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Fatigue in Long COVID (FALCON)

7. juli 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Antatt)

100

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Dr. Jason Busse, PhD, Professor
  • Telefonnummer: (905) 525-9140
  • E-post: bussejw@mcmaster.ca

Studer Kontakt Backup

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Lightning Process
Lightning Process is a mind body intervention that focusses on identifying and interrupting negative thoughts that may affect fatigue.
Atferdsmessig: 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.
Aktiv komparator: 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.
Annen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Fatigue (Checklist Individual Strength-Fatigue)
Tidsramme: 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

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

McMaster University

Samarbeidspartnere

Hamilton Academic Health Sciences Organization

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. november 2026

Primær fullføring (Antatt)

1. desember 2028

Studiet fullført (Antatt)

1. desember 2028

Datoer for studieregistrering

Først innsendt

25. juni 2026

Først innsendt som oppfylte QC-kriteriene

7. juli 2026

Først lagt ut (Faktiske)

13. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • Project ID-20247

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

The study protocol will be publicly available upon study commencement.

Tilgangskriterier for IPD-deling

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-deling Støtteinformasjonstype

  • STUDY_PROTOCOL

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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