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Behavioral Intervention
Home-Based Exercise for Post-COVID Fatigue
N/A
Waitlist Available
Led By Jared M. Gollie, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ambulatory patients (with or without a gait aid) 50 years of age or older with a confirmed diagnosis of COVID-19 by polymerase chain reaction (PCR) test, antibody test, or clinical diagnosis and reporting fatigue greater than 12-weeks post-infection
Comparison group: Ambulatory patients (with or without a gait aid) 50 years of age or older with a confirmed diagnosis of COVID-19 by PCR test, antibody test, or clinical diagnosis without the symptom of fatigue reported greater than 12-weeks post-infection and receiving care at the DC VAMC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and week 8
Awards & highlights
Study Summary
This trial aims to understand why post-Covid fatigue impacts veterans and explore a home-based exercise program to help. It will focus on force, oxygen extraction and emotions related to physical activity.
Who is the study for?
This trial is for Veterans aged 50 or older who had COVID-19 and are experiencing fatigue lasting more than 12 weeks post-infection. They must be able to walk (with or without aid), receive care at the DC VAMC, speak English, and be oriented to person, place, and time. Those with a BMI over 40, psychiatric disorders, uncontrolled diseases that make exercise unsafe, or plans to move away within a year cannot join.Check my eligibility
What is being tested?
The study tests if a home-based 'minimal-dose' resistance exercise program can safely improve muscle strength and reduce fatigue in Veterans with long-term COVID-19 effects. It aims to understand how physical activity affects those with post-COVID fatigue by monitoring changes in muscle function and mood.See study design
What are the potential side effects?
While not explicitly stated, potential side effects may include typical reactions to new exercise routines such as muscle soreness, joint pain or discomfort during activities; however safety measures will be taken to minimize risks.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 50 or older, can walk (with or without help), have had COVID-19, and feel tired for more than 12 weeks after.
Select...
I am over 50, can walk (with or without help), have had COVID-19, and don't feel tired for more than 12 weeks after.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and week 8
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and week 8
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Performance fatigability
Secondary outcome measures
30-second sit-to-stand
Fatigue Severity Scale (FSS)
Feeling Scale
+12 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Minimal-Dose Home-Based Resistance ExerciseExperimental Treatment1 Intervention
8-week home-based resistance exercise performed one day per week.
Group II: Standard of CareActive Control1 Intervention
Subjects will be asked to follow standard of care recommendations as prescribed by the physician.
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,551 Total Patients Enrolled
16 Trials studying COVID-19
413,224 Patients Enrolled for COVID-19
Jared M. Gollie, PhDPrincipal InvestigatorWashington DC VA Medical Center, Washington, DC
1 Previous Clinical Trials
30 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 50 or older, can walk (with or without help), have had COVID-19, and feel tired for more than 12 weeks after.I do not have joint pain that would stop me from safely following the study's requirements.Veterans who do not primarily receive care at the DC VAMC.I do not have any severe health issues that could make joining the study unsafe.I am under 50 and either haven't had COVID-19 or was diagnosed less than 12 weeks ago.I cannot walk by myself.I am over 50, can walk (with or without help), have had COVID-19, and don't feel tired for more than 12 weeks after.You have been diagnosed with a mental health condition.You weigh more than 88 pounds for every 4 feet 11 inches of height.
Research Study Groups:
This trial has the following groups:- Group 1: Minimal-Dose Home-Based Resistance Exercise
- Group 2: Standard of Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research endeavor actively seek out participants?
"This particular medical trial is no longer actively recruiting patients, according to clinicaltrials.gov; its last update was on January 24th 2023. However, there are currently 33 other trials which are still looking for participants."
Answered by AI
Has the Food & Drug Administration accepted Minimal-Dose Home-Based Resistance Exercise as a viable therapeutic option?
"The Power team assessed the safety of Minimal-Dose Home-Based Resistance Exercise to be a 2, due to this being an intermediate trial with some backing for its security but no evidence in favor of efficacy."
Answered by AI
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