Recruiting

Observational Study

Sponsor:

Indiana University

Code:

NCT07128095

Conditions

COVID-19

Sleep

Immunization; Infection

Physical Inactivity

Blood Pressure

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Study Details

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.

Conditions

COVID-19

Sleep

Immunization; Infection

Physical Inactivity

Blood Pressure

Study ID

NCT07128095

Start date

Aug 22, 2025

Status verified date

Oct, 2025

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

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).

Primary outcome measure

  • Brachial blood pressure [ Time Frame: Through study completion (two-1.5 hour study visits) ]
  • 24-hour ambulatory blood pressure [ Time Frame: During the second data collection visit ]

Central Contacts and Locations

Central contacts

Locations

Indiana University School of Public Health

Recruiting

Bloomington, Indiana, United States, 47405

Contacts

Austin T Robinson, PhD

574-514-1034ausrobin@iu.edu

More Information

Sponsor

Indiana University

Last update posted

Oct 30, 2025

Last verified

Oct, 2025

Keywords

  • COVID-19
  • Sleep
  • Immunization; Infection
  • Physical Inactivity
  • Blood Pressure
  • Diet Habit
  • Mental Wellness

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-16. This information was provided to ClinicalTrials.gov by Indiana University on 2025-10-30.