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Continuous vs Aerobic Postexercise Hypotension (CAPER)

Primary Purpose

Postexercise Hypotension

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Continuous Exercise
Aerobic Interval Exercise
Sponsored by
Arizona State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postexercise Hypotension focused on measuring hemodynamics, exercise

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy, inactive (defined as less than 60 min of moderate to vigorous physical activity per week)
  • Men (age 18-45) and non-pregnant women (age 18-55)
  • Normal BMI and waist circumference (18.5- 24.5 kg/m2 and waist <94 cm ) OR obese (BMI > 30kg/m2 and waist >94 cm).
  • normotensive or prehypertensive blood pressure (SBP <140 and DBP <90) according to JNC guidelines.

Exclusion Criteria:

  • Subjects over age (men >45, women > 55)
  • Subjects who register more than 60 minutes/week of moderate-to-vigorous physical activity via accelerometer
  • Subjects who classify as hypertensive (SBP >140 or DBP >90)
  • Subjects who answer positively (i.e. yes) on The Physical Activity Readiness Questionnaire (PAR-Q).
  • Subjects with known cardiovascular, pulmonary, renal, or metabolic disease, or are having symptoms of these disease will be excluded, following current American College of Sports Medicine guidelines (ACSM).
  • Current smokers
  • Pregnant women
  • Anyone with contraindications to vigorous exercise will be excluded from the study. -Subjects on medications used for the treatment of symptomatic cardiovascular disease will be excluded.

Sites / Locations

  • Arizona Biocollaborative Building- Healthy Lifestyle research labratory
  • Arizona Biomedical Collaborative 1

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Experimental

Arm Label

Control

Continuous exercise

Aerobic Interval Exercise

Arm Description

Subjects will have no intervention. They will be resting in a chair for the entire length of the visit (4-5 hours) where blood pressure will be taken every 10 min, while other non-invasive cardiac measures are taken (I.E. Cardiac output, systemic vascular resistance, heart rate variability).

Subjects will be asked to perform a 45 min exercise bout. After a warmup, the exercise will be 30 minutes at a continuous level. After the exercise period subject will remain in the lab and blood pressure will be measured every 10 minutes for the remainder of the visit (4 hours) while other non-invasive cardiac measures are taken continuously as discussed above.

Subjects will be asked to complete a 43 minute exercise session. After a warmup period, the subjects will complete a 4x4 protocol in that they will alternate 4, 4 minute higher intensity exercise bouts with 3, 3 minute lower intensity bouts. After the exercise, subjects will remain in the lab and blood pressure will be measured every 10 minutes for 4 hours, while other non-invasive cardiac measures are taken continuously as discussed above.

Outcomes

Primary Outcome Measures

Postexercise Blood pressure
Central and peripheral blood pressure (systolic and diastolic) taken via Oscar 2 device.

Secondary Outcome Measures

Heart Rate Variability
Heart rate variability (taken via polar monitor)
Cardiac Output- non-invasive
Non-invasive: taken via physioflow device
Systemic Vascular Resistance
Non-Invasive: Taken via physioflow device

Full Information

First Posted
October 5, 2017
Last Updated
February 7, 2020
Sponsor
Arizona State University
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1. Study Identification

Unique Protocol Identification Number
NCT03313375
Brief Title
Continuous vs Aerobic Postexercise Hypotension
Acronym
CAPER
Official Title
Postexercise Hemodynamics Compared in Obese and Non-Obese Subjects After Aerobic Interval Training
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Terminated
Why Stopped
Loss of funding and personnel
Study Start Date
October 5, 2017 (Actual)
Primary Completion Date
February 7, 2020 (Actual)
Study Completion Date
February 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Arizona State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study examines the effect of obesity and gender on postexercise hypotension with three different randomized exercise protocols or varying intensity. Subjects will be separated into obese and non-obese groups and then further by gender. From there, they will be put through a control, continuous exercise bout, and aerobic interval bout of exercise in a randomized order over three visits. Post exercise blood pressure, as well as other non-invasive cardiac measures will be taken over a 4 hour period.
Detailed Description
Suboptimal blood pressure, defined as >115/75 mmHg by meta-analysis, exhibits a positive relationship with cardiovascular disease, and is the leading attributable risk factor for death. Research has illustrated that even blood pressure (BP) below the hypertensive levels can contribute to increased vascular mortality. It has been demonstrated that for incremental increases in blood pressure (every 20 mmHg systolic or 10 mmHg diastolic) there is a twofold increase in cardiovascular disease risk. However, mounting evidence suggests that increased fitness and physical activity4 may attenuate the typical age related increase in BP to hypertensive levels. Exercise has been recommended as the first line of treatment in prehypertension and suboptimal BP, and a single bout of exercise (as short at 10 min) has been shown to lower BP for up to 12 hours post. It is this extended bout of postexercise hypotension (PEH) that is thought to contribute to the anti-hypertensive effects of exercise. PEH is well documented in lean and overweight individuals, but there is limited data on PEH in obese populations of both genders. Well characterized for lean and overweight individuals matched for BP, how obese men and women react postexercise is largely unknown and undefined. Only a few published studies exist. A recent meta-analysis examined PEH, but only included subjects with a body mass index of < 31 kg/m2. Only one study to date included exclusively obese subjects (all women), but the authors only demonstrated a PEH 10 min postexercise. To date, we are aware of no published data examining BP matched PEH in centrally obese men and women to that of non-obese men and women. Exercise intensity has been shown to play a role in PEH as well. Data from this lab has demonstrated that short duration, high intensity exercise (aerobic interval exercise -AIE) was able to stimulate a greater duration of PEH when compared to that of a longer duration, moderate intensity exercise (continuous exercise- CE) or even sprint like training. One recently published study examines the effects on AIE training of young, obese women. No significant PEH was found after one hour, however, this time period may not have been long enough to see a significant change in PEH, hence why we are proposing a longer postexercise measurement period. The mechanism for which PEH occurs is unclear. It is thought to be from structural, neurohormonal, and vascular effects of exercise, however, how these variables effect PEH in obese vs non-obese populations has not been studied directly. Using non-invasive methods such as heart rate variability (HRV), cardiac output (CO), and systemic vascular resistance (SRV) will assist us in creating a better idea of the mechanism that which PEH occurs, and any clinical difference central obesity has on these factors. A prior study from this lab found that obese subjects had a heterogeneous response in CO and SVR (increased cardiac output and augmented SVR) when compared to that of non-obese matched subjects, but once more these subjects were only evaluated for 1 hour postexercise.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postexercise Hypotension
Keywords
hemodynamics, exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Subjects will have a randomized order of treatment (exercise bouts). Each subject will complete all three (control, cont. exercise, aerobic interval), but in a randomized order.
Masking
Investigator
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Subjects will have no intervention. They will be resting in a chair for the entire length of the visit (4-5 hours) where blood pressure will be taken every 10 min, while other non-invasive cardiac measures are taken (I.E. Cardiac output, systemic vascular resistance, heart rate variability).
Arm Title
Continuous exercise
Arm Type
Active Comparator
Arm Description
Subjects will be asked to perform a 45 min exercise bout. After a warmup, the exercise will be 30 minutes at a continuous level. After the exercise period subject will remain in the lab and blood pressure will be measured every 10 minutes for the remainder of the visit (4 hours) while other non-invasive cardiac measures are taken continuously as discussed above.
Arm Title
Aerobic Interval Exercise
Arm Type
Experimental
Arm Description
Subjects will be asked to complete a 43 minute exercise session. After a warmup period, the subjects will complete a 4x4 protocol in that they will alternate 4, 4 minute higher intensity exercise bouts with 3, 3 minute lower intensity bouts. After the exercise, subjects will remain in the lab and blood pressure will be measured every 10 minutes for 4 hours, while other non-invasive cardiac measures are taken continuously as discussed above.
Intervention Type
Other
Intervention Name(s)
Continuous Exercise
Other Intervention Name(s)
CE
Intervention Description
Subjects will be asked to perform a 45 min exercise bout. 10 minutes will be a warmup (at a work rate associated with 50% heart rate max), 30 minutes at a wattage that elicits 75-80% heart rate max, and a 5 minute cool down period, returning them to approximately 50% heart rate max.
Intervention Type
Other
Intervention Name(s)
Aerobic Interval Exercise
Other Intervention Name(s)
AIE
Intervention Description
Subjects will be asked to complete a 43 minute exercise session. To warm up, subjects will cycle at a work rate associated with 50% HRmax for 10 minutes. Wattage will then increase and subjects will do four 4-minute intervals at a work rate associated with 90%-95% HRmax, separated by 3 minutes of active recovery at a work rate associated with 50% HRmax. Subjects will be given a 5-minute cool-down period at a work rate associated with 50% HRmax.
Primary Outcome Measure Information:
Title
Postexercise Blood pressure
Description
Central and peripheral blood pressure (systolic and diastolic) taken via Oscar 2 device.
Time Frame
Postexercise- every ten minutes for four hours post exercise session
Secondary Outcome Measure Information:
Title
Heart Rate Variability
Description
Heart rate variability (taken via polar monitor)
Time Frame
until study completion- up to 2 years
Title
Cardiac Output- non-invasive
Description
Non-invasive: taken via physioflow device
Time Frame
until study completion- up to 2 years
Title
Systemic Vascular Resistance
Description
Non-Invasive: Taken via physioflow device
Time Frame
until study completion- up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy, inactive (defined as less than 60 min of moderate to vigorous physical activity per week) Men (age 18-45) and non-pregnant women (age 18-55) Normal BMI and waist circumference (18.5- 24.5 kg/m2 and waist <94 cm ) OR obese (BMI > 30kg/m2 and waist >94 cm). normotensive or prehypertensive blood pressure (SBP <140 and DBP <90) according to JNC guidelines. Exclusion Criteria: Subjects over age (men >45, women > 55) Subjects who register more than 60 minutes/week of moderate-to-vigorous physical activity via accelerometer Subjects who classify as hypertensive (SBP >140 or DBP >90) Subjects who answer positively (i.e. yes) on The Physical Activity Readiness Questionnaire (PAR-Q). Subjects with known cardiovascular, pulmonary, renal, or metabolic disease, or are having symptoms of these disease will be excluded, following current American College of Sports Medicine guidelines (ACSM). Current smokers Pregnant women Anyone with contraindications to vigorous exercise will be excluded from the study. -Subjects on medications used for the treatment of symptomatic cardiovascular disease will be excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Siddhartha Angadi, PhD
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona Biocollaborative Building- Healthy Lifestyle research labratory
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
Arizona Biomedical Collaborative 1
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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18061058
Citation
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Continuous vs Aerobic Postexercise Hypotension

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