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Postexercise HypotensionCAPERNCT03313375

Continuous vs Aerobic Postexercise Hypotension

A study testing Continuous Exercise and Aerobic Interval Exercise in people with Postexercise Hypotension, run by Arizona State University at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Postexercise Hypotension
What is being tested?
Continuous Exercise and Aerobic Interval Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
2 sitesUnited States
Study dates
5 Oct 2017to 7 Feb 2020
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 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Arizona Biocollaborative Building- Healthy Lifestyle research labratory

    Phoenix, Arizona, 85004

  • Arizona Biomedical Collaborative 1

    Phoenix, Arizona, 85004

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Continuous Exercise, Aerobic Interval Exercise
Keywords
hemodynamics, exercise
Medical subject headings
Post-Exercise Hypotension, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Continuous ExerciseOther

    Also called CE

    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.

  • Aerobic Interval ExerciseOther

    Also called AIE

    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.

Study groups in NCT03313375
Study groupRoleWhat they receive
ControlNo interventionSubjects 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).
Continuous exerciseActive comparatorSubjects 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.
Receives: Other: Continuous Exercise
Aerobic Interval ExerciseExperimentalSubjects 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.
Receives: Other: Aerobic Interval Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postexercise Blood pressure

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

    Measured: Postexercise- every ten minutes for four hours post exercise session

Secondary outcomes (3)
  1. Heart Rate Variability

    Heart rate variability (taken via polar monitor)

    Measured: until study completion- up to 2 years

  2. Cardiac Output- non-invasive

    Non-invasive: taken via physioflow device

    Measured: until study completion- up to 2 years

  3. Systemic Vascular Resistance

    Non-Invasive: Taken via physioflow device

    Measured: until study completion- up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2017
  2. Study start5 Oct 2017
  3. Primary completion7 Feb 2020
  4. Study completion7 Feb 2020

Why it stopped: Loss of funding and personnel

Resources

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
Treatment
Allocation
Randomised
Intervention model
Crossover
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
Single blind
Who is masked
Investigator
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03313375
Sponsor's protocol ID
ASU-STUDY00006782
Acronym
CAPER
Status last verified
Feb 2020
First submitted
5 Oct 2017
Last updated
10 Feb 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Prospective Studies Collaboration; Lewington S, Whitlock G, Clarke R, Sherliker P, Emberson J, Halsey J, Qizilbash N, Peto R, Collins R. Blood cholesterol and vascular mortality by age, sex, and blood pressure: a meta-analysis of individual data from 61 prospective studies with 55,000 vascular deaths. Lancet. 2007 Dec 1;370(9602):1829-39. doi: 10.1016/S0140-6736(07)61778-4.

    PubMed 18061058
  • Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, Jones DW, Materson BJ, Oparil S, Wright JT Jr, Roccella EJ; National Heart, Lung, and Blood Institute Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure; National High Blood Pressure Education Program Coordinating Committee. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA. 2003 May 21;289(19):2560-72. doi: 10.1001/jama.289.19.2560. Epub 2003 May 14.

    PubMed 12748199
  • Faselis C, Doumas M, Kokkinos JP, Panagiotakos D, Kheirbek R, Sheriff HM, Hare K, Papademetriou V, Fletcher R, Kokkinos P. Exercise capacity and progression from prehypertension to hypertension. Hypertension. 2012 Aug;60(2):333-8. doi: 10.1161/HYPERTENSIONAHA.112.196493. Epub 2012 Jul 2.

    PubMed 22753224
  • Pescatello LS, Franklin BA, Fagard R, Farquhar WB, Kelley GA, Ray CA; American College of Sports Medicine. American College of Sports Medicine position stand. Exercise and hypertension. Med Sci Sports Exerc. 2004 Mar;36(3):533-53. doi: 10.1249/01.mss.0000115224.88514.3a.

    PubMed 15076798
  • Angadi SS, Weltman A, Watson-Winfield D, Weltman J, Frick K, Patrie J, Gaesser GA. Effect of fractionized vs continuous, single-session exercise on blood pressure in adults. J Hum Hypertens. 2010 Apr;24(4):300-2. doi: 10.1038/jhh.2009.110. Epub 2010 Jan 14. No abstract available.

    PubMed 20072145
  • Pescatello LS, Kulikowich JM. The aftereffects of dynamic exercise on ambulatory blood pressure. Med Sci Sports Exerc. 2001 Nov;33(11):1855-61. doi: 10.1097/00005768-200111000-00009.

    PubMed 11689735
  • Hamer M, Boutcher SH. Impact of moderate overweight and body composition on postexercise hemodynamic responses in healthy men. J Hum Hypertens. 2006 Aug;20(8):612-7. doi: 10.1038/sj.jhh.1002035. Epub 2006 Apr 20.

    PubMed 16625235
  • Angadi SS, Bhammar DM, Gaesser GA. Postexercise Hypotension After Continuous, Aerobic Interval, and Sprint Interval Exercise. J Strength Cond Res. 2015 Oct;29(10):2888-93. doi: 10.1519/JSC.0000000000000939.

    PubMed 25785706
  • Figueroa A, Baynard T, Fernhall B, Carhart R, Kanaley JA. Endurance training improves post-exercise cardiac autonomic modulation in obese women with and without type 2 diabetes. Eur J Appl Physiol. 2007 Jul;100(4):437-44. doi: 10.1007/s00421-007-0446-3. Epub 2007 Apr 4.

    PubMed 17406886
  • Liu S, Goodman J, Nolan R, Lacombe S, Thomas SG. Blood pressure responses to acute and chronic exercise are related in prehypertension. Med Sci Sports Exerc. 2012 Sep;44(9):1644-52. doi: 10.1249/MSS.0b013e31825408fb.

    PubMed 22899388
  • Carpio-Rivera E, Moncada-Jimenez J, Salazar-Rojas W, Solera-Herrera A. Acute Effects of Exercise on Blood Pressure: A Meta-Analytic Investigation. Arq Bras Cardiol. 2016 May;106(5):422-33. doi: 10.5935/abc.20160064. Epub 2016 May 6.

    PubMed 27168471
  • Bonsu B, Terblanche E. The training and detraining effect of high-intensity interval training on post-exercise hypotension in young overweight/obese women. Eur J Appl Physiol. 2016 Jan;116(1):77-84. doi: 10.1007/s00421-015-3224-7. Epub 2015 Aug 21.

    PubMed 26293124

Questions about this trial

What is this clinical trial studying?

A study testing Continuous Exercise and Aerobic Interval Exercise in people with Postexercise Hypotension, run by Arizona State University at 2 sites 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 4 inclusion and 8 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: stopped early, as of the sponsor's last update on 10 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 was stopped early (reason given: Loss of funding and personnel). Results are not available in the source record.

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?

Postexercise Blood pressure (time frame: Postexercise- every ten minutes for four hours post exercise session). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03313375, which also lists 12 linked publications.

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 10 Feb 2020.

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