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

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

• National Institutes of Health (NIH)

  collaborator NIH

• Medical College of Wisconsin

  collaborator OTHER

• University of Pennsylvania

  lead OTHER

Principal Investigators

• Timothy Dillingham, MD, MS · University of Pennsylvania

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-11-15

Primary Completion

2025-11-30

Completion

2025-11-30

Countries

• United States

Study Locations