About 10-20% of persons who contract SARS CoV-2 will experience persistent post-acutesequelae of SARSCoV-2 infection (referred here as PASC). While treatments offered atemerging outpatient COVID recovery clinics are being informed by previous similardiseases, the need is great for a better understanding of the unique needs of thisgrowing population and for tested, efficacious rehabilitation programs to address them.We provide both here.The targeted six-week program will be comprised of a core set oftherapies, including individually titrated stretching and flexibility, strengthening ofaccessory breathing muscles and diaphragm, resistance and aerobic conditioning, andvestibular rehabilitation, supplemented by neuropsychological and cognitive remediationtailored to patients' needs.
About 10-20% of persons who contract SARS CoV-2 will experience persistent post-acute
sequelae of SARSCoV-2 infection (referred here as PASC). Given that persistent symptoms
are heterogeneous with multisystem involvement, recent consensus recommendations suggest
that a holistic rehabilitation program may be required to manage PASC and restore
function. While treatments offered at emerging outpatient COVID recovery clinics are
being informed by previous similar diseases, the need is great for a better understanding
of the unique needs of this growing population and for tested, efficacious rehabilitation
programs to address them. We provide both here. Specifically, our aims are: (1) To
quantify the incidence and severity of PASC across different variants and their effects
on health and functioning; (2) To develop and evaluate the effectiveness of a
patient-centered, interdisciplinary, multimodal comprehensive rehabilitation program
among patients with PASC; and (3)To estimate the costs associated with the proposed PASC
rehabilitation intervention and to examine the relationship between intervention's costs
and effectiveness and their implication for rehabilitation program initiatives. Data from
a large and diverse ongoing longitudinal survey of persons who tested for COVID-19 at the
study health system will serve as the sampling frame from which to identify and enroll
PASC patients in the study. The targeted six-week program will be comprised of a core set
of therapies, including individually titrated stretching and flexibility, strengthening
of accessory breathing muscles and diaphragm, resistance and aerobic conditioning, and
vestibular rehabilitation, supplemented by neuropsychological and cognitive remediation
tailored to patients' needs. Using a randomized controlled trial (RCT) design, the
effectiveness of the intervention will be compared to that of usual care augmented by a
onetime in-person assessment and patient education materials. In addition to walking
speed, a widely used global measure of aerobic capacity and endurance, and
patient-reported health and functioning (primary outcomes), we will assess the
intervention effectiveness on: (i) cognitive functioning, (ii) pain, (iii) fatigue, (iv)
tension, stress, anxiety, and depression, and (v) self-management of PASC symptoms
(secondary outcomes). Outcomes will be measured at fixed points in time at 8 weeks
(shortly after therapy completion) and at 90 day's post- study entry to examine
sustainability of effects. Our overarching hypothesis is that that higher intervention
costs in the intervention group will be more than offset by greater improvements in
outcomes implying that, overall, persons in the intervention group will receive more
cost-effective care than those in usual care group. Given the dearth of rigorous
scientific evidence regarding effective assessment and treatment of PASC and the
unresolved questions concerning access to and value of post-COVID rehabilitation care,
the results of this study will have significant implications for both policy and program
development.
Other: Comprehensive Rehabilitation
Subjects will be given the option to undergo the comprehensive rehabilitation program
including speech therapy and physical therapy. Progression through the rehabilitation
program will be personalized and designed based on impairments identified during the
comprehensive baseline assessment and previous sessions. Subjects will undergo 12 one-
hour sessions over the course of six weeks. The exercise program will be graded and
targeted to the person's physical capacity with the goal of slowly advancing the exercise
duration or intensity to effect physiological strengthening and increased physical
function.
Other: Augmented Usual Care
Following randomization, subjects in the augmented usual care group will be given the
results of their in-person baseline assessment as well as the WHO Guide "Support for
Rehabilitation Self-Management after COVID-19 Related Illness." This guide consists of
ways to manage: breathlessness, difficulty with voice, eating, drinking and swallowing;
problems with attention, memory and thinking clearly; limitations in activities of daily
living, manage stress and mood dysfunction and advice for when to contact healthcare
professionals. Follow-up interviews will assess process measures, including use of
outpatient rehabilitation clinics, to examine possible contamination effects
Inclusion Criteria:
- 18 years if age or older
- English or Spanish speaking
- Previously tested positive for COVID
- Still having symptoms not explained by any other etiologies
- Cognitive impairment
- Fatigue
Exclusion Criteria:
- Participation in another clinical trial
- Score greater than 12 on the fatigue scale
- Score greater than 30 on the memory/thinking scale
- Severe cognitive impairment (i.e. Alzheimer's, Dementia)
- Mental or physical inability to participate in the program
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Timothy Dillingham, MD, MS, Principal Investigator
University of Pennsylvania