COVID-19NCT06065033
Exercise Interventions in Post-acute Sequelae of Covid-19
A study testing Exercise in people with COVID-19, run by University of Virginia at 1 site in United States.
Trial summary
The COVID-19 pandemic severely impacted the medical system both directly but also through incomplete recovery from the virus in the form of post-acute sequelae of COVID-19 (PASC). PASC affects at least 9.6 million individuals as of May 2022 and continues to affect many more. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2023to 29 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-50 years of age
- Diagnosed with Post Acute Sequelae of COVID-19
- Physician clearance to undergo exercise training (see section titled cardiorespiratory fitness testing for details; page 6)
- Complete COVID-19 vaccination status
Who cannot join
- Unstable angina or myocardial infarction in the past 4 weeks
- Uncompensated heart failure
- NYHA class IV symptoms
- Complex ventricular arrhythmias
- Musculoskeletal contraindications to stationary bicycling exercise
- Symptomatic severe aortic stenosis
Show all 23Show fewer
- Acute pulmonary embolus
- Acute myocarditis
- Uncontrolled Hypertension as defined as systolic blood pressure > 180 mm Hg or diastolic blood pressure > 120 mm Hg
- Medication non-compliance
- Pregnant women-self reported
- COPD GOLD stage D
- Malignancy currently actively being treated
- Uncontrolled Asthma
- Uncompensated Cirrhosis of the Liver
- Chronic Kidney disease requiring dialysis therapy
- Symptomatic Anemia
- Hemoglobin <7g/dL
- Poorly controlled diabetes or A1c>9%
- BMI >35kg/m2
- Pulmonary Hypertension stage IV
- Any condition requiring supplemental oxygen
- Multiple Sclerosis
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia University Hospital
Charlottesville, Virginia, 22903
About this study
Official title: Exercise as a Therapeutic for Those Diagnosed With Post-acute Sequelae of Covid-19
The COVID-19 pandemic severely impacted the medical system both directly but also through incomplete recovery from the virus in the form of post-acute sequelae of COVID-19 (PASC). PASC affects at least 9.6 million individuals as of May 2022 and continues to affect many more. PASC is a multisystem disorder often presenting with mental fog, dyspnea on exertion, and fatigue among other symptoms. The etiology of PASC is uncertain but theories include direct cytotoxicity, dysregulated immune responses, endotheliitis associated with microthrombi, eNOS uncoupling, and myocardial fibrosis with impaired ventricular compliance. To date, there are no established treatments. Exercise has the potential as a therapeutic option to improve VO2peak and improve each of the aforementioned underlying etiologies. The investigators plan to examine the effect of High-Intensity Interval Training (HIIT) and Moderate intensity exercise training (MOD) on the symptoms and exercise tolerance of patients with PASC.
The investigators approach will consist of a randomized, blinded, 2-arm, parallel-group design. Enrolled subjects will be randomly assigned to one of two groups in a 1:1 allocation ratio. All groups will undergo a 4-week intervention of 3 days of HIIT per week and 2 days of MOD per week or control of light stretching and controlled breathing. Subjects will be assessed before and after the 4-week intervention to examine the extent to which 4 weeks of the HIIT and MOD combination improves VO2peak and left ventricular diastolic function, global longitudinal strain (GLS), and global circumferential strain (GCS). Further, the investigators will explore changes in markers such as heart rate, heart rhythm, blood pressure, quality of life, exercise tolerance, and PASC symptoms as well as blood/serum markers.
- Conditions
- COVID-19
- Being tested
- Exercise
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Patients will perform 5 days of supervised stationary cycling exercise (with EKG telemetry) per week over a period of 4 weeks. Training heart rates will be determined based on the pre-testing VO2peak and peak heart rate (PHR).
- Of the 5 sessions, 3 will be HIIT sessions and 2 will be MOD sessions.
- Subjects exercising on the HIIT day will start with eight intervals of 2-min duration at 80-85% of PHR, separated by 2 min of recovery at 50% of PHR, progressing to four, 4-min intervals at 90-95% PHR, separated by 3 min at 50% PHR by the end of week 2.
- Subjects exercising on the MOD days will perform uninterrupted for 40 minutes duration at 60-65% of PHR progressing to 40 minutes duration at 70-75% of PHR by the end of week 2.
- Each training session will begin with a 10-min warm-up at 50% PHR and end with a 5-min cool down at 50% PHR. Exercise progression may have to be modified according to individual subject exercise tolerance.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Patients will perform 5 days of supervised stationary cycling exercise (with EKG telemetry) per week over a period of 4 weeks. Training heart rates will be determined based on the pre-testing VO2peak and peak heart rate (PHR).
* Of the 5 sessions, 3 will be HIIT sessions and 2 will be MOD sessions.
* Subjects exercising on the HIIT day will start with eight intervals of 2-min duration at 80-85% of PHR, separated by 2 min of recovery at 50% of PHR, progressing to four, 4-min intervals at 90-95% PHR, separated by 3 min at 50% PHR by the end of week 2.
* Subjects exercising on the MOD days will perform uninterrupted for 40 minutes duration at 60-65% of PHR progressing to 40 minutes duration at 70-75% of PHR by the end of week 2.
* Each training session will begin with a 10-min warm-up at 50% PHR and end with a 5-min cool down at 50% PHR. Exercise progression may have to be modified according to individual subject exercise tolerance. Receives: Behavioral: Exercise |
| Control | No intervention | The control protocol will include a combination of light stretching and controlled breathing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2peak
Change in VO2peak (L/min) measured pre- and post-intervention
Measured: 4 weeks
Left ventricular strain
Global longitudinal strain and global circumferential strain measured pre- and post-intervention
Measured: 4 weeks
Left ventricular diastolic function
Diastolic dysfunction grade measured pre- and post-intervention
Measured: 4 weeks
Secondary outcomes (16)
Forced expiratory volume in one second (FEV1)
FEV1 measured via spirometry pre- and post-intervention
Measured: 4 weeks
Forced vital capacity (FVC)
FVC measured via spirometry pre- and post-intervention
Measured: 4 weeks
Post COVID-19 Functional Status scale
Measures subjects functional limitations due to COVID-19 and will be measured via pre- and post-intervention
Measured: 4 weeks
Symptom Burden Questionnaire for Long Covid (SBQ-LC)
Burden of symptoms will be via the SBQ-LC measured pre- and post-intervention
Measured: 4 weeks
International Physical Activity Questionnaire (IPAQ)
Physical activity levels will be assessed via IPAQ measured pre- and post-intervention
Measured: 4 weeks
NTproBNP
Assess changes in NTproBNP (pg/ml) as a biomarker of myocardial strain at pre- and post-intervention
Measured: 4 weeks
C-reactive protein (CRP)
C-reactive protein (mg/dl) will be used as a biomarker for inflammation to be measured pre- and post-intervention
Measured: 4 weeks
Lipids
A lipid panel will be performed to measure total cholesterol, triglycerides, high-density lipoproteins, and low-density lipoprotein (mg/dl) to assess changes in cardiometabolic health pre- and post-intervention
Measured: 4 weeks
Fasting glucose
Fasting blood glucose levels (mg/dl) will be tested to assess changes in cardiometabolic health pre- and post-intervention
Measured: 4 weeks
Insulin
Fasting insulin levels (U/ml) will be tested to assess changes in cardiometabolic health pre- and post-intervention
Measured: 4 weeks
Erythrocyte sedimentation rate (ESR)
ESR will be measured to assess inflammation pre- and post-intervention
Measured: 4 weeks
IL-1
Inflammation will be measured via IL-1 pre- and post-intervention
Measured: 4 weeks
IL-6
Inflammation will be measured via IL-6 pre- and post-intervention
Measured: 4 weeks
TNF-a
Inflammation will be measured via TNF-a pre- and post-intervention
Measured: 4 weeks
Fibrinogen
Fibrinogen will be measured pre- and post-intervention to measure clotting
Measured: 4 weeks
D-dimer
D-dimer will be measured pre- and post-intervention to measure clotting
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start9 Sep 2023
- Primary completion29 Mar 2024
- Study completion29 Mar 2024
Why it stopped: Personnel issues.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Our approach will consist of a randomized, blinded, 2-arm, parallel-group design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Siddartha Angadi, University of Virginia
- Investigators
- Siddhartha S Angadi, PhD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06065033
- Sponsor's protocol ID
- HSR230278
- Status last verified
- May 2024
- First submitted
- 29 Sep 2023
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise as a Therapeutic for Those Diagnosed With Post-acute Sequelae of Covid-19
- ClinicalTrials.gov ID
- NCT06065033
- Acronym / sponsor ID
- HSR230278
- Conditions
- COVID-19
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Personnel issues.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 9 Sep 2023 (actual)
- Primary completion
- 29 Mar 2024 (actual)
- Study completion
- 29 Mar 2024 (actual)
- First posted
- 3 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The COVID-19 pandemic severely impacted the medical system both directly but also through incomplete recovery from the virus in the form of post-acute sequelae of COVID-19 (PASC). PASC affects at least 9.6 million individuals as of May 2022 and continues to affect many more. PASC is a multisystem disorder often presenting with mental fog, dyspnea on exertion, and fatigue among other symptoms. The etiology of PASC is uncertain but theories include direct cytotoxicity, dysregulated immune responses, endotheliitis associated with microthrombi, eNOS uncoupling, and myocardial fibrosis with impaired ventricular compliance. To date, there are no established treatments. Exercise has the potential as a therapeutic option to improve VO2peak and improve each of the aforementioned underlying etiologies. The investigators plan to examine the effect of High-Intensity Interval Training (HIIT) and Moderate intensity exercise training (MOD) on the symptoms and exercise tolerance of patients with PASC.
The investigators approach will consist of a randomized, blinded, 2-arm, parallel-group design. Enrolled subjects will be randomly assigned to one of two groups in a 1:1 allocation ratio. All groups will undergo a 4-week intervention of 3 days of HIIT per week and 2 days of MOD per week or control of light stretching and controlled breathing. Subjects will be assessed before and after the 4-week intervention to examine the extent to which 4 weeks of the HIIT and MOD combination improves VO2peak and left ventricular diastolic function, global longitudinal strain (GLS), and global circumferential strain (GCS). Further, the investigators will explore changes in markers such as heart rate, heart rhythm, blood pressure, quality of life, exercise tolerance, and PASC symptoms as well as blood/serum markers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Our approach will consist of a randomized, blinded, 2-arm, parallel-group design
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: ExercisePatients will perform 5 days of supervised stationary cycling exercise (with EKG telemetry) per week over a period of 4 weeks. Training heart rates will be determined based on the pre-testing VO2peak and peak heart rate (PHR). * Of the 5 sessions, 3 will be HIIT sessions and 2 will be MOD sessions. * Subjects exercising on the HIIT day will start with eight intervals of 2-min duration at 80-85% of PHR, separated by 2 min of recovery at 50% of PHR, progressing to four, 4-min intervals at 90-95% PHR, separated by 3 min at 50% PHR by the end of week 2. * Subjects exercising on the MOD days will perform uninterrupted for 40 minutes duration at 60-65% of PHR progressing to 40 minutes duration at 70-75% of PHR by the end of week 2. * Each training session will begin with a 10-min warm-up at 50% PHR and end with a 5-min cool down at 50% PHR. Exercise progression may have to be modified according to individual subject exercise tolerance. |
| Control | No intervention | –The control protocol will include a combination of light stretching and controlled breathing. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18-50 years of age
- Diagnosed with Post Acute Sequelae of COVID-19
- Physician clearance to undergo exercise training (see section titled cardiorespiratory fitness testing for details; page 6)
- Complete COVID-19 vaccination status
Key exclusion criteria (23 listed)
- Unstable angina or myocardial infarction in the past 4 weeks
- Uncompensated heart failure
- NYHA class IV symptoms
- Complex ventricular arrhythmias
- Musculoskeletal contraindications to stationary bicycling exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExercisePatients will perform 5 days of supervised stationary cycling exercise (with EKG telemetry) per week over a period of 4 weeks. Training heart rates will be determined based on the pre-testing VO2peak and peak heart rate (PHR). * Of the 5 sessions, 3 will be HIIT sessions and 2 will be MOD sessions. * Subjects exercising on the HIIT day will start with eight intervals of 2-min duration at 80-85% of PHR, separated by 2 min of recovery at 50% of PHR, progressing to four, 4-min intervals at 90-95% PHR, separated by 3 min at 50% PHR by the end of week 2. * Subjects exercising on the MOD days will perform uninterrupted for 40 minutes duration at 60-65% of PHR progressing to 40 minutes duration at 70-75% of PHR by the end of week 2. * Each training session will begin with a 10-min warm-up at 50% PHR and end with a 5-min cool down at 50% PHR. Exercise progression may have to be modified according to individual subject exercise tolerance. | Behavioural | Exercise |
Primary outcome
VO2peak
Time frame: 4 weeks
Change in VO2peak (L/min) measured pre- and post-intervention
Left ventricular strain
Time frame: 4 weeks
Global longitudinal strain and global circumferential strain measured pre- and post-intervention
Left ventricular diastolic function
Time frame: 4 weeks
Diastolic dysfunction grade measured pre- and post-intervention
16 secondary outcomes
Forced expiratory volume in one second (FEV1)
Time frame: 4 weeks
Forced vital capacity (FVC)
Time frame: 4 weeks
Post COVID-19 Functional Status scale
Time frame: 4 weeks
Symptom Burden Questionnaire for Long Covid (SBQ-LC)
Time frame: 4 weeks
International Physical Activity Questionnaire (IPAQ)
Time frame: 4 weeks
NTproBNP
Time frame: 4 weeks
C-reactive protein (CRP)
Time frame: 4 weeks
Lipids
Time frame: 4 weeks
Fasting glucose
Time frame: 4 weeks
Insulin
Time frame: 4 weeks
Erythrocyte sedimentation rate (ESR)
Time frame: 4 weeks
IL-1
Time frame: 4 weeks
IL-6
Time frame: 4 weeks
TNF-a
Time frame: 4 weeks
Fibrinogen
Time frame: 4 weeks
D-dimer
Time frame: 4 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siddhartha S Angadi, PhD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with COVID-19, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VO2peak (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.