COVID-19CHANGENCT07128095
COVID-19 Health Adjustments in Nutrition, General Wellness, and Exercise
An observational study of COVID-19 and Sleep, run by Indiana University at 1 site in United States.
Trial summary
The purpose of this study is to find out whether the COVID pandemic has affected participants' current physical activity, fitness, blood pressure, sleep, and mental stress to better understand its long-term health effects. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Sleep, Immunization; Infection
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2025to 31 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Younger than 18 or older than 75. Have a resting blood pressure > 150/90. Have a BMI > 35 Kg/m2 or < 18 Kg/m2. History of metabolic disease (diabetes or renal disease), pulmonary disorders (e.g., COPD, severe asthma, and cystic fibrosis), and cardiovascular disease (peripheral vascular, cardiac, or cerebrovascular). Medical issues that prevent safe exercise (i.e., cardiovascular issues, or muscle/joint issues including painful arthritis). Medical issues that prevent giving blood (e.g., blood thinners). Currently pregnant.
Who may be able to join
- Male and female participants. Are between the ages of 18-75. Have a resting blood pressure no higher than 150/90 (stage 2 hypertension). Have a BMI below 35 kg/m2 (otherwise healthy). Free from metabolic disease (diabetes or renal disease), pulmonary disorders (e.g., COPD, severe asthma, and cystic fibrosis), and cardiovascular disease (peripheral vascular, cardiac, or cerebrovascular).
- Do not have any precluding medical issues that prevent participants from exercising (i.e., cardiovascular issues, or muscle/joint issues including painful arthritis) or giving blood (e.g., blood thinners).
Who cannot join
- Younger than 18 or older than 30. Have a resting blood pressure > 150/90. Have a BMI > 35 Kg/m2 or < 18 Kg/m2. History of metabolic disease (diabetes or renal disease), pulmonary disorders (e.g., COPD, severe asthma, and cystic fibrosis), and cardiovascular disease (peripheral vascular, cardiac, or cerebrovascular).
- Medical issues that prevent safe exercise (i.e., cardiovascular issues, or muscle/joint issues including painful arthritis).
- Medical issues that prevent giving blood (e.g., blood thinners). Currently pregnant.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Indiana University School of Public Health
Bloomington, Indiana, 47405
Austin T Robinson, PhD, 574-514-1034, ausrobin@iu.edu
About this study
The purpose of this study is to find out whether the COVID pandemic has affected participants' current physical activity, fitness, blood pressure, sleep, and mental stress to better understand its long-term health effects. To complete this study, participants will visit the Neurovascular Physiology Laboratory (NVPL) at the Indiana University School of Public Health Bloomington two times, requiring a total commitment of about 6 hours.
Visit 1 involves completing screening questionnaires, a consent document, and additional questionnaires about participant health behaviors (e.g., sleep and physical activity) and general mental and physical health. After the visit, participants will also start tracking their sleep and physical activity using wearable devices for 14 days, diet for at least 3 days, and blood pressure and urine for 24 hours.
Read more
Visit 2 is a second data collection visit, where participants will return the wearable devices. The investigators will measure participants' body composition, take measures of their cardiovascular health, and participants will complete a fitness test on a stationary cycle (exercise bike). The investigators will collect a 24 hour urine sample and take a blood sample to measure participants' blood glucose, electrolytes, hydration biomarkers, and markers of inflammation, as well as to study immune cells. The investigators will take participants' blood pressure at rest and during a hand-in-cold water test, which helps assess how participants' nervous system responds to stress. A full-body scan will measure participant body composition including bone density, muscle mass, and body fat percentage. Finally, participants will complete a cycling test that gradually increases in intensity to measure cardiovascular fitness.
Risks involve potential pain or bruising from blood draws, discomfort from blood pressure cuffs, stress from vigorous cycling, and psychological stress from questionnaires. There's also a slight risk of severe cardiovascular events occurring during exercise and loss of data confidentiality. Finally, the cold water test may result in a rare but noted situation where the body's nervous system overreacts to the cold stimulus, leading to a drop in blood pressure and heart rate. Participants will be monitored by trained staff during all procedures to ensure safety.
Read the detailed description
The investigator will be assessing whether prior severity of COVID-19 or (Post-acute Sequelae of SARS-CoV-2 Infection) PASC is associated with reduced physical activity and cardiorespiratory fitness, impaired blood pressure regulation, worse sleep, or heightened mental stress. Participants will report to the laboratory for two visits.
Visit 1 will be comprised of participant consent, screening, and completing questionnaires surrounding sleep, stress and mental health, food security, and habitual beverage intake. Visit 1 will take approximately 2 hours in total. Participants will be asked to read the consent form at this time and be encouraged to ask any questions. Participants can then: 1) sign the consent form; 2) take it home for further consideration; or 3) decide not to participate. Participants will be screened for eligibility once written informed consent has been given. At the conclusion of the first visit, participants will be given devices to track ambulatory blood pressure for 24 hours, physical activity and sleep for ~14 days, and diet for ≥3 days (i.e., 2 week days and 1 weekend day). 24 hours before the experimental visits, participants will be given a 24-hour urine collection container to measure urine volume, urine electrolyte concentrations, urine electrolyte excretion, and urine osmolality for eventual assessment of biomarkers of kidney function and kidney injury.
Visit 2 will be an experimental visit where each participant will undergo applied physiology measures, body composition, and exercise testing. During experimental visits, a blood draw will take place to assess changes in plasma electrolyte concentration, osmolality, hemoglobin, and hematocrit, and coded samples will be stored for future inflammation measures (e.g., CRP and IL-6) in addition to isolating peripheral blood mononuclear cells (PBMCs) for studying immune cell phenotype. Participants will then have rested BP assessed. Arterial stiffness will be measured using noninvasive tonometry techniques (Pulse Wave Analysis and Pulse Wave Velocity via SphygmoCor XCEL). We will use a hand-in cold-water test (described below) to assess sympathetic nervous system excitation. The cold pressor test is where participants will submerge their hand into an ice-cold bucket of water for three minutes to elicit a sympathetic nervous system stress response. Concurrently, BP reactivity will be assessed using a cold pressor test while participants engage in submaximal exercise on a stationary bicycle. Blood pressure reactivity will be measured at the finger using a finger-specific blood pressure cuff that will measure BP on a beat-to-beat basis. A total-body dual-energy X-ray absorptiometry (iDXA) scan will be used to assess bone mineral density, lean muscle mass, fat mass, and body fat percentage. Participants will finish the visit by completing a submaximal ramp cycling test on an electronically braked cycle ergometer to assess cardiovascular fitness. The test will begin at a low workload and increase incrementally every 30 minutes until the participant reaches 70% of their estimated maximal heart rate. Heart rate, workload, and perceived exertion will be recorded throughout to estimate cardiorespiratory fitness.
Collectively, these measures will enable the investigators to determine the study objectives pertaining to whether prior COVID-19 severity or PASC impacts cardiovascular health, which have important public health implications.
- Conditions
- COVID-19, Sleep, Immunization; Infection, Physical Inactivity, Blood Pressure, Diet Habit
- Keywords
- COVID-19, Sleep, Immunization; Infection, Physical Inactivity, Blood Pressure, Diet Habit, Mental Wellness
- Medical subject headings
- COVID-19, Infections, Sedentary Behavior, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CHANGE participants | Male and female participants. Are between the ages of 18-75. Have a resting blood pressure no higher than 150/90 (stage 2 hypertension). Have a BMI below 35 kg/m2 (otherwise healthy). Free from metabolic disease (diabetes or renal disease), pulmonary disorders (e.g., COPD, severe asthma, and cystic fibrosis), and cardiovascular disease (peripheral vascular, cardiac, or cerebrovascular). Do not have any precluding medical issues that prevent participants from exercising (i.e., cardiovascular issues, or muscle/joint issues including painful arthritis) or giving blood (e.g., blood thinners). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brachial blood pressure
Seated rachial blood pressure will be measured triplicate after at least 5 minutes of rest using an oscillometric device (Suntech CT 40)
Measured: Through study completion (two-1.5 hour study visits)
24-hour ambulatory blood pressure
Participants will wear an Oscar2 (with SphygmoCor) ambulatory blood pressure monitor on their upper arm for up to 24-hours after their second study visit to measure systolic and diastolic blood pressure. The purpose of the ambulatory blood pressure monitoring is to determine blood pressure regulation over an entire day. This blood pressure monitor will be set to automatically take blood pressure every 20 minutes. The monitor records and saves each blood pressure measurement automatically.
Measured: During the second data collection visit
Secondary outcomes (5)
Objective sleep duration
LEAP ActiWatch will be used to quantify sleep duration in hours. Participants will wear the watch units for 14 days. The investigators will assess sleep duration and cross-check actigraphy wear times with a sleep diary.
Measured: 14 days
Objective sleep efficiency
LEAP ActiWatch will be used to quantify the percentage of time in bed actually spent sleeping to calculate sleep efficiency.
Measured: 14 days
Subjective sleep duration
Sleep quality and disturbances will be evaluated using validated self-reported questionnaires, including the Pittsburgh Sleep Quality Index (PSQI), Munich Sleep Questionnaire (MCQ), Insomnia Severity Index (ISI), and an obstructive sleep apnea scale (i.e., STOP-BANG).
The investigators will use the Pittsburgh Sleep Quality Index (PSQI) to assess sleep duration reflective of the one-month period leading into the study. This outcome is specifically referring to self-reported sleep duration in hours.
Measured: 14 days
Subjective sleep quality
The Pittsburgh Sleep Quality Index (PSQI) will assess perceived sleep quality reflective of the one-month period leading into the study. The Insomnia Severity Index, the Munich Sleep Questionnaire, and the Obstructive Sleep Apnea Scale will additionally measure sleep quality.
Measured: 14 days
Diet quality
Diet will be measured by the Nutrition Data System for Research software. We will obtain macronutrients, micronutrients, and the Healthy Eating Index
Measured: Measured at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start22 Aug 2025
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
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.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Austin Robinson, Indiana University
- Investigators
- Austin T Robinson, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07128095
- Sponsor's protocol ID
- IU IRB #27124
- Acronym
- CHANGE
- Status last verified
- Oct 2025
- First submitted
- 11 Aug 2025
- Last updated
- 30 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Unidentified individual participant data will be made available to other researchers upon reasonable request and data and material transfer agreement
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Health Adjustments in Nutrition, General Wellness, and Exercise
- ClinicalTrials.gov ID
- NCT07128095
- Acronym / sponsor ID
- CHANGE / IU IRB #27124
- Conditions
- COVID-19, Sleep, Immunization; Infection, Physical Inactivity, Blood Pressure, Diet Habit
- Keywords
- COVID-19, Sleep, Immunization; Infection, Physical Inactivity, Blood Pressure, Diet Habit, Mental Wellness
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 22 Aug 2025 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 17 Aug 2025 (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 purpose of this study is to find out whether the COVID pandemic has affected participants' current physical activity, fitness, blood pressure, sleep, and mental stress to better understand its long-term health effects. To complete this study, participants will visit the Neurovascular Physiology Laboratory (NVPL) at the Indiana University School of Public Health Bloomington two times, requiring a total commitment of about 6 hours.
Visit 1 involves completing screening questionnaires, a consent document, and additional questionnaires about participant health behaviors (e.g., sleep and physical activity) and general mental and physical health. After the visit, participants will also start tracking their sleep and physical activity using wearable devices for 14 days, diet for at least 3 days, and blood pressure and urine for 24 hours.
Visit 2 is a second data collection visit, where participants will return the wearable devices. The investigators will measure participants' body composition, take measures of their cardiovascular health, and participants will complete a fitness test on a stationary cycle (exercise bike). The investigators will collect a 24 hour urine sample and take a blood sample to measure participants' blood glucose, electrolytes, hydration biomarkers, and markers of inflammation, as well as to study immune cells. The investigators will take participants' blood pressure at rest and during a hand-in-cold water test, which helps assess how participants' nervous system responds to stress. A full-body scan will measure participant body composition including bone density, muscle mass, and body fat percentage. Finally, participants will complete a cycling test that gradually increases in intensity to measure cardiovascular fitness.
Risks involve potential pain or bruising from blood draws, discomfort from blood pressure cuffs, stress from vigorous cycling, and psychological stress from questionnaires. There's also a slight risk of severe cardiovascular events occurring during exercise and loss of data confidentiality. Finally, the cold water test may result in a rare but noted situation where the body's nervous system overreacts to the cold stimulus, leading to a drop in blood pressure and heart rate. Participants will be monitored by trained staff during all procedures to ensure safety.
Detailed description
The investigator will be assessing whether prior severity of COVID-19 or (Post-acute Sequelae of SARS-CoV-2 Infection) PASC is associated with reduced physical activity and cardiorespiratory fitness, impaired blood pressure regulation, worse sleep, or heightened mental stress. Participants will report to the laboratory for two visits.
Visit 1 will be comprised of participant consent, screening, and completing questionnaires surrounding sleep, stress and mental health, food security, and habitual beverage intake. Visit 1 will take approximately 2 hours in total. Participants will be asked to read the consent form at this time and be encouraged to ask any questions. Participants can then: 1) sign the consent form; 2) take it home for further consideration; or 3) decide not to participate. Participants will be screened for eligibility once written informed consent has been given. At the conclusion of the first visit, participants will be given devices to track ambulatory blood pressure for 24 hours, physical activity and sleep for ~14 days, and diet for ≥3 days (i.e., 2 week days and 1 weekend day). 24 hours before the experimental visits, participants will be given a 24-hour urine collection container to measure urine volume, urine electrolyte concentrations, urine electrolyte excretion, and urine osmolality for eventual assessment of biomarkers of kidney function and kidney injury.
Visit 2 will be an experimental visit where each participant will undergo applied physiology measures, body composition, and exercise testing. During experimental visits, a blood draw will take place to assess changes in plasma electrolyte concentration, osmolality, hemoglobin, and hematocrit, and coded samples will be stored for future inflammation measures (e.g., CRP and IL-6) in addition to isolating peripheral blood mononuclear cells (PBMCs) for studying immune cell phenotype. Participants will then have rested BP assessed. Arterial stiffness will be measured using noninvasive tonometry techniques (Pulse Wave Analysis and Pulse Wave Velocity via SphygmoCor XCEL). We will use a hand-in cold-water test (described below) to assess sympathetic nervous system excitation. The cold pressor test is where participants will submerge their hand into an ice-cold bucket of water for three minutes to elicit a sympathetic nervous system stress response. Concurrently, BP reactivity will be assessed using a cold pressor test while participants engage in submaximal exercise on a stationary bicycle. Blood pressure reactivity will be measured at the finger using a finger-specific blood pressure cuff that will measure BP on a beat-to-beat basis. A total-body dual-energy X-ray absorptiometry (iDXA) scan will be used to assess bone mineral density, lean muscle mass, fat mass, and body fat percentage. Participants will finish the visit by completing a submaximal ramp cycling test on an electronically braked cycle ergometer to assess cardiovascular fitness. The test will begin at a low workload and increase incrementally every 30 minutes until the participant reaches 70% of their estimated maximal heart rate. Heart rate, workload, and perceived exertion will be recorded throughout to estimate cardiorespiratory fitness.
Collectively, these measures will enable the investigators to determine the study objectives pertaining to whether prior COVID-19 severity or PASC impacts cardiovascular health, which have important public health implications.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CHANGE participants | – | –Male and female participants. Are between the ages of 18-75. Have a resting blood pressure no higher than 150/90 (stage 2 hypertension). Have a BMI below 35 kg/m2 (otherwise healthy). Free from metabolic disease (diabetes or renal disease), pulmonary disorders (e.g., COPD, severe asthma, and cystic fibrosis), and cardiovascular disease (peripheral vascular, cardiac, or cerebrovascular). Do not have any precluding medical issues that prevent participants from exercising (i.e., cardiovascular issues, or muscle/joint issues including painful arthritis) or giving blood (e.g., blood thinners). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Younger than 18 or older than 75. Have a resting blood pressure > 150/90. Have a BMI > 35 Kg/m2 or < 18 Kg/m2. History of metabolic disease (diabetes or renal disease), pulmonary disorders (e.g., COPD, severe asthma, and cystic fibrosis), and cardiovascular disease (peripheral vascular, cardiac, or cerebrovascular). Medical issues that prevent safe exercise (i.e., cardiovascular issues, or muscle/joint issues including painful arthritis). Medical issues that prevent giving blood (e.g., blood thinners). Currently pregnant.
Key inclusion criteria (2 listed)
- Male and female participants. Are between the ages of 18-75. Have a resting blood pressure no higher than 150/90 (stage 2 hypertension). Have a BMI below 35 kg/m2 (otherwise healthy). Free from metabolic disease (diabetes or renal disease), pulmonary disorders (e.g., COPD, severe asthma, and cystic fibrosis), and cardiovascular disease (peripheral vascular, cardiac, or cerebrovascular).
- Do not have any precluding medical issues that prevent participants from exercising (i.e., cardiovascular issues, or muscle/joint issues including painful arthritis) or giving blood (e.g., blood thinners).
Key exclusion criteria (3 listed)
- Younger than 18 or older than 30. Have a resting blood pressure > 150/90. Have a BMI > 35 Kg/m2 or < 18 Kg/m2. History of metabolic disease (diabetes or renal disease), pulmonary disorders (e.g., COPD, severe asthma, and cystic fibrosis), and cardiovascular disease (peripheral vascular, cardiac, or cerebrovascular).
- Medical issues that prevent safe exercise (i.e., cardiovascular issues, or muscle/joint issues including painful arthritis).
- Medical issues that prevent giving blood (e.g., blood thinners). Currently pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Brachial blood pressure
Time frame: Through study completion (two-1.5 hour study visits)
Seated rachial blood pressure will be measured triplicate after at least 5 minutes of rest using an oscillometric device (Suntech CT 40)
24-hour ambulatory blood pressure
Time frame: During the second data collection visit
Participants will wear an Oscar2 (with SphygmoCor) ambulatory blood pressure monitor on their upper arm for up to 24-hours after their second study visit to measure systolic and diastolic blood pressure. The purpose of the ambulatory blood pressure monitoring is to determine blood pressure regulation over an entire day. This blood pressure monitor will be set to automatically take blood pressure every 20 minutes. The monitor records and saves each blood pressure measurement automatically.
5 secondary outcomes
Objective sleep duration
Time frame: 14 days
Objective sleep efficiency
Time frame: 14 days
Subjective sleep duration
Time frame: 14 days
Subjective sleep quality
Time frame: 14 days
Diet quality
Time frame: Measured at baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2025.
- Individual participant dataSharing planned: Yes. Unidentified individual participant data will be made available to other researchers upon reasonable request and data and material transfer agreement
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
Austin T Robinson, PhD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Sleep, run by Indiana University 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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 30 Oct 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sofia Sanchez (8126226405, sofosanc@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brachial blood pressure (time frame: Through study completion (two-1.5 hour study visits)). The study lists 2 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 30 Oct 2025.