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Fatigue in Long COVID (FALCON)

7 juli 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

100

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Dr. Jason Busse, PhD, Professor
  • Telefoonnummer: (905) 525-9140
  • E-mail: bussejw@mcmaster.ca

Studie Contact Back-up

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Lightning Process
Lightning Process is a mind body intervention that focusses on identifying and interrupting negative thoughts that may affect fatigue.
Gedragsmatig: 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.
Actieve vergelijker: 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.
Ander: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Fatigue (Checklist Individual Strength-Fatigue)
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Respiratory function (Dyspnea-12)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: Up to 12 months
To ensure participant safety, serious adverse events (SAEs) will be documented at each follow-up visit.
Up to 12 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

McMaster University

Medewerkers

Hamilton Academic Health Sciences Organization

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 november 2026

Primaire voltooiing (Geschat)

1 december 2028

Studie voltooiing (Geschat)

1 december 2028

Studieregistratiedata

Eerst ingediend

25 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

7 juli 2026

Eerst geplaatst (Werkelijk)

13 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

13 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

7 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • Project ID-20247

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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-tijdsbestek voor delen

The study protocol will be publicly available upon study commencement.

IPD-toegangscriteria voor delen

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 delen Ondersteunend informatietype

  • LEERPROTOCOOL

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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