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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a comprehensive rehabilitation program designed to help people with Long COVID. It aims to improve breathing, flexibility, strength, and cognitive functions through a personalized six-week therapy plan. Participants will either receive usual care with self-management tips or participate in the full rehab program. The trial seeks individuals who have had COVID, continue to experience symptoms like fatigue or cognitive issues, and are interested in a structured recovery program.

As an unphased trial, this study offers a unique opportunity to contribute to understanding effective rehabilitation strategies for Long COVID.

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 prior data suggests that this rehabilitation program is safe for long COVID patients?

Research has shown that rehab programs are generally safe for people recovering from COVID-19. Studies have found that these programs can improve quality of life and reduce symptoms like tiredness, anxiety, and depression without causing serious side effects. Treatments include exercises tailored to individual needs, such as stretching, breathing exercises, and physical and speech therapy.

Participants in similar rehab programs have demonstrated positive results with few negative effects. The programs are carefully designed to match each person's physical ability, starting with easy exercises that become more challenging as strength increases.

In summary, rehab programs are well-tolerated and have a good safety record. They aid recovery from long COVID symptoms without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the comprehensive rehabilitation program for Long COVID because it offers a tailored approach that adapts to each patient's unique needs. Unlike standard care, which typically involves general advice and basic exercises, this program includes personalized speech and physical therapy sessions. Participants engage in 12 one-hour sessions over six weeks, with exercises specifically graded to their physical capacity, aiming to progressively increase their strength and function. By focusing on individualized treatment plans, this program holds promise for more effective recovery and improved quality of life for those dealing with Long COVID.

What evidence suggests that this trial's rehabilitation program could be effective for Long COVID?

Research has shown that rehabilitation programs can help people with Long COVID, also known as post-acute sequelae of SARS-CoV-2 infection (PASC). One study found that a 2- to 6-week outpatient rehabilitation program improved physical and mental functions in patients. In this trial, participants in the Comprehensive Rehabilitation arm will receive exercises and therapies tailored to individual needs, aiming to strengthen muscles, improve breathing, and boost overall health. Evidence indicates that this approach can enhance recovery by improving physical abilities and reducing symptoms. These programs are designed to gradually increase exercise levels, helping to improve strength and endurance over time. Meanwhile, participants in the Augmented Usual Care arm will receive guidance for self-management and follow-up support. ^{2 6 7 8 9}

Who Is on the Research Team?

Timothy Dillingham, MD, MS

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40894014/

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

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06156202

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

3. sciencedirect.com sciencedirect.com/science/article/pii/S0003999324007779

Long COVID (Post Acute Sequelae of SARS-CoV-2 ... To assess and report current effective treatments on clinical outcomes for adults with Long-COVID. Data Sources. We searched PubMed (NLM) from January 1 ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2828267

Brief Outpatient Rehabilitation Program for Post–COVID-19 ... This randomized clinical trial examines the effectiveness of a 2- to 6-week outpatient cognitive and behavioral rehabilitation program for individuals.

5. pandemicpact.org pandemicpact.org/grants/P36925

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

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11865788/

Rehabilitation interventions and outcomes for post-COVID ... Several rehabilitation interventions have been proposed to support people with post-COVID-19 condition (PCC). However, the full spectrum of ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10388602/

Long-term outcomes of different rehabilitation programs in ... The aim of this study was to evaluate the long-term outcomes after rehabilitation programs in long COVID syndrome patients.

8. erar.springeropen.com erar.springeropen.com/articles/10.1186/s43166-023-00227-4

The effect of comprehensive rehabilitation on post-COVID-19 ... The comprehensive rehabilitation program improves quality of life, reduces fatigue, anxiety, and depression, and regains function in patients with post-COVID- ...

9. nature.com nature.com/articles/s41591-023-02521-2

Postacute sequelae of COVID-19 at 2 years SARS-CoV-2 infection can lead to postacute sequelae in multiple organ systems, but evidence is mostly limited to the first year postinfection.