Evaluating a Comprehensive Multimodal Outpatient Rehabilitation Program for PASC Program to Improve Functioning of Persons Suffering From Post-COVID-19 Syndrome: A Randomized Controlled Trial

Not Applicable

• Conditions: Post-Acute COVID-19; Post-Acute COVID-19 Syndrome; Cognitive Impairment; Post-Acute COVID-19 Infection; Long COVID; Long Covid19; Dyspnea; Orthostasis

• Registration Number: NCT06156202
• Lead Sponsor: University of Pennsylvania

Brief Summary

About 10-20% of persons who contract SARS CoV-2 will experience persistent post-acute sequelae of SARSCoV-2 infection (referred here as PASC). 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.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.

Detailed Description

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.

Study Timeline

• Study Start: 2023-11-15
• Study First Submitted: 2023-11-28
• Study First Submitted QC: 2023-11-28
• Study First Posted: 2023-12-05
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-29
• Last Update Posted: 2025-01-30
• Primary Completion: 2025-09-30
• Study Completion: 2026-03-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 216

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Six minute walk test	At week 1 and week 8

Trial Locations

Locations (1)

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States