NCT07128095 COVID-19 Health Adjustments in Nutrition, General Wellness, and Exercise
| NCT ID | NCT07128095 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Indiana University |
| Condition | COVID-19 |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-08-22 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2025-08-22 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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.
Contact & Investigator
Austin T Robinson, PhD
PRINCIPAL INVESTIGATOR
Indiana University
Frequently Asked Questions
Who can join the NCT07128095 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying COVID-19. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07128095 currently recruiting?
Yes, NCT07128095 is actively recruiting participants. Contact the research team at sofosanc@iu.edu for enrollment information.
Where is the NCT07128095 trial being conducted?
This trial is being conducted at Bloomington, United States.
Who is sponsoring the NCT07128095 clinical trial?
NCT07128095 is sponsored by Indiana University. The principal investigator is Austin T Robinson, PhD at Indiana University. The trial plans to enroll 100 participants.
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