Continuous vs Aerobic Postexercise Hypotension (CAPER)

February 7, 2020 updated by: Siddhartha Angadi, Arizona State University

Postexercise Hemodynamics Compared in Obese and Non-Obese Subjects After Aerobic Interval Training

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85004
        • Arizona Biocollaborative Building- Healthy Lifestyle research labratory
      • Phoenix, Arizona, United States, 85004
        • Arizona Biomedical Collaborative 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control
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).
ACTIVE_COMPARATOR: Continuous exercise
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.
Other: Continuous Exercise
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.
Other Names:
  • CE
EXPERIMENTAL: Aerobic Interval Exercise
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.
Other: Aerobic Interval Exercise
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.
Other Names:
  • AIE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postexercise Blood pressure
Time Frame: Postexercise- every ten minutes for four hours post exercise session
Central and peripheral blood pressure (systolic and diastolic) taken via Oscar 2 device.
Postexercise- every ten minutes for four hours post exercise session

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Rate Variability
Time Frame: until study completion- up to 2 years
Heart rate variability (taken via polar monitor)
until study completion- up to 2 years
Cardiac Output- non-invasive
Time Frame: until study completion- up to 2 years
Non-invasive: taken via physioflow device
until study completion- up to 2 years
Systemic Vascular Resistance
Time Frame: until study completion- up to 2 years
Non-Invasive: Taken via physioflow device
until study completion- up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arizona State University

Investigators

  • Principal Investigator: Siddhartha Angadi, PhD, Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 5, 2017

Primary Completion (ACTUAL)

February 7, 2020

Study Completion (ACTUAL)

February 7, 2020

Study Registration Dates

First Submitted

October 5, 2017

First Submitted That Met QC Criteria

October 13, 2017

First Posted (ACTUAL)

October 18, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 10, 2020

Last Update Submitted That Met QC Criteria

February 7, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASU-STUDY00006782

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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