Rehabilitation Program for Long COVID

Overseen By Benjamin Abramoff, MD, MS

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Alzheimer's, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 6 weeks

216 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Comprehensive Rehabilitation for Long COVID?

Research shows that comprehensive rehabilitation, which includes exercise and other therapies, can help improve breathing, physical fitness, and overall recovery in patients with long COVID. Studies have found improvements in symptoms like breathlessness and fatigue, as well as better functional outcomes in patients who underwent rehabilitation programs. ^{1 2 3 4 5}

How does the Comprehensive Rehabilitation treatment for Long COVID differ from other treatments?

The Comprehensive Rehabilitation treatment for Long COVID is unique because it involves a multidisciplinary approach that includes physical training, education, and group psychotherapy, which helps improve physical capacity and reduce symptoms like breathlessness. This holistic approach is tailored to address the diverse and persistent symptoms of long COVID, unlike other treatments that may focus on single aspects of recovery. ^{6 7 8 9 10}

What is the purpose of this trial?

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.

Research Team

Timothy Dillingham, MD, MS

Principal Investigator

University of Pennsylvania

Eligibility Criteria

This trial is for adults over 18 who previously tested positive for COVID-19 and are still experiencing symptoms like cognitive impairment or fatigue that can't be explained by other conditions. Participants must speak English or Spanish.

Inclusion Criteria

I have difficulty with memory or thinking clearly.

You have had a positive COVID test in the past.

I have symptoms that other conditions don't explain.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a comprehensive rehabilitation program including speech therapy and physical therapy, with 12 one-hour sessions over six weeks.

6 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with outcomes measured at 8 weeks and 90 days post-study entry.

12 weeks

Treatment Details

Interventions

• Comprehensive Rehabilitation

Trial Overview The study tests a six-week comprehensive rehabilitation program against usual care to improve functioning in individuals with Long COVID Syndrome. The program includes exercises, breathing muscle strengthening, conditioning, and tailored cognitive therapy.

Participant Groups

Group I: Comprehensive Rehabilitation Experimental Treatment 1 Intervention

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.

Group II: Augmented Usual Care Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Medical College of Wisconsin

Collaborator

Trials

645

Recruited

1,180,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Findings from Research

The COVID-Rehab study aims to evaluate the effectiveness of an eight-week cardiopulmonary rehabilitation program on improving cardiorespiratory fitness in 40 individuals suffering from long COVID-19, with assessments on various health aspects including quality of life and cognitive function.

This randomized clinical trial will compare a structured exercise program against a control group maintaining their usual habits, addressing the lack of specific rehabilitation guidelines for long COVID-19 patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiopulmonary Rehabilitation in Long-COVID-19 Patients with Persistent Breathlessness and Fatigue: The COVID-Rehab Study. Besnier, F., Bérubé, B., Malo, J., et al.[2022]

A multidisciplinary rehabilitation program for 97 patients with long COVID-19 led to significant improvements in body composition, including a reduction in abdominal fat and an increase in skeletal muscle mass after 6 weeks.

Almost 80% of participants reported improved breathing, and their physical capacity significantly increased, as shown by tests like the 6 Minute Walking Test, indicating the program effectively enhanced overall health and functionality in long COVID-19 patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Multidisciplinary Rehabilitation Program in Patients with Long COVID-19: Post-COVID-19 Rehabilitation (PCR SIRIO 8) Study. Ostrowska, M., Rzepka-Cholasińska, A., Pietrzykowski, Ł., et al.[2023]

References

1. Korea (South) pubmed.ncbi.nlm.nih.gov

Comprehensive Rehabilitation in Severely Ill Inpatients With COVID-19: A Cohort Study in a Tertiary Hospital. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Cardiopulmonary Rehabilitation in Long-COVID-19 Patients with Persistent Breathlessness and Fatigue: The COVID-Rehab Study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Description and Functional Outcomes of a Novel Interdisciplinary Rehabilitation Program for Hospitalized Patients With COVID-19. [2023]

4. Spain pubmed.ncbi.nlm.nih.gov

[Rehabilitation and COVID disease: characterization and follow-up of hospitalized patients in Granada, Spain]. [2022]

5. India pubmed.ncbi.nlm.nih.gov

Supervised hospital based pulmonary rehabilitation outcome in long COVID-experience from a tertiary care hospital. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical Features and Paraclinical Findings in Patients with SARS CoV-2 Pneumonia and the Impact of Pulmonary Rehabilitation on the Instrumental Activities of Daily Living in POST-COVID-19 Patients. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Accessing Care Services for Long COVID Sufferers in Alberta, Canada: A Random, Cross-Sectional Survey Study. [2023]

8. India pubmed.ncbi.nlm.nih.gov

General rehabilitation for the Post-COVID-19 condition: A narrative review. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of Multidisciplinary Rehabilitation Program in Patients with Long COVID-19: Post-COVID-19 Rehabilitation (PCR SIRIO 8) Study. [2023]

10. Italy pubmed.ncbi.nlm.nih.gov

Long-term outcomes of different rehabilitation programs in patients with long COVID syndrome: a cohort prospective study. [2023]