Fatigue in Long COVID
ConditionLong COVID
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMcMaster University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Lightning Process
BehavioralLP 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 Pacing
Other interventionActivity 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Lightning ProcessExperimental treatment 1 intervention
Group B: Activity pacingActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
12 monthsSecondary outcomes
1
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.
Time frame
6 months, 9 months, and 12 months2
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.
Time frame
Baseline, 6 months, 9 months, and 12 months3
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.
Time frame
6 months, 9 months, and 12 months4
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.
Time frame
6 months and 9 monthsLocations
Sponsors and contacts
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McMaster University
Lead sponsor
Hamilton Academic Health Sciences Organization
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: