Cardiovascular DiseasesFIT & FIRED UPNCT04514354
The Influence of Cardiorespiratory Fitness on Firefighter Cardiovascular Health Under Exercise Conditions
A study testing GEST in people with Cardiovascular Diseases and Post-Exercise Hypotension, run by University of Connecticut at 1 site in United States.
Trial summary
Sudden cardiac death (SCD) is the number one cause of on-duty firefighter death. It is most likely to occur in adults who are not physically fit that engage in sudden vigorous exercise. Cardiorespiratory physical fitness (also known as aerobic fitness) is a major heart disease risk factor. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cardiovascular Diseases, Post-Exercise Hypotension
- What is being tested?
- GEST
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Jan 2016
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects had to be full active duty firefighters employed by the local fire department in central Connecticut (CT).
- Subjects confirmed that they were taking the same medication for four weeks prior to Visit 1 and continued taking that medication throughout the duration of the study.
Who cannot join
- Subjects were excluded from the study if they were not able to comply with all study procedures as described in Visit 1, or in the event of injury or illness that would not enable them to participate.
- If subjects had resting blood pressure readings that were > 160 for systolic blood pressure and/or ≥ 100 mmHg for diastolic blood pressure, they were excluded from the study and referred to their primary care physician for follow up.
- Subjects that were excluded from the study were not penalized in any way by the researchers or the administrators of the local fire department.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Cardiorespiratory Fitness on Firefighter Cardiovascular Health Under Conditions of Heavy Physical Exertion
Sudden cardiac death (SCD) is the number one cause of on-duty firefighter death. It is most likely to occur in adults who are not physically fit that engage in sudden vigorous exercise. Cardiorespiratory physical fitness (also known as aerobic fitness) is a major heart disease risk factor. In FIT and FIRED UP, the study investigators looked at the influence of cardiorespiratory fitness on blood pressure, heart rate, and other heart markers taken from the blood before and after a vigorous exercise test to maximal effort among firefighters from a local fire department in Connecticut. In addition, the investigators also looked at how lifestyle habits including physical activity, nutrition, stress, and sleep may influence our findings. It was hypothesized that aerobically fit firefighters would show less stress on their heart than unfit firefighters.
Read the detailed description
The primary purpose of this study was to examine the influence of cardiorespiratory fitness on the acute release of SCD biomarkers and other cardiovascular disease (CVD) risk factors at rest and in response to a bout of maximal physical exertion among 21 firefighters from a local fire department in Connecticut. The study investigators hypothesized that firefighters that are aerobically fit will have lower levels of biomarkers of SCD and a more favorable CVD risk factor profile at rest and in response to a maximal physical effort than firefighters that are not aerobically fit.
FIT and FIRED UP is based on the theoretical foundation of the health belief and social cognitive models of health behavior change which have been shown effective in improving diet and exercise behaviors in firefighters. Specifically, the investigators sought to identify job-specific risk factors for SCD and CVD in firefighters in order to better tailor an intervention that focuses on providing information, reducing barriers to changing unhealthy behaviors, reducing stress, and increasing firefighter efficacy to engage in healthier behaviors.
All eligible members of the fire department were invited to participate in the study. Visit 1 included an orientation health education session at the fire department in which the study investigators delivered a lecture on physical activity and "heart healthy" habits. Interested subjects were able to review the informed consent and questionnaires.
Subjects completed and signed the informed consent at the beginning of Visit 2. This visit consisted of 4 health-related fitness assessments, including sit-up, push-up, flexibility and handgrip tests. Visits 3 and 4 consisted of measures of cardiovascular health at Hartford Hospital and the control visit. The cardiovascular health measures included body mass index (BMI), waist circumference, exhaled carbon monoxide (CO), vascular health (i.e., carotid intimal medial thickness and arterial stiffness), heart rate variability (HRV), resting BP, the maximum graded cardiopulmonary exercise stress test (GEST), and blood draws pre- and post-GEST to obtain SCD and CVD biomarkers. Firefighters were then attached to an ambulatory blood pressure (ABP) monitor and heart rate monitor for 24hr to assess ambulatory BP and HRV, respectively. Of note is that Visits 3 and 4 were conducted in random order so that study investigators could isolate the influence of the GEST on the ambulatory BP response to exercise from the control rest day. Randomization was performed using www.randomization.com. The control visit included measures of resting and ambulatory BP. In addition, subjects completed paper and pencil questionnaires on the topics of physical activity, nutrition, sleep, and mental health at this visit.
- Conditions
- Cardiovascular Diseases, Post-Exercise Hypotension
- Being tested
- GEST
- Keywords
- Firefighters, Post-Exercise Hypotension, Cardiovascular Disease
- Medical subject headings
- Cardiovascular Diseases, Post-Exercise Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GESTBehavioural
On either Visit 3 or 4, subjects performed a maximal cardiopulmonary GEST following the Balke protocol. Immediately prior to the GEST, the study physician or his designee performed a brief physical examination, in which BP was assessed and all relevant medical information (i.e. medical history, medications, family history) were reviewed. The physician who completed the physical examination remained present during the GEST to monitor the subjects' electrocardiogram (ECG) and other physical signs. After the GEST was completed, the study physician reviewed the ECG for signs of ischemia. Breath-by-breath analysis of expired gases (i.e. oxygen and carbon dioxide) (ParvoMedicsTruneOne® 2400 Metabolic Measurement System, ParvoMedics Inc., Sandy, UT) determined maximal oxygen uptake (VO2max). Heart rate was measured continuously with a 12-lead ECG system and BP was measured by auscultation every 3 minutes during the GEST.
| Study group | Role | What they receive |
|---|---|---|
| GEST Visit | Experimental | As described in the detailed study description, the GEST Visit included measures of cardiovascular health at Hartford Hospital. These measures included BMI, waist circumference, exhaled carbon monoxide (CO), vascular health (i.e., carotid intimal medial thickness and arterial stiffness), HRV, resting BP, the GEST, and blood draws pre- and post-GEST to obtain SCD and CVD biomarkers. Receives: Behavioral: GEST |
| CONTROL Visit | No intervention | On either Visit 3 or 4, subjects performed the CONTROL Visit. Resting auscultatory blood pressure was measured according to AHA standards. At the conclusion of CONTROL, subjects were fitted for the ABP monitor. Subjects were instructed to proceed with normal activities, not to exercise, and to keep their arm still and extended at their side when each ABP measurement was being taken. Subjects carried a standard journal, recording activities performed during each measurement, any unusual physical or emotional events, and sleep and wake times. The following morning, subjects detached the monitor and returned it that day to the study investigators. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Ambulatory Blood Pressure (ABP)
Subjects were attached to an Oscar2 automatic noninvasive ABP monitor (Suntech Medical Instruments Inc., Raleigh, North Carolina, USA) on the nondominant arm to be worn until the next morning. The ABP monitor was programmed to record BP at regular intervals three times per waking hour and two times per sleeping hour.
Measured: ABP was measured at the conclusion of Visits 3 and 4 during weeks 3 and 4.
Change in Resting Blood Pressure
Resting BP was measured according to the American Heart Association (AHA) standards using an automated BPTRU monitor (BPTRU Medical Devices, Coquilam, British Columbia, Canada). Subjects were seated for 5 minutes and then BP was measured three times, 1 minute apart in each arm. If the readings obtained were within 5 mmHg, these values were averaged and recorded as resting BP. If these readings did not agree within 5 mmHg, up to three additional readings were taken. If there were three readings obtained that agreed within 5 mmHg, these values were averaged and recorded as resting BP. If after the additional readings were taken and there were not three readings obtained that agree within 5 mmHg, the three closest values were averaged and recorded as resting BP.
Measured: Resting BP was measured during Visits 3 and 4 during weeks 3 and 4.
Change in Fasted Blood Sampling
The fasting blood sampling occurred prior to and immediately after the GEST and was performed to obtain lipid-lipoprotein profiles and baseline biomarkers associated with cardiovascular disease. A trained phlebotomist collected five tubes of venous blood (52 cc or 3.5 tablespoons) from the antecubital vein of each subject. Serum total cholesterol (mg/dL), triglycerides (mg/dL), high-density lipoprotein cholesterol (HDL-C) (mg/dL), and low-density lipoprotein cholesterol (LDL-C) (mg/dL) were determined by colorimetric enzymatic assays. Serum glucose (mg/dL) was determined by enzymatic/spectrophotometric methods.
Measured: The blood sampling occurred at Visit 3 or 4 during the GEST Visit during week 3 or 4.
Change in Fasted Blood Sampling
The fasting blood sampling occurred prior to and immediately after the GEST and was performed to obtain lipid-lipoprotein profiles and baseline biomarkers associated with cardiovascular disease. A trained phlebotomist collected five tubes of venous blood (52 cc or 3.5 tablespoons) from the antecubital vein of each subject. Serum insulin (uIU/mL) was determined by radioimmunoassay.
Measured: The blood sampling occurred at Visit 3 or 4 during the GEST Visit during week 3 or 4.
Change in Fasted Blood Sampling
The fasting blood sampling occurred prior to and immediately after the GEST and was performed to obtain lipid-lipoprotein profiles and baseline biomarkers associated with cardiovascular disease. A trained phlebotomist collected five tubes of venous blood (52 cc or 3.5 tablespoons) from the antecubital vein of each subject. High sensitivity-C-reactive protein (mg/L) was determined by immunoturbidimetry.
Measured: The blood sampling occurred at Visit 3 or 4 during the GEST Visit during week 3 or 4.
Dietary Intake
Usual dietary and alcohol intake were measured using the National Health and Nutrition Examination Survey (NHANES) semi-quantitative Food-Frequency Questionnaire. The NHANES Food Frequency Questionnaire is a validated tool for measuring dietary intake of both macro- and micro-nutrients based on 127 food items. Subjects were asked to self-report their average daily consumption of 124 food items. The data derived from the Food Frequency Questionnaire were coded and analyzed by members of the National Cancer Institute utilizing Diet*Calc software v1.4.3 (Bethesda, MD) in order to produce daily food frequency estimates of the 127 nutrient and dietary constituents. The Diet*Calc software analyzed Diet History Questionnaire data and generated nutrient and food group intake estimates from the Diet History Questionnaire.
Measured: The questionnaire was filled out during Visit 3 or 4 at the Control Visit during week 3 or 4.
Peak Oxygen Consumption
VO2peak was measured by the maximal graded exercise stress test (GEST). The VO2peak test is the gold standard measure of cardiorespiratory fitness.
Measured: The GEST took place either during Visit 3 or 4 during week 3 or 4.
Secondary outcomes (10)
Health-Related Fitness Assessments
Subjects performed four health-related fitness assessments. The first assessment was the Flexibility test. All tests were performed with a one-minute rest between tests.
Measured: The health-related fitness assessments were performed during study Visit 2 during week 2.
Health-Related Fitness Assessments
Subjects performed four health-related fitness assessments. The second assessment was the Handgrip Strength test. All tests were performed with a one-minute rest between tests.
Measured: The health-related fitness assessments were performed during study Visit 2 during week 2.
Health-Related Fitness Assessments
Subjects performed four health-related fitness assessments. The third assessment was the Sit-Up test. All tests were performed with a one-minute rest between tests.
Measured: The health-related fitness assessments were performed during study Visit 2 during week 2.
Health-Related Fitness Assessments
Subjects performed four health-related fitness assessments. The fourth assessment was the Push-Up test. All tests were performed with a one-minute rest between tests.
Measured: The health-related fitness assessments were performed during study Visit 2 during week 2.
Anthropometrics
Height and weight were measured with a calibrated balance beam scale to calculate body mass index (BMI) (kg·m2).
Measured: Anthropometrics were measured during Visit 3 or 4 during the GEST Visit during week 3 or 4.
Anthropometrics
Waist circumference (cm) was measured at the iliac crest using a non-distensible Guilick tape measure.
Measured: Anthropometrics were measured during Visit 3 or 4 during the GEST Visit during week 3 or 4.
Carotid-Intima Media Thickness (cIMT)
Subjects rested in the supine position for 5 minutes. CIMT was measured using doppler ultrasound on the carotid arteries at three sites (common, bulb, and internal bilateral). The artery will be imaged using a 5- to 12-MHz multifrequency linear-array transducer attached to a high-resolution ultrasound machine (Terason t3000; Burlington, MA). The image will be digitized and edge detection software (Carotid Analyzer; Medical Imaging Applications, Inc.) will then be used to trace the lumen-intima and intima-medial boundaries of the artery over a 1 minute clip to calculate the average intima-medial thickness at three sites. Mean and maximal distances will be compared to established norms by age, sex/gender, and race/ethnicity.
Measured: CIMT was measured during Visit 3 or 4 during the GEST Visit during week 3 or 4.
Change in Arterial Stiffness Assessment
The CPV system (SphygmoCor® CPV Central Blood Pressure/Pulse Wave Velocity System) measured pulse wave velocity (PWV). PWV gives an indication of central arterial parameters. Briefly, the subjects rested in the supine position for 10 minutes. After this rest period, central PWV measures (carotid-femoral), and PWA (radial) were made.
Measured: Arterial stiffness was measured during Visit 3 or 4 during the GEST Visit during week 3 or 4.
Change in Resting Heart Rate Variability (HRV)
The resting HRV assessment was performed in a quiet, low-light and temperature-controlled room in the supine position after a 5 min rest period using the GE Case Exercise Testing System (GE Healthcare, Wauwaposa, WI). Following the resting period, electrocardiogram (ECG) RR intervals will be measured in the supine position for 5 min. During these measurements, the subject's breathing frequency was paced at 12 breaths•min-1 with the aid of a metronome.
Measured: Resting HRV was measured during Visit 3 or 4 during the GEST Visit during week 3 or 4.
Change in Ambulatory HRV
Subjects were fitted for a Polar® V800™ HR monitor for the ambulatory HRV assessment for 24 hr. An elastic HR belt was placed below the chest muscles with conductive gel and applied as described by the manufacturer. RR intervals were recorded with a resolution of 1ms and captured by the receptor belt and stored by a wrist watch receiver under free living conditions without controlling for respiratory rate or tidal volume.
Measured: Ambulatory HRV was measured during Visit 3 or 4 during the GEST Visit during week 3 or 4.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2020
- Study startApr 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Collaborators
- Hartford Hospital
- Responsible party
- Principal investigator, Linda Pescatello, University of Connecticut
- Investigators
- Linda S Pescatello, PhD, Principal investigator, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04514354
- Sponsor's protocol ID
- H14-183HH
- Acronym
- FIT & FIRED UP
- Status last verified
- Aug 2020
- First submitted
- 6 Aug 2020
- Last updated
- 14 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Cardiorespiratory Fitness on Firefighter Cardiovascular Health Under Conditions of Heavy Physical Exertion
- ClinicalTrials.gov ID
- NCT04514354
- Acronym / sponsor ID
- FIT & FIRED UP / H14-183HH
- Conditions
- Cardiovascular Diseases, Post-Exercise Hypotension
- Keywords
- Firefighters, Post-Exercise Hypotension, Cardiovascular Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Collaborators
- Hartford Hospital
- Study start
- Apr 2015 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 14 Aug 2020 (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.
Sudden cardiac death (SCD) is the number one cause of on-duty firefighter death. It is most likely to occur in adults who are not physically fit that engage in sudden vigorous exercise. Cardiorespiratory physical fitness (also known as aerobic fitness) is a major heart disease risk factor. In FIT and FIRED UP, the study investigators looked at the influence of cardiorespiratory fitness on blood pressure, heart rate, and other heart markers taken from the blood before and after a vigorous exercise test to maximal effort among firefighters from a local fire department in Connecticut. In addition, the investigators also looked at how lifestyle habits including physical activity, nutrition, stress, and sleep may influence our findings. It was hypothesized that aerobically fit firefighters would show less stress on their heart than unfit firefighters.
Detailed description
The primary purpose of this study was to examine the influence of cardiorespiratory fitness on the acute release of SCD biomarkers and other cardiovascular disease (CVD) risk factors at rest and in response to a bout of maximal physical exertion among 21 firefighters from a local fire department in Connecticut. The study investigators hypothesized that firefighters that are aerobically fit will have lower levels of biomarkers of SCD and a more favorable CVD risk factor profile at rest and in response to a maximal physical effort than firefighters that are not aerobically fit.
FIT and FIRED UP is based on the theoretical foundation of the health belief and social cognitive models of health behavior change which have been shown effective in improving diet and exercise behaviors in firefighters. Specifically, the investigators sought to identify job-specific risk factors for SCD and CVD in firefighters in order to better tailor an intervention that focuses on providing information, reducing barriers to changing unhealthy behaviors, reducing stress, and increasing firefighter efficacy to engage in healthier behaviors.
All eligible members of the fire department were invited to participate in the study. Visit 1 included an orientation health education session at the fire department in which the study investigators delivered a lecture on physical activity and "heart healthy" habits. Interested subjects were able to review the informed consent and questionnaires.
Subjects completed and signed the informed consent at the beginning of Visit 2. This visit consisted of 4 health-related fitness assessments, including sit-up, push-up, flexibility and handgrip tests. Visits 3 and 4 consisted of measures of cardiovascular health at Hartford Hospital and the control visit. The cardiovascular health measures included body mass index (BMI), waist circumference, exhaled carbon monoxide (CO), vascular health (i.e., carotid intimal medial thickness and arterial stiffness), heart rate variability (HRV), resting BP, the maximum graded cardiopulmonary exercise stress test (GEST), and blood draws pre- and post-GEST to obtain SCD and CVD biomarkers. Firefighters were then attached to an ambulatory blood pressure (ABP) monitor and heart rate monitor for 24hr to assess ambulatory BP and HRV, respectively. Of note is that Visits 3 and 4 were conducted in random order so that study investigators could isolate the influence of the GEST on the ambulatory BP response to exercise from the control rest day. Randomization was performed using www.randomization.com. The control visit included measures of resting and ambulatory BP. In addition, subjects completed paper and pencil questionnaires on the topics of physical activity, nutrition, sleep, and mental health at this visit.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GEST Visit | Experimental | Behavioral: GESTAs described in the detailed study description, the GEST Visit included measures of cardiovascular health at Hartford Hospital. These measures included BMI, waist circumference, exhaled carbon monoxide (CO), vascular health (i.e., carotid intimal medial thickness and arterial stiffness), HRV, resting BP, the GEST, and blood draws pre- and post-GEST to obtain SCD and CVD biomarkers. |
| CONTROL Visit | No intervention | –On either Visit 3 or 4, subjects performed the CONTROL Visit. Resting auscultatory blood pressure was measured according to AHA standards. At the conclusion of CONTROL, subjects were fitted for the ABP monitor. Subjects were instructed to proceed with normal activities, not to exercise, and to keep their arm still and extended at their side when each ABP measurement was being taken. Subjects carried a standard journal, recording activities performed during each measurement, any unusual physical or emotional events, and sleep and wake times. The following morning, subjects detached the monitor and returned it that day to the study investigators. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects had to be full active duty firefighters employed by the local fire department in central Connecticut (CT).
- Subjects confirmed that they were taking the same medication for four weeks prior to Visit 1 and continued taking that medication throughout the duration of the study.
Key exclusion criteria (3 listed)
- Subjects were excluded from the study if they were not able to comply with all study procedures as described in Visit 1, or in the event of injury or illness that would not enable them to participate.
- If subjects had resting blood pressure readings that were > 160 for systolic blood pressure and/or ≥ 100 mmHg for diastolic blood pressure, they were excluded from the study and referred to their primary care physician for follow up.
- Subjects that were excluded from the study were not penalized in any way by the researchers or the administrators of the local fire department.
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 |
|---|---|---|
| GESTOn either Visit 3 or 4, subjects performed a maximal cardiopulmonary GEST following the Balke protocol. Immediately prior to the GEST, the study physician or his designee performed a brief physical examination, in which BP was assessed and all relevant medical information (i.e. medical history, medications, family history) were reviewed. The physician who completed the physical examination remained present during the GEST to monitor the subjects' electrocardiogram (ECG) and other physical signs. After the GEST was completed, the study physician reviewed the ECG for signs of ischemia. Breath-by-breath analysis of expired gases (i.e. oxygen and carbon dioxide) (ParvoMedicsTruneOne® 2400 Metabolic Measurement System, ParvoMedics Inc., Sandy, UT) determined maximal oxygen uptake (VO2max). Heart rate was measured continuously with a 12-lead ECG system and BP was measured by auscultation every 3 minutes during the GEST. | Behavioural | GEST Visit |
Primary outcome
Change in Ambulatory Blood Pressure (ABP)
Time frame: ABP was measured at the conclusion of Visits 3 and 4 during weeks 3 and 4.
Subjects were attached to an Oscar2 automatic noninvasive ABP monitor (Suntech Medical Instruments Inc., Raleigh, North Carolina, USA) on the nondominant arm to be worn until the next morning. The ABP monitor was programmed to record BP at regular intervals three times per waking hour and two times per sleeping hour.
Change in Resting Blood Pressure
Time frame: Resting BP was measured during Visits 3 and 4 during weeks 3 and 4.
Resting BP was measured according to the American Heart Association (AHA) standards using an automated BPTRU monitor (BPTRU Medical Devices, Coquilam, British Columbia, Canada). Subjects were seated for 5 minutes and then BP was measured three times, 1 minute apart in each arm. If the readings obtained were within 5 mmHg, these values were averaged and recorded as resting BP. If these readings did not agree within 5 mmHg, up to three additional readings were taken. If there were three readings obtained that agreed within 5 mmHg, these values were averaged and recorded as resting BP. If after the additional readings were taken and there were not three readings obtained that agree within 5 mmHg, the three closest values were averaged and recorded as resting BP.
Change in Fasted Blood Sampling
Time frame: The blood sampling occurred at Visit 3 or 4 during the GEST Visit during week 3 or 4.
The fasting blood sampling occurred prior to and immediately after the GEST and was performed to obtain lipid-lipoprotein profiles and baseline biomarkers associated with cardiovascular disease. A trained phlebotomist collected five tubes of venous blood (52 cc or 3.5 tablespoons) from the antecubital vein of each subject. Serum total cholesterol (mg/dL), triglycerides (mg/dL), high-density lipoprotein cholesterol (HDL-C) (mg/dL), and low-density lipoprotein cholesterol (LDL-C) (mg/dL) were determined by colorimetric enzymatic assays. Serum glucose (mg/dL) was determined by enzymatic/spectrophotometric methods.
Change in Fasted Blood Sampling
Time frame: The blood sampling occurred at Visit 3 or 4 during the GEST Visit during week 3 or 4.
The fasting blood sampling occurred prior to and immediately after the GEST and was performed to obtain lipid-lipoprotein profiles and baseline biomarkers associated with cardiovascular disease. A trained phlebotomist collected five tubes of venous blood (52 cc or 3.5 tablespoons) from the antecubital vein of each subject. Serum insulin (uIU/mL) was determined by radioimmunoassay.
Change in Fasted Blood Sampling
Time frame: The blood sampling occurred at Visit 3 or 4 during the GEST Visit during week 3 or 4.
The fasting blood sampling occurred prior to and immediately after the GEST and was performed to obtain lipid-lipoprotein profiles and baseline biomarkers associated with cardiovascular disease. A trained phlebotomist collected five tubes of venous blood (52 cc or 3.5 tablespoons) from the antecubital vein of each subject. High sensitivity-C-reactive protein (mg/L) was determined by immunoturbidimetry.
Dietary Intake
Time frame: The questionnaire was filled out during Visit 3 or 4 at the Control Visit during week 3 or 4.
Usual dietary and alcohol intake were measured using the National Health and Nutrition Examination Survey (NHANES) semi-quantitative Food-Frequency Questionnaire. The NHANES Food Frequency Questionnaire is a validated tool for measuring dietary intake of both macro- and micro-nutrients based on 127 food items. Subjects were asked to self-report their average daily consumption of 124 food items. The data derived from the Food Frequency Questionnaire were coded and analyzed by members of the National Cancer Institute utilizing Diet*Calc software v1.4.3 (Bethesda, MD) in order to produce daily food frequency estimates of the 127 nutrient and dietary constituents. The Diet*Calc software analyzed Diet History Questionnaire data and generated nutrient and food group intake estimates from the Diet History Questionnaire.
Peak Oxygen Consumption
Time frame: The GEST took place either during Visit 3 or 4 during week 3 or 4.
VO2peak was measured by the maximal graded exercise stress test (GEST). The VO2peak test is the gold standard measure of cardiorespiratory fitness.
10 secondary outcomes
Health-Related Fitness Assessments
Time frame: The health-related fitness assessments were performed during study Visit 2 during week 2.
Health-Related Fitness Assessments
Time frame: The health-related fitness assessments were performed during study Visit 2 during week 2.
Health-Related Fitness Assessments
Time frame: The health-related fitness assessments were performed during study Visit 2 during week 2.
Health-Related Fitness Assessments
Time frame: The health-related fitness assessments were performed during study Visit 2 during week 2.
Anthropometrics
Time frame: Anthropometrics were measured during Visit 3 or 4 during the GEST Visit during week 3 or 4.
Anthropometrics
Time frame: Anthropometrics were measured during Visit 3 or 4 during the GEST Visit during week 3 or 4.
Carotid-Intima Media Thickness (cIMT)
Time frame: CIMT was measured during Visit 3 or 4 during the GEST Visit during week 3 or 4.
Change in Arterial Stiffness Assessment
Time frame: Arterial stiffness was measured during Visit 3 or 4 during the GEST Visit during week 3 or 4.
Change in Resting Heart Rate Variability (HRV)
Time frame: Resting HRV was measured during Visit 3 or 4 during the GEST Visit during week 3 or 4.
Change in Ambulatory HRV
Time frame: Ambulatory HRV was measured during Visit 3 or 4 during the GEST Visit during week 3 or 4.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2020.
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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.
Linda S Pescatello, PhD principal investigator
University of Connecticut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GEST in people with Cardiovascular Diseases and Post-Exercise Hypotension, run by University of Connecticut 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: finished, as of the sponsor's last update on 14 Aug 2020. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Ambulatory Blood Pressure (ABP) (time frame: ABP was measured at the conclusion of Visits 3 and 4 during weeks 3 and 4.). The study lists 7 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 14 Aug 2020.