Fatigue in Long COVID Managed With Conservative Care: An International, Randomized Controlled Trial (FALCON Trial)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Fatigue (Checklist Individual Strength-Fatigue)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Due to the nature of the interventions under study, the trial is necessarily open-label. Blinding of participants, LP instructors and occupational therapists is not possible. The study team members responsible for data analysis and interpretation will remain blinded to treatment allocation until completion of the primary analyses and interpretation of results.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The inclusion criteria for participants are:
- •Adults aged 18 to 65 years
- •Meeting the WHO clinical case definition for long COVID and
- •Self-reported experiencing long COVID symptoms such as fatigue, muscle pain, and brain fog.
- •Reporting a minimum score of ≥35 on the Checklist Individual Strength CIS-fatigue domain.
- •Able to speak and read English
- •Scoring higher in contemplation, action or maintenance scores than the precontemplation phase on the readiness to change questionnaire
- •Provides consent for study participation.
- •Consistent access to an internet-connected device (e.g., smartphone, tablet, laptop) that can facilitate access to the study interventions.
排除标准
- •The exclusion criteria are:
- •Long COVID participants whose presentation is primarily restricted to anosmia.
- •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.
- •Participants who will not be able to attend intervention sessions or follow up visits due to anticipated significant life changes or relocation.
- •Unable to provide informed consent (e.g. cognitive disability, language barrier)
- •Co-morbidities that likely to impair function for as long or longer than long COVID
- •Current participation in psychotherapy, structured physical rehabilitation (e.g., physiotherapy or occupational therapy), or another trial that does not permit co-enrollment.
研究组 & 干预措施
Lightning Process
Lightning Process is a mind body intervention that focusses on identifying and interrupting negative thoughts that may affect fatigue.
干预措施: Lightning Process (Behavioral)
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.
干预措施: Activity Pacing (Other)
结局指标
主要结局
Fatigue (Checklist Individual Strength-Fatigue)
时间窗: 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.
次要结局
- Respiratory function (Dyspnea-12)(6 months, 9 months, and 12 months)
- Post Exertional Malaise (De Paul Symptom Questionnaire)(Baseline, 6 months, 9 months, and 12 months)
- Daily Pain (Brief Pain Inventory Short Form)(6 months, 9 months, and 12 months)
- Fatigue (Checklist Individual Strength-Fatigue)(6 months and 9 months)
- Physical function (SF-12)(Baseline, 6 months, 9 months, and 12 months)
- Health related quality of life (EuroQol-5 Dimensions)(Baseline, 6 months, 9 months, and 12 months)
- Severity of somatic symptoms (Patient Health Questionnaire-15)(6 months, 9 months, and 12 months)
- Functional impairment (Work and Social Adjustment Scale)(6 months, 9 months, and 12 months)
- Adverse Events (AEs)(Up to 12 months)
- Serious Adverse Events (SAEs)(Up to 12 months)
研究者
Jason Busse
Professor
McMaster University