此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Fatigue in Long COVID (FALCON)

2026年7月7日 更新者：Jason Busse、McMaster University

Fatigue in Long COVID Managed With Conservative Care: An International, Randomized Controlled Trial (FALCON Trial)

Long COVID affects about 6 in 100 people after a COVID-19 infection. It can cause ongoing problems like ongoing tiredness, muscle pain, and "brain fog." We know very little about which treatments might be helpful for long COVID.

The goal of this trial is to compare two treatments for people with long COVID to try to manage their symptoms. The main question is to assess whether the Lightning Process is effective for people living with long COVID compared to activity pacing. Each person will be placed into one of the two groups randomly (by chance, like flipping a coin). Activity pacing helps people balance rest and daily activities. The Lightning Process teaches ways to change thought patterns and body responses to symptoms. We will include 100 adults with long COVID. Everything will be done online, including filling out surveys about health and daily life. The goal is to find out which approach helps people feel better and improve their daily activities.

研究概览

地位

地位

指示当前招聘状态或扩展访问状态。
尚未招聘

条件

条件

正在研究的疾病、紊乱、综合征、疾病或损伤。在 ClinicalTrials.gov 上，条件还可能包括其他与健康相关的问题，例如寿命、生活质量和健康风险。

干预/治疗

干预/治疗

作为临床研究重点的过程或行动。干预措施包括药物、医疗设备、程序、疫苗和其他处于研究阶段或已经可用的产品。干预措施还可以包括非侵入性方法，例如教育或调整饮食和锻炼。

详细说明

The COVID-19 pandemic presented an unprecedented global health crisis, affecting millions globally and causing significant health and economic consequences. Although most people recover from acute SARS-CoV-2 infection, a substantial minority, approximately 6 to 15%, develop persistent symptoms that last for months and impair daily function, commonly referred to as post-COVID-19 condition or long COVID. Common symptoms of long COVID include fatigue, myalgia, dyspnea, sleep disturbance, and cognitive dysfunction ("brain fog"). The prevalence of long COVID is difficult to establish because most symptoms are nonspecific and many data sources rely on study designs that cannot confidently attribute symptoms to prior SARS-CoV-2 infection. Despite this uncertainty, converging evidence points to a large global burden, with >65 million people estimated to be living with functional limitations attributed to long COVID. The Lightning Process (LP), is a mind-body training program that is hypothesized to help individuals to develop a conscious influence on their level of functioning, using practical tools such as discussion, gentle movement and meditation-like techniques. Emerging evidence suggests that gradually re-engaging long COVID patients in physical activation and modifying unhelpful beliefs may promote recovery. There are currently no established treatments for long COVID, and patients often use activity pacing to manage their symptoms. The purpose of this trial is to establish the efficacy and safety of LP vs. activity pacing in adults living with long COVID. We hypothesize that in our trial, people randomized to LP will report greater improvement in fatigue compared to those receiving activity pacing. Our trial will enroll people living with long COVID who are motivated and show willingness to change their condition through intervention. The trial will assess whether, among adults living with long COVID (post COVID-19 condition) and persistent, function limiting symptoms, LP improves fatigue and other patient important outcomes, compared to activity pacing.

The primary objective is to assess the effect of LP vs. activity pacing on fatigue among adults with long COVID.

The secondary objectives are to assess the effect of LP vs. activity pacing on

  • Physical functioning
  • Pain severity
  • Post exertional malaise
  • Health related quality of life
  • Somatic symptom severity
  • Functional impairment
  • Respiratory function
  • Adverse events and serious adverse events

Both LP and pacing interventions span 26 weeks. Patients assigned to the LP intervention will complete a brief preparatory phase, then attend three consecutive core sessions. The LP protocol includes two follow-up calls one week apart and a booster call at week 26. Patients assigned to the pacing intervention complete 15 sessions over 24 weeks-four weekly sessions, then sessions every two weeks until week 26.

Participants will complete outcome measures at 6 months, coinciding with the immediate the end of the intervention, and at 9 and 12 months. The post-treatment time point estimates the proximal effect of LP compared to pacing, where contamination is lowest, co-interventions are least likely to diverge across arms, and any harms (e.g., post-exertional worsening) are most plausibly related to the assigned strategy.

研究类型

研究类型

描述临床研究的性质。研究类型包括介入性研究（也称为临床试验）、观察性研究（包括患者登记）和扩展访问。
介入性

注册 (估计的)

注册

临床研究的参与者人数。 “预期”入组人数是研究人员进行研究所需的目标参与者人数。
100

阶段

阶段

根据美国食品和药物管理局 (FDA) 制定的定义，研究药物或生物制品的临床试验阶段。阶段基于研究的目标、参与者的数量和其他特征。有五个阶段：早期第 1 阶段（以前列为第 0 阶段）、第 1 阶段、第 2 阶段、第 3 阶段和第 4 阶段。不适用用于描述没有 FDA 定义的阶段的试验，包括设备试验或行为干预。
  • 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。

学习联系方式

学习联系方式

可以回答临床研究注册问题的人员的姓名和联系信息。进行研究的每个地点也可能有特定的联系人，他们可能能够更好地回答这些问题。
  • 姓名：Dr. Jason Busse, PhD, Professor
  • 电话号码：(905) 525-9140
  • 邮箱：bussejw@mcmaster.ca

研究联系人备份

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

资格标准

想要参加临床研究的人必须满足的关键要求或他们必须具备的特征。资格标准包括纳入标准（一个人参与研究所必需的）和排除标准（阻止一个人参与）。资格标准的类型包括一项研究是否接受健康志愿者、是否有年龄或年龄组要求，或是否受性别限制。

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • The inclusion criteria for participants are:

    1. Adults aged 18 to 65 years
    2. Meeting the WHO clinical case definition for long COVID and
    3. Self-reported experiencing long COVID symptoms such as fatigue, muscle pain, and brain fog.
    4. Reporting a minimum score of ≥35 on the Checklist Individual Strength CIS-fatigue domain.
    5. Able to speak and read English
    6. Scoring higher in contemplation, action or maintenance scores than the precontemplation phase on the readiness to change questionnaire
    7. Provides consent for study participation.
    8. Consistent access to an internet-connected device (e.g., smartphone, tablet, laptop) that can facilitate access to the study interventions.

Exclusion Criteria:

  • The exclusion criteria are:

    1. Long COVID participants whose presentation is primarily restricted to anosmia.
    2. Participants with Post-Intensive Care Syndrome (PICS) or serious organic sequelae of COVID-19, such as structural lung injury attributable to mechanical ventilation or other organ damage requiring ongoing specialist management.
    3. Participants who will not be able to attend intervention sessions or follow up visits due to anticipated significant life changes or relocation.
    4. Unable to provide informed consent (e.g. cognitive disability, language barrier)
    5. Co-morbidities that likely to impair function for as long or longer than long COVID
    6. Current participation in psychotherapy, structured physical rehabilitation (e.g., physiotherapy or occupational therapy), or another trial that does not permit co-enrollment.

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

参与者组/臂

根据试验方案，接受特定干预/治疗或不接受干预的临床试验参与者组或亚组。
干预/治疗

干预/治疗

作为临床研究重点的过程或行动。干预措施包括药物、医疗设备、程序、疫苗和其他处于研究阶段或已经可用的产品。干预措施还可以包括非侵入性方法，例如教育或调整饮食和锻炼。
实验性的：Lightning Process
Lightning Process is a mind body intervention that focusses on identifying and interrupting negative thoughts that may affect fatigue.
行为的：Lightning Process
LP is a mind body intervention which is delivered over 3 consecutive days to individuals or in groups via video technology. The sessions are approximately 4 hours long. Experienced LP practitioners will deliver the LP intervention remotely and individually. The intervention is comprised of a preparation phase, core sessions, and follow-up. Preparation consists of an audio home-study module (about 4 hours total) and about 1 hour of preparatory coaching by telephone or videoconference in the days to weeks before delivery of the LP intervention to orient participants to the approach and address any questions.
有源比较器：Activity pacing
Activity pacing is a self-management strategy that balances activity and rest to manage fatigue, allowing individuals to maintain consistent energy levels throughout the day.
其他：Activity Pacing
Activity Pacing, a self-management strategy that balances activity and rest to manage fatigue, allowing individuals to maintain consistent energy levels throughout the day. The aim of activity pacing is to avoid symptom exacerbations whilst achieving as much as possible with limited energy. Pacing focusses on developing awareness not only of the symptoms but also more subtle indicators that herald a future exacerbation of symptoms (listening to your body) and becoming aware of effect of activity or lack of rest on disability. Senior occupational therapy students will deliver activity pacing remotely and individually by videoconference.

研究衡量的是什么？

主要结果指标

主要结果指标

在临床研究的方案中，对于评估干预/治疗的效果最重要的计划结果测量。大多数临床研究有一项主要结果指标，但有些研究有不止一项。
结果测量
措施说明
大体时间
Fatigue (Checklist Individual Strength-Fatigue)
大体时间：12 months
The primary outcome will be the mean change in fatigue scores between Lightning Process and activity pacing group at 12 months post randomization. This will be assessed on the fatigue domain of the 8-item Checklist Individual Strength (CIS-fatigue) at 12 months follow-up. The CIS-fatigue domain consists of 8 items with a total score ranging from 8 to 56, with higher scores indicating more severe fatigue.
12 months

次要结果测量

次要结果测量

在临床研究的方案中，计划的结果测量值在评估干预效果时不如主要结果测量值重要，但仍然值得关注。大多数临床研究有不止一项次要结果指标。
结果测量
措施说明
大体时间
Respiratory function (Dyspnea-12)
大体时间：6 months, 9 months, and 12 months
Change in respiratory functioning will be assessed with the Dyspnea-12 (D-12) Scale which measures the current level of a patient's breathlessness severity, incorporating both physical and affective aspects, and does not depend on activity limitation. Each item scored from 0-3, for a total score range of 0-36. Higher scores indicate worse dyspnea.
6 months, 9 months, and 12 months
Post Exertional Malaise (De Paul Symptom Questionnaire)
大体时间：Baseline, 6 months, 9 months, and 12 months
Change in post exertional malaise (PEM) will be measured using a brief questionnaire derived from De Paul Symptom Questionnaire (DSQ). It is a 5-item self-report tool that evaluates common symptoms of long COVID, including worsening after physical or mental activity, recovery duration and activity intolerance. Each item is scored 0-4 on 5-point Likert scale. A score of ≥2 for frequency and ≥2 for severity on any item suggests PEM.
Baseline, 6 months, 9 months, and 12 months
Daily Pain (Brief Pain Inventory Short Form)
大体时间：6 months, 9 months, and 12 months
Change in pain will be assessed using Brief Pain Inventory short form (BPI-SF). This is a 9-item questionnaire used to evaluate the severity of a patient's pain and the impact of their pain on daily functioning. The BPI-SF evaluates pain severity at its worst, least, and average during the previous week, as well as current pain level, with 0 representing no pain and 10 the worst pain imaginable.
6 months, 9 months, and 12 months
Fatigue (Checklist Individual Strength-Fatigue)
大体时间：6 months and 9 months
Change in fatigue scores will be measured at 6 and 9 months post randomization. This will be assessed on the fatigue domain of the 8-item CIS-fatigue scale at 6 and 9 months follow-up.
6 months and 9 months
Physical function (SF-12)
大体时间：Baseline, 6 months, 9 months, and 12 months
Change in physical functioning will be measured using Short Form Health Survey (SF-12) scale, a 12-item questionnaire that assesses physical and mental health status.
Baseline, 6 months, 9 months, and 12 months
Health related quality of life (EuroQol-5 Dimensions)
大体时间：Baseline, 6 months, 9 months, and 12 months
Health related quality of life will be measured using the EuroQol-5 Dimensions (EQ-5D) scale that provides a generic measure of health for clinical and economic appraisal. Its a continuous (scale 0-100). Higher scores relate to better health.
Baseline, 6 months, 9 months, and 12 months
Severity of somatic symptoms (Patient Health Questionnaire-15)
大体时间：6 months, 9 months, and 12 months
Change in somatic symptoms will be measured using Patient Health Questionnaire-15 (PHQ-15) that screens for somatization concerns and monitors symptom severity. Its a continuous (scale 0-30). Higher scores relate to greater somatic symptom severity.
6 months, 9 months, and 12 months
Functional impairment (Work and Social Adjustment Scale)
大体时间：6 months, 9 months, and 12 months
Change in functional impairment will be measured through Work and Social Adjustment Scale (WSAS) scale. Its a 5-item continuous scale (0-40) of functional impairment attributable to an identified problem. Higher scores relate to severely impaired.
6 months, 9 months, and 12 months
Adverse Events (AEs)
大体时间：Up to 12 months
To ensure participant safety, adverse events (AEs) will be documented at each follow-up visit.
Up to 12 months
Serious Adverse Events (SAEs)
大体时间：Up to 12 months
To ensure participant safety, serious adverse events (SAEs) will be documented at each follow-up visit.
Up to 12 months

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。

赞助

赞助

发起研究并有权和控制研究的组织或个人。
McMaster University

合作者

合作者

为临床研究提供支持的赞助商以外的组织。这种支持可能包括与资金、设计、实施、数据分析或报告相关的活动。
Hamilton Academic Health Sciences Organization

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 (估计的)

学习开始

第一位参与者参加临床研究的实际日期。 “预期”研究开始日期是研究人员认为将成为研究开始日期的日期。
2026年11月1日

初级完成 (估计的)

初级完成

临床研究的最后一名参与者接受检查或接受干预以收集主要结果测量的最终数据的日期。临床研究是否根据方案结束或被终止不影响该日期。对于具有多个不同完成日期的主要结果测量的临床研究，该术语是指完成所有主要结果测量的数据收集的日期。 “预期”主要完成日期是研究人员认为将成为研究主要完成日期的日期。
2028年12月1日

研究完成 (估计的)

研究完成

临床研究中最后一位参与者接受检查或接受干预/治疗以收集主要结局指标、次要结局指标和不良事件（即最后一位参与者的最后一次就诊）的最终数据的日期。 “预期”研究完成日期是研究人员认为将成为研究完成日期的日期。
2028年12月1日

研究注册日期

首次提交

首次提交

研究发起人或研究者首次向 ClinicalTrials.gov 提交研究记录的日期。在首次提交日期和记录在 ClinicalTrials.gov 上的可用性（首次发布日期）之间通常会有几天的延迟。
2026年6月25日

首先提交符合 QC 标准的

首先提交符合 QC 标准的

研究发起人或研究者首次提交符合国家医学图书馆 (NLM) 质量控制 (QC) 审查标准的研究记录的日期。在满足 NLM 的 QC 审查标准之前，发起人或研究者可能需要修改和提交研究记录一次或多次。申办者或研究者有责任确保研究记录符合 NLM QC 审查标准。
2026年7月7日

首次发布 (实际的)

首次发布

在国家医学图书馆 (NLM) 质量控制 (QC) 审查结束后，研究记录首次在 ClinicalTrials.gov 上可用的日期。研究发起人或研究者提交研究记录的日期与首次发布日期之间通常会有几天的延迟。
2026年7月13日

研究记录更新

最后更新发布 (实际的)

最后更新发布

在 ClinicalTrials.gov 上提供研究记录更改的最近日期。研究发起人或研究者向 ClinicalTrials.gov 提交变更的时间（最后更新提交日期）和最后更新发布日期之间可能会有延迟。
2026年7月13日

上次提交的符合 QC 标准的更新

上次提交的符合 QC 标准的更新

研究发起人或研究者提交符合国家医学图书馆 (NLM) 质量控制 (QC) 审查标准的研究记录更改的最近日期。申办者或研究者有责任确保研究记录符合 NLM QC 审查标准。
2026年7月7日

最后验证

最后验证

研究发起人或研究者确认 ClinicalTrials.gov 上的临床研究信息准确且最新的最近日期。如果一项研究的招募状态为招募；尚未招聘；或活跃，未在过去 2 年内确认招募，该研究的招募状态显示为未知。
2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

其他研究编号

由研究的发起人、资助者或其他人分配给临床研究的标识符或 ID 号，而不是 NCT 号。这些编号可能包括来自其他试验登记处的唯一标识符和美国国立卫生研究院的资助编号。
  • Project ID-20247

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

The study protocol will be published and publicly available. We will share the de-identified data with investigators who have ethics approval for the specific secondary analysis and sign a data sharing agreement. Due to privacy concerns, the complete data files will not be shared online.

IPD 共享时间框架

The study protocol will be publicly available upon study commencement.

IPD 共享访问标准

Anonymized data will be shared upon reasonable request from other researchers for use in specific research projects on long COVID when the main analyses are completed and published.

IPD 共享支持信息类型

  • 研究方案

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.

Cookie设置

我们使用cookie来确保我们在您的网站上给您最好的体验。有关更多详细信息，请仔细阅读我们的隐私和Cookie政策。...>>>您可以按照政策中的说明，随时通过从网站或计算机中删除Cookie来更改首选项或撤回您的同意。请接受它，然后在下面的“管理设置”部分中勾选相应的框，选择您的偏好。在继续使用本网站的任何部分之前，请仔细阅读我们的服务条款。
«管理设定