participants will be encouraged to connect to the meeting and follow their exercise program on their own, taking into account their individualized recommendations. The RA will organize and attend the zoom meetings to resolve general questions (e.g. equipment, platforms, etc.) and will act as a direct point of contact between the therapist and the participants. Group two: will be asked to follow the exercise program 3 times a week/30 min each while watching a pre-recorded YouTube video. D) Self-monitoring: patients will be asked to wear the finger pulse oximeter at all times while exercising, so that they can control their pace while avoiding exceeding target values (HR, Sp02). They will be asked to record in their HR and Sp02 values before and after participation in every session of the exercise program in a diary. E) Support: participants will be able to contact the therapist at any time during the study if they have questions or concerns. Otherwise, they will receive a follow-up phone call once a week from the RA.

研究概览

研究类型

介入性

注册 (实际的)

14

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

    • Manitoba
      • Winnipeg、Manitoba、加拿大、R3E 0T6
        • U of Manitoba

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:

  • Clinical diagnosis of interstitial lung disease
  • Access to a smart phone or tablet and home internet

Exclusion Criteria:

  • Acute exacerbation of their ILDs condition
  • History of neurological disease or mental illness
  • Inability to ambulate independently without supervision
  • Inability to complete basic tasks on a smart phone or tablet

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:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 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:小组缩放会议
第一组:将被要求与一小群同伴(2 组/每组 6 名参与者)一起参加 Zoom 会议,每周 3 次/每次 45 分钟(包括会议前 5 分钟和会议后 10 分钟免费)参与者之间的交谈 问题、看法等)。
Intervention (8 weeks): using the participants' initial assessment and personal characteristics, the therapist will provide personalized recommendations (e.g. maximum heart rate, minimum SpO2), explain the educational materials, and instruct patients on safety precautions. All participants (and immediate caregiver if necessary) will receive training in: 1) basic device management (join a zoom meeting, watch a YouTube video), 2) use of the portable spirometer and its associated app, 3) use of finger pulse oximeter and 4) recording of the values in a dairy.
实验性的:YouTube 预先录制的视频
第二组:将被要求每周 3 次/每次 30 分钟,同时观看预先录制的 YouTube 视频。
Intervention (8 weeks): using the participants' initial assessment and personal characteristics, the therapist will provide personalized recommendations (e.g. maximum heart rate, minimum SpO2), explain the educational materials, and instruct patients on safety precautions. All participants (and immediate caregiver if necessary) will receive training in: 1) basic device management (join a zoom meeting, watch a YouTube video), 2) use of the portable spirometer and its associated app, 3) use of finger pulse oximeter and 4) recording of the values in a dairy.

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
肺活量变化
大体时间:8周
将在干预前后使用 SpiroBank Smart F/V 多参数肺活量计 (MIR) 对其进行评估,中间每周一次以监测变化。 这款便携式肺活量计已通过 MDSAP 批准并符合 ATS/ERS 指南,可通过蓝牙自动连接到 iOS 和 Android 兼容应用程序 (MIR Spirobank)。 它通过智能手机上的消息和动画提供实时反馈,以提高测试期间的个人依从性。 该应用程序可以生成测试结果 PDF 打印输出,其中包含有关 19 个肺活量参数的信息。
8周
疲劳的变化
大体时间:8周
疲劳严重程度量表(0 -7“更高更差”)将用于衡量疲劳的严重程度。
8周
运动能力的变化
大体时间:8周
通过一分钟坐立测试(人们在一分钟内完成任务的次数)进行评估。
8周
运动后饱和度的变化
大体时间:8周
SpO2 将使用数字指尖脉搏血氧计在一分钟坐立测试前后进行测量。
8周
Change in dyspnea
大体时间:8 weeks
Modified Borg Scale (0 "none" to 10 "maximum") will be used to assess dyspnea.
8 weeks
Change in physical function
大体时间:8 weeks
Assessed using the EQ-5D-5L scale (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) (0-100 higher better function).
8 weeks
Changes in health-related quality of life (HRQoL)
大体时间:8 weeks
Assessed with the King's Brief Interstitial Lung Disease (KBILD), which is an ILD-specific measure of HRQoL. Total score ranges are 0-100 (100 represents best HRQoL).
8 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。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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9月1日

初级完成 (实际的)

2021年12月17日

研究完成 (实际的)

2022年5月17日

研究注册日期

首次提交

2021年6月15日

首先提交符合 QC 标准的

2021年6月22日

首次发布 (实际的)

2021年7月1日

研究记录更新

最后更新发布 (实际的)

2022年5月18日

上次提交的符合 QC 标准的更新

2022年5月17日

最后验证

2022年5月1日

更多信息

与本研究相关的术语

其他研究编号

  • HS24936 (B2021:051)

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

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