Long COVIDFALCONNCT07697261
Fatigue in Long COVID
A study testing Lightning Process and Activity Pacing in people with Long COVID, run by McMaster University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Long COVID
- What is being tested?
- Lightning Process and Activity Pacing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Rozina Thobani, MSc contact
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Long COVID
- Being tested
- Lightning Process, Activity Pacing
- Keywords
- long COVID, Lightning Process, activity pacing, post-exertional malaise, fatigue
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lightning ProcessBehavioural
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.
Activity PacingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Lightning Process | Experimental | Lightning Process is a mind body intervention that focusses on identifying and interrupting negative thoughts that may affect fatigue. Receives: Behavioral: Lightning Process |
| Activity pacing | Active comparator | 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. Receives: Other: Activity Pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue (Checklist Individual Strength-Fatigue)
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.
Measured: 12 months
Secondary outcomes (10)
Respiratory function (Dyspnea-12)
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.
Measured: 6 months, 9 months, and 12 months
Post Exertional Malaise (De Paul Symptom Questionnaire)
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.
Measured: Baseline, 6 months, 9 months, and 12 months
Daily Pain (Brief Pain Inventory Short Form)
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.
Measured: 6 months, 9 months, and 12 months
Fatigue (Checklist Individual Strength-Fatigue)
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.
Measured: 6 months and 9 months
Physical function (SF-12)
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.
Measured: Baseline, 6 months, 9 months, and 12 months
Health related quality of life (EuroQol-5 Dimensions)
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.
Measured: Baseline, 6 months, 9 months, and 12 months
Severity of somatic symptoms (Patient Health Questionnaire-15)
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.
Measured: 6 months, 9 months, and 12 months
Functional impairment (Work and Social Adjustment Scale)
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.
Measured: 6 months, 9 months, and 12 months
Adverse Events (AEs)
To ensure participant safety, adverse events (AEs) will be documented at each follow-up visit.
Measured: Up to 12 months
Serious Adverse Events (SAEs)
To ensure participant safety, serious adverse events (SAEs) will be documented at each follow-up visit.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study startNov 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVIDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a pragmatic, multicenter, decentralized, international, parallel group, open-label randomized controlled trial. Participants living with long COVID will be randomized to receive either Lightning Process or activity pacing.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Hamilton Academic Health Sciences Organization
- Responsible party
- Principal investigator, Jason Busse, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07697261
- Sponsor's protocol ID
- Project ID-20247
- Acronym
- FALCON
- Status last verified
- Jul 2026
- First submitted
- 25 Jun 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fatigue in Long COVID Managed With Conservative Care: An International, Randomized Controlled Trial (FALCON Trial)
- ClinicalTrials.gov ID
- NCT07697261
- Acronym / sponsor ID
- FALCON / Project ID-20247
- Conditions
- Long COVID
- Keywords
- long COVID, Lightning Process, activity pacing, post-exertional malaise, fatigue
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Hamilton Academic Health Sciences Organization
- Study start
- Nov 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This will be a pragmatic, multicenter, decentralized, international, parallel group, open-label randomized controlled trial. Participants living with long COVID will be randomized to receive either Lightning Process or activity pacing.
| Arm | Type | Receives |
|---|---|---|
| Lightning Process | Experimental | Behavioral: Lightning ProcessLightning Process is a mind body intervention that focusses on identifying and interrupting negative thoughts that may affect fatigue. |
| Activity pacing | Active comparator | Other: Activity PacingActivity pacing is a self-management strategy that balances activity and rest to manage fatigue, allowing individuals to maintain consistent energy levels throughout the day. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The inclusion criteria for participants are:
Key exclusion criteria (7 listed)
- The exclusion criteria are:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lightning ProcessLP 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. | Behavioural | Lightning Process |
| Activity PacingActivity 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. | Other | Activity pacing |
Primary outcome
Fatigue (Checklist Individual Strength-Fatigue)
Time frame: 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.
10 secondary outcomes
Respiratory function (Dyspnea-12)
Time frame: 6 months, 9 months, and 12 months
Post Exertional Malaise (De Paul Symptom Questionnaire)
Time frame: Baseline, 6 months, 9 months, and 12 months
Daily Pain (Brief Pain Inventory Short Form)
Time frame: 6 months, 9 months, and 12 months
Fatigue (Checklist Individual Strength-Fatigue)
Time frame: 6 months and 9 months
Physical function (SF-12)
Time frame: Baseline, 6 months, 9 months, and 12 months
Health related quality of life (EuroQol-5 Dimensions)
Time frame: Baseline, 6 months, 9 months, and 12 months
Severity of somatic symptoms (Patient Health Questionnaire-15)
Time frame: 6 months, 9 months, and 12 months
Functional impairment (Work and Social Adjustment Scale)
Time frame: 6 months, 9 months, and 12 months
Adverse Events (AEs)
Time frame: Up to 12 months
Serious Adverse Events (SAEs)
Time frame: Up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Long COVID
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingPhase 2
SARS-CoV-2 and Herpesvirus Inhibition for Ending Long COVID Dysfunction
Post-acute Sequelae of COVID-19, Long COVID
Enrolling by invitation
Fareon Open Label Device Clinical Trial
Cognitive Dysfunction, Acquired Brain Injury
Not yet recruitingPhase 2
Study of VYD2311 for the Treatment of Adults With Long-COVID or Post-Vaccination Syndrome
Long COVID, COVID-19 (SARS-CoV-2 Infection)
Enrolling by invitationPhase 2
Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2
Systemic Inflammation, Neuroinflammation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rozina Thobani, MSc contact
Questions about this trial
What is this clinical trial studying?
A study testing Lightning Process and Activity Pacing in people with Long COVID, run by McMaster University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Jason Busse, PhD, Professor ((905) 525-9140, bussejw@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue (Checklist Individual Strength-Fatigue) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.