Continuous vs Aerobic Postexercise Hypotension

NCT03313375 | Terminated DMC

• 1 other identifier: ASU-STUDY00006782
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

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.

Conditions

Postexercise Hypotension

Keywords

hemodynamics; exercise

Outcome Measures

Primary Outcomes (1)

• Postexercise Blood pressure

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

  Postexercise- every ten minutes for four hours post exercise session

Secondary Outcomes (3)

• Heart Rate Variability

  until study completion- up to 2 years

• Cardiac Output- non-invasive

  until study completion- up to 2 years

• Systemic Vascular Resistance

  until study completion- up to 2 years

Study Arms (3)

Control

NO INTERVENTION

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).

Continuous exercise

ACTIVE COMPARATOR

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

Aerobic Interval Exercise

EXPERIMENTAL

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

Interventions

Continuous Exercise OTHER

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.

Also known as: CE

Continuous exercise

Aerobic Interval Exercise OTHER

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.

Also known as: AIE

Aerobic Interval Exercise

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arizona State University: lead

Study Sites (2)

Arizona Biocollaborative Building- Healthy Lifestyle research labratory

Phoenix, Arizona, 85004, United States

Location

Arizona Biomedical Collaborative 1

Phoenix, Arizona, 85004, United States

Location

Related Publications (12)

• 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.

  PMID: 18061058 BACKGROUND

• 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.

  PMID: 12748199 BACKGROUND

• 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.

  PMID: 22753224 BACKGROUND

• 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.

  PMID: 15076798 BACKGROUND

• 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.

  PMID: 20072145 BACKGROUND

• 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.

  PMID: 11689735 BACKGROUND

• 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.

  PMID: 16625235 BACKGROUND

• 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.

  PMID: 25785706 BACKGROUND

• 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.

  PMID: 17406886 BACKGROUND

• 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.

  PMID: 22899388 BACKGROUND

• 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.

  PMID: 27168471 BACKGROUND

• 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.

  PMID: 26293124 BACKGROUND

MeSH Terms

Conditions

Post-Exercise Hypotension; Motor Activity

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Hypotension; Vascular Diseases; Cardiovascular Diseases; Behavior

Study Officials

• Siddhartha Angadi, PhD

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: October 5, 2017
• First Posted: October 18, 2017
• Study Start: October 5, 2017
• Primary Completion: February 7, 2020
• Study Completion: February 7, 2020
• Last Updated: February 10, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)