Fatigue in Long COVID

The COVID‐19 pandemic presented an unprecedented global health crisis, affecting millionsglobally and causing significant health and economic consequences. Although most peoplerecover from acute SARS‐CoV‐2 infection, a substantial minority, approximately 6 to 15%,develop persistent symptoms that last for months and impair daily function, commonlyreferred to as post‐COVID‐19 condition or long COVID. Common symptoms of long COVIDinclude fatigue, myalgia, dyspnea, sleep disturbance, and cognitive dysfunction ("brainfog"). The prevalence of long COVID is difficult to establish because most symptoms arenonspecific and many data sources rely on study designs that cannot confidently attributesymptoms to prior SARS‐CoV‐2 infection. Despite this uncertainty, converging evidencepoints to a large global burden, with >65 million people estimated to be living withfunctional limitations attributed to long COVID. The Lightning Process (LP), is amind‐body training program that is hypothesized to help individuals to develop aconscious influence on their level of functioning, using practical tools such asdiscussion, gentle movement and meditation‐like techniques. Emerging evidence suggeststhat gradually re‐engaging long COVID patients in physical activation and modifyingunhelpful beliefs may promote recovery. There are currently no established treatments forlong COVID, and patients often use activity pacing to manage their symptoms. The purposeof this trial is to establish the efficacy and safety of LP vs. activity pacing in adultsliving with long COVID. We hypothesize that in our trial, people randomized to LP willreport greater improvement in fatigue compared to those receiving activity pacing. Ourtrial will enroll people living with long COVID who are motivated and show willingness tochange their condition through intervention. The trial will assess whether, among adultsliving with long COVID (post COVID‐19 condition) and persistent, function limitingsymptoms, LP improves fatigue and other patient important outcomes, compared to activitypacing.The primary objective is to assess the effect of LP vs. activity pacing on fatigue amongadults 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 eventsBoth LP and pacing interventions span 26 weeks. Patients assigned to the LP interventionwill complete a brief preparatory phase, then attend three consecutive core sessions. TheLP 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‐fourweekly sessions, then sessions every two weeks until week 26.Participants will complete outcome measures at 6 months, coinciding with the immediatethe end of the intervention, and at 9 and 12 months. The post‐treatment time pointestimates 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.