200 Participants Needed

Physical Fatigue for Post-COVID Syndrome

AG
Overseen ByAnthony Gonzalez
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand why people with long COVID feel so tired. Researchers will study how physical fatigue affects those with long COVID and compare the results to healthy individuals. Participants with long COVID will engage in tasks designed to induce physical fatigue, helping researchers learn more about the condition. This trial suits those diagnosed with long COVID who currently experience fatigue or brain fog. As an unphased study, it offers participants the chance to contribute to groundbreaking research that could lead to better understanding and management of long COVID symptoms.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on immunomodulatory therapy, you must have been on it for at least 6 months before the study starts.

What prior data suggests that this protocol is safe for participants?

Research has shown that physical exercise can help people experiencing fatigue due to long COVID, also known as Post-Acute Sequelae of SARS-CoV-2 Infection (PASC). One study found that exercise programs helped long COVID patients walk longer distances. Another study found that various exercise routines could reduce symptoms like shortness of breath and tiredness.

Regarding safety, these studies indicate that physical activities, such as repeated grip exercises, are generally well-tolerated and have not caused any major negative reactions. This suggests that the physical tasks in this trial should be safe for participants. However, consulting a healthcare provider before joining any trial is advisable to ensure suitability.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to understand and address physical fatigue in post-COVID syndrome, which is a common and challenging condition for many recovering patients. Unlike traditional treatments that might focus on medication or rest, this trial uses a physically demanding task, specifically a grip force exertion task, to directly study and potentially improve physical fatigue. By actively engaging participants in this task, researchers hope to uncover insights into how physical fatigue develops and can be managed, offering new avenues for therapy beyond conventional approaches.

What evidence suggests that this trial's treatments could be effective for Post-COVID Syndrome?

Research has shown that physical exercise can help reduce tiredness in people with Long COVID. One study found that exercise programs made individuals feel less tired during daily activities. Another study demonstrated improvements in symptoms like shortness of breath and tiredness through exercise routines. This trial will assess the effects of a physically demanding task, specifically a grip force exertion task, on inducing physical fatigue in participants with Post-Acute Sequelae of SARS-CoV-2 Infection (PASC) and control participants. Although more research is needed, these early results are promising.12456

Who Is on the Research Team?

VC

Vikram Chib, PhD

Principal Investigator

Johns Hopkins University; Kennedy Krieger Institute

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 who have been diagnosed with long COVID syndrome, specifically experiencing fatigue or brain fog. Participants must meet specific criteria indicating they have PASC and are currently feeling fatigued, as verified by certain questionnaires.

Inclusion Criteria

I have been diagnosed with long COVID with a score over 12.
I am currently experiencing fatigue or brain fog.
I am between 18 and 75 years old.

Exclusion Criteria

Have had exposure to metal or metal implants, due to the hazardous effects of the magnetic field
Severe aphasia
I have unstable chest pain.
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Experimental Protocol

Participants perform a physically demanding task (grip force exertion task) repeatedly to induce physical fatigue

Baseline and during experimental protocol
Multiple visits for task performance and MRI acquisition

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months
Data collections at months 0, 3, 6, 12

What Are the Treatments Tested in This Trial?

Interventions

  • Physical Fatigue

Trial Overview

The study aims to uncover how the brain contributes to ongoing fatigue in people who've had COVID-19. It will explore potential biological targets for future drug development and strategies to help rehabilitate those suffering from post-COVID fatigue.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: PASC Participants - Physical Fatigue TaskExperimental Treatment1 Intervention
Group II: Control Participants - Physical Fatigue TaskExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Lead Sponsor

Trials
93
Recruited
25,200+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials
1,403
Recruited
655,000+

Citations

Physical Training Protocols for Improving Dyspnea and ...

Objective: This study aimed to evaluate physical training protocols for alleviating long COVID symptoms, especially dyspnea and fatigue, ...

Effects of a symptom-titrated exercise program on fatigue ...

While exercise in our study has reduced the subjective fatigability during activities of daily living as evidenced by the reduction in FSS ...

Developing effective strategies to optimize physical activity ...

In this review, the authors present an update to the literature relating to PESE in Long Covid and make the case for evidence-based guidelines.

Relationship between post-COVID-19 symptoms and daily ...

Our results indicated that PCS individuals with ME/CFS symptoms presented greater SOB during activity, chest pain, dizziness, and fatigue, along with lower ...

Fatigue and neuromuscular function in long COVID

This study aimed to determine the mechanisms of fatigue by comparing perceived fatigue, objective fatigability, functionality, muscle ...

Exercise Intolerance and Response to Training in Patients ...

Emerging data indicate that exercise training programs improve key outcomes in Long COVID, including peak V̇o2, 6-minute walk distance ...