Home-based Exercise Training for COPD Patients (HOMEX-1)
2021年12月23日 更新者：University of Zurich
Effects of a Long-term Home-based Exercise Training Program Using Minimal Equipment vs. Usual Care in COPD Patients: a Multicenter Randomized Controlled Trial
The aim of this study is to assess the effectiveness of a home-based exercise training program in COPD patients who have completed a pulmonary rehabilitation.
研究概览
详细说明
Exercise training is an important component of the management of chronic obstructive pulmonary disease (COPD) and numerous trials have shown large improvements in health-related quality of life (HRQoL) and exercise capacity in persons with COPD. However, the great majority of patients who would benefit from pulmonary rehabilitation (PR) never follow such a program. Moreover, many COPD patients are either not instructed to exercise at all or fail to adhere to exercise training at home after completing pulmonary rehabilitation.
This study evaluates an exercise training program that requires minimal equipment (i.e., only a chair and elastic bands) and can be easily implemented long-term in the patient's home-setting.
研究类型
介入性
注册 (实际的)
123
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
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Barmelweid、瑞士、5017
- Klinik Barmelweid
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Heiligenschwendi、瑞士、3625
- Berner Reha Zentrum AG
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Wald、瑞士、8636
- Zürcher RehaZentren Wald
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Winterthur、瑞士、8401
- Kantonsspital Winterthur
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Zurich、瑞士、8001
- University of Zurich
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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
40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:
- Signed informed consent after being informed
- Diagnosis of COPD, defined as forced expiratory volume in 1s/forced vital capacity (FEV1/FVC)<70% predicted, FEV1<80 % predicted after bronchodilation, with or without chronic symptoms (cough, sputum production) corresponding to a GOLD stage II-IV
- Completion of an inpatient or outpatient pulmonary rehabilitation not longer than 1 months ago
- Male and female patients ≥40 years of age
- Knowledge of German language to understand study material and assessments
Exclusion Criteria:
- Patients not able to conduct the exercise training program due to physical, cognitive or safety reasons, as judged by investigator; e.g., lower limb joint surgery within preceding 3 months, unstable cardiac disease, predominant neurological limitations.
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：其他
- 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 |
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实验性的：Exercise intervention
Home-based, minimal equipment exercise training program.
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基于家庭的运动训练计划，只需要最少的设备，并根据参与者的运动水平进行个性化调整（每周 6 次；15-20 分钟；38 张运动卡和一本交互式训练议程手册）。
随机分组后，医疗保健专业人员（HOMEX 教练）将在家中拜访干预组参与者，以设置培训地点、指导练习并建立个性化目标。
计划在 3 周和 8-9 周后进行随访。
同一位 HOMEX 教练将定期进行电话通话，以激励患者，讨论培训进度和具体的好处和障碍，并调整目标和培训计划。
其他干预因素是亲戚或朋友作为“陪练”伙伴参与以支持参与者。
全科医生被告知他/她的患者参与干预的情况。
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无干预：Control
Usual care (study participation does not have any impact on regular treatment or treatment decisions, including participation in other exercise training programs or rehabilitation programs)
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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 |
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Dyspnea
大体时间：Change from baseline to 12 months
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Dyspnea domain of the Chronic Respiratory Questionnaire (CRQ); 5 questions; 7-point Likert-type scale ranging from 1 (most severe dyspnea) to 7 (no dyspnea)
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Change from baseline to 12 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Dyspnea
大体时间：Change from baseline to 3, 6 and 12 months
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Dyspnea domain of the Chronic Respiratory Questionnaire (CRQ); 5 questions; 7-point Likert-type scale ranging from 1 (most severe dyspnea) to 7 (no dyspnea)
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Change from baseline to 3, 6 and 12 months
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Exercise capacity
大体时间：Change from baseline to 12 months
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Six-Minute Walk Test (walk distance) and 1-min Sit-to-Stand Test (number of repetitions) |
Change from baseline to 12 months
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Health-related quality of life
大体时间：Change from baseline to 12 months
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Chronic Respiratory Questionnaires (CRQ): Fatigue, emotional function, mastery domain and EuroQoL (EQ-5D-5L): 5 Dimensions - Mobility, self-care, usual activities, pain/discomfort, anxiety/depression including 1 item each with 5 levels
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Change from baseline to 12 months
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Health status
大体时间：Change from baseline to 12 months
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Visual analogue scale "Feeling thermometer" (0-100 scale; 0= "worst health you can imagine"; 100="best health you can imagine")
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Change from baseline to 12 months
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Exacerbations
大体时间：During entire study, assessed at 12 months
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Event based, patient reported
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During entire study, assessed at 12 months
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Symptoms
大体时间：Change from baseline to 12 months
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Questionnaire, COPD Assessment Test
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Change from baseline to 12 months
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
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遵守运动训练计划
大体时间：干预组参与者在 12 个月内每天进行评估
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基于培训日志的已完成培训课程的百分比
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干预组参与者在 12 个月内每天进行评估
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Satisfaction with the exercise training program
大体时间：From baseline to 12 months
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Questionnaire (Likert-Type scales)
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From baseline to 12 months
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Experience with the exercise training program
大体时间：From baseline to 12 months (assessed at 12 months)
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Semi-structured interview
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From baseline to 12 months (assessed at 12 months)
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Health professionals' feedback
大体时间：Assessed at 12 months
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Semi-structured interview
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Assessed at 12 months
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Cost effectiveness
大体时间：From baseline to 12 months (assessed at 3, 6, 12 months)
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Questionnaire: cost per quality-adjusted life year
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From baseline to 12 months (assessed at 3, 6, 12 months)
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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
- Frei A, Radtke T, Dalla Lana K, Brun P, Sigrist T, Spielmanns M, Beyer S, Riegler TF, Busching G, Spielmanns S, Kunz R, Cerini T, Braun J, Tomonaga Y, Serra-Burriel M, Polhemus A, Puhan MA. Effectiveness of a Long-term Home-Based Exercise Training Program in Patients With COPD After Pulmonary Rehabilitation: A Multicenter Randomized Controlled Trial. Chest. 2022 Dec;162(6):1277-1286. doi: 10.1016/j.chest.2022.07.026. Epub 2022 Aug 8.
- Frei A, Radtke T, Dalla Lana K, Braun J, Muller RM, Puhan MA. Effects of a long-term home-based exercise training programme using minimal equipment vs. usual care in COPD patients: a study protocol for two multicentre randomised controlled trials (HOMEX-1 and HOMEX-2 trials). BMC Pulm Med. 2019 Mar 1;19(1):57. doi: 10.1186/s12890-019-0817-7.
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)
2018年1月24日
初级完成 (实际的)
2020年3月20日
研究完成 (实际的)
2021年9月15日
研究注册日期
首次提交
2018年2月6日
首先提交符合 QC 标准的
2018年3月5日
首次发布 (实际的)
2018年3月12日
研究记录更新
最后更新发布 (实际的)
2021年12月27日
上次提交的符合 QC 标准的更新
2021年12月23日
最后验证
2021年12月1日
更多信息
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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