COVID-19 Health Adjustments in Nutrition, General Wellness, and Exercise

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorIndiana University

About this trial

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

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial 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.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 1 trial group
Group A: CHANGE participants

Trial outcomes

Primary outcomes

1

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)

Time frame
Through study completion (two-1.5 hour study visits)
2

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.

Time frame
During the second data collection visit

Secondary outcomes

1

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.

Time frame
14 days
2

Objective sleep efficiency

LEAP ActiWatch will be used to quantify the percentage of time in bed actually spent sleeping to calculate sleep efficiency.

Time frame
14 days
3

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.

Time frame
14 days
4

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.

Time frame
14 days

Other outcomes

1

Perceived stress

We will measure perceived stress (using the Perceived Stress Scale) and stress coping ability using the Connor-Davidson Resilience Scale

Time frame
Measured at baseline
2

Blood pressure reactivity

Blood pressure reactivity (via the cold pressor test)

Time frame
Measured for 3 minutes during the second data collection visit
3

Inflammatory markers

Circulating immune cells and inflammatory markers, such as C-reactive protein (CRP), interleukin-6 (IL-6), and potentially other cytokines, will be quantified using blood samples.

Time frame
Measured during the second data collection visit
4

Hope

Measured using adult hope scale. The scale is a 12-item questionnaire measuring an individual's level of hope, where I higher score indicates greater hope.

Time frame
Measured at baseline

Sponsors and contacts

Click on the lead sponsor to view all of their trials.