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HypertensionBPVRNCT03016351

Improving Blood Pressure and Cardiovascular Risk With Resistance Exercise in African Americans

A study testing Aerobic Training and Resistance Training in people with Hypertension and Cardiovascular Diseases, run by University of Illinois Chicago at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

After the participant meets all inclusion and exclusion criteria, they will be randomized equally to either the Resistance Training group (RT) or Aerobic Training group (AT). Both groups will participate in an 8 week initial control period, followed by 8 weeks of supervised exercise training, followed by 8 weeks of… Read more about this study

Who is it for?
Ages 18 to 55 years
What is being tested?
Aerobic Training and Resistance Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
1 siteUnited States
Study dates
Oct 2016to Apr 2023
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
  • No healthy volunteers
  • Adult

Who may be able to join

  • Sedentary
  • Body Mass Index of 18.5-40 kg/m²
  • Born in the United States of either two African-American or two non-Hispanic Caucasian parents
  • Blood pressure of at least 120/80 mmHg

Who cannot join

  • Inability to give informed consent
  • History of cardiovascular disease or cardiovascular events
  • Hypertension (systolic >159 mmHg and diastolic >99 mmHg) or on more than one anti-hypertensive medication
  • Diabetes Type I\& II
  • Hyperlipidemia, with an LDL-C >159 mg/dL and /or total-C >229 mg/dL
  • Pregnancy (or intend to become pregnant while participating in study) or nursing
Show all 20Show fewer
  • Tobacco use in the past 6 months (including, but not limited to cigarettes, e-cigarettes, hookah, Nicorette, SNUs and chewing tobacco)
  • Chronic inflammatory disease such as, but not limited to, cancer
  • Chronic autoimmune diseases such as, but not limited to: lupus, multiple sclerosis, rheumatoid arthritis
  • Adverse reaction to nitroglycerin
  • Anemia with a hemoglobin < 8
  • Head injury within last 6 months
  • Seizure disorder
  • Presence of renal disease with a creatinine > 1.5mg/dL
  • Presence of liver disease with liver enzymes > 3x the upper limits of normal
  • Currently abusing alcohol or illicit drugs
  • Unreliability as a study subject, in the opinion of the Investigator
  • Lidocaine allergy
  • Amenorrhea
  • Postmenopausal women

Trial locations and contacts

1 site in 1 country.

Laurel Thur, MS contact

312-355-0277

lathur@uic.edu

Shane Phillips, PhD contact

312-355-0277

shanep@uic.edu

United States1 site, 1 recruiting

  • University of Illinois at Chicago

    Chicago, Illinois, 60612

    Laurel Thur, MS, 312-355-0277, lathur@uic.edu

    Shane Phillips, PhD, 312-355-0277, shanep@uic.edu

    Recruiting

Other trials in United States

About this study

After the participant meets all inclusion and exclusion criteria, they will be randomized equally to either the Resistance Training group (RT) or Aerobic Training group (AT). Both groups will participate in an 8 week initial control period, followed by 8 weeks of supervised exercise training, followed by 8 weeks of deconditioning. All participants will undergo the same assessments and procedures one time prior to the initial 8 week control period, and at each of the three periods. Assessments include: blood draws; arterial stiffness testing; ultrasounds of the brachial artery to measure flow-mediated dilation (FMD); gluteal adipose tissue biopsies; exercise testing to determine VO2 max; body composition analysis via DEXA scans; ambulatory blood pressure measurement; diet analysis via food journals; medical history questionnaires; urine analysis for pregnancy; and activity monitoring via accelerometer. Total participation will be 24-26 weeks.

Read the detailed description

This study is divided into three separate 8-week periods, the Control period, the Exercise Training period and the De-training period. Testing sessions will be done at Week 0, Week 8, Week 16, and Week 24 of the study.

Control Period (weeks 0-8): Participants will have a control period of 8 weeks. Participants will be given a brochure regarding the benefits of regular exercise and nutrition on overall health.

  1. Baseline visit and eligibility assessment, Week 0: After an initial phone interview to screen participants for eligibility, participants will be scheduled for their two sessions of baseline assessments. Randomization After the subject meets all inclusion and exclusion criteria, the participant will be randomized equally to either the Resistance Training group (RT) or Aerobic Training group (AT) with a table of random numbers by a staff member having no knowledge of the participant's baseline profile. V1A (2 hours): Clinical Research Center and/or Integrative Physiology Lab Participants will report to the UIC CRC or UIC Integrative Physiology Lab after a 12 hour fast. Everyone will be instructed to take all prescribed medications as normal and to continue to drink plenty of water. Participants will also be told not to exercise for 24 hours prior to the testing session. Female participants will be in the follicular stage of their menstrual cycle. After informed consent and a medical history obtained, the following procedures will be performed:
  • Urine pregnancy test for women
  • Questionnaires (Health History Questionnaire, Pittsburgh Sleep Quality Index (PSQI), Physical Activity Questionnaire, Automated Self-Administered 24-hour Dietary Assessment Tool (ASA 24), and Alcohol Intake Questionnaire (AIQ)
  • Anthropometrics: weight, height, waist circumference and BMI
  • Vitals: Blood pressure and heart rate
  • Blood draw of approximately 2 tablespoons or 30 mLs
  • Arterial stiffness test via pulse wave velocity: Sphygmocor (SphygmoCor, AtCor Medical, Sydney, Australia) is a device that used to detect the stiffness of blood vessels.
  • Ultrasound for brachial flow-mediated dilation with administration of nitroglycerin
  • Beginning of 24 hour blood pressure monitoring. V1B (2 hours): Integrative Physiology Lab Participants will report to the IPL for the following procedures:
  • Exercise testing: Maximal oxygen consumption will be evaluated using the treadmill to exhaustion.
  • Dual Energy X-ray Absorptiometry (DEXA)
  • Begin 7 days of activity monitoring with accelerometer. V1C (5 minutes): Integrative Physiology Lab Participants will report to the IPL for the following procedures:
  • Return the accelerometer after 7 days of activity monitoring. Exercise Training Period (weeks 9-16): Participants will participate 3 days a week in either the Resistance Training group (RT) or the Aerobic Training group (AT).
  1. Pre-training Testing, Week 8: After the 8 week control period, before training begins, participants will report for two testing visits, and will undergo the following procedures: V2A (2 hours): Clinical Research Center and/or Integrative Physiology Lab: Same as V1A procedures as outlined in the Baseline visit (including the 12 hour fast), with the addition of a subcutaneous gluteal fat biopsy that will be performed in conjunction with the above measures, or scheduled separately at the Clinical Research Center. V2B (2 hours): Integrative Physiology Lab: Participants will report to the IPL for the same procedures as outlined in the Baseline visit (V1B). V2C (5 minutes): Integrative Physiology Lab: Participants will report to the IPL for the same procedures as outlined in the Baseline visit (V1C). Exercise Intervention Groups: Aerobic Training Intervention (weeks 9-16): Subjects will undergo a supervised endurance training program in accordance with established guidelines. Resistance Training Intervention (weeks 9-16): Subjects randomized to 8-week resistance exercise training program will visit the UIC Integrative Physiology exercise research laboratory 3 times per week, 45 min per session.
  2. Post training Testing, Week 16: The two visit post-training testing will start 24-48 hours after last exercise session to avoid potential effects of the acute exercise bout. This testing is identical to the testing that occurred at the beginning of the exercise training period (V2) at Week 8. Participants will report for two testing visits, and will undergo the following procedures: V3A (2 hours): Clinical Research Center and/or Integrative Physiology Lab: Same V2A procedures as outlined in the Pre-Training visit (V2A) (including the 12 hour fast). V3B (2 hours): Integrative Physiology Lab: Participants will report to the IPL for the same procedures as outlined in the Pre-Training visit (V2B). V3C (5 minutes): Integrative Physiology Lab Participants will report to the IPL for the same procedures as outlined in the Pre-Training visit (V2C). De-Training Follow-up (weeks 16- 24): All subjects will be asked to resume normal activities after the 8-week exercise training program.
  3. Post-Detraining Testing, Week 24: All of the procedures described in Post-Training visits will be repeated. Participants will report for two testing visits, and will undergo the following procedures:

V4A (2 hours): Clinical Research Center and/or Integrative Physiology Lab: Same V2A procedures as outlined in the Pre-Training visit (V2A) (including the 12 hour fast).

V4B (2 hours): Integrative Physiology Lab: Participants will report to the IPL for the same procedures as outlined in the Pre-Training visit (V2B).

V4C (5 minutes): Integrative Physiology Lab Participants will report to the IPL for the same procedures as outlined in the Pre-Training visit (V2C).

Being tested
Aerobic Training, Resistance Training
Keywords
Hypertension, Exercise, African Americans, Arterial Function, Arterial Stiffness
Medical subject headings
Hypertension, Cardiovascular Diseases, Vascular Diseases, Motor Activity

What participants receive

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

  • Aerobic TrainingOther

    After the subject meets all inclusion and exclusion criteria, the subject will be randomized equally to either the ResistanceTraining group (RT) or Aerobic Training group (AT) for weeks 9-16 of the intervention. The participants will be supervised by physical therapists and/or exercise physiologists. Sessions will occur 3 days a week and will be 45 minutes in duration.

  • Resistance TrainingOther

    After the subject meets all inclusion and exclusion criteria, the subject will be randomized equally to either the ResistanceTraining group (RT) or Aerobic Training group (AT) for weeks 9-16 of the intervention. The participants will be supervised by physical therapists and/or exercise physiologists. Sessions will occur 3 days a week and will be 45 minutes in duration.

Study groups in NCT03016351
Study groupRoleWhat they receive
Aerobic TrainingExperimentalParticipants will undergo a supervised endurance training program in accordance with established guidelines. Each session will be monitored by a physical therapist or exercise physiologist. Sessions will be carried out 3 times per week. During each session, participants will complete a 5 min warm-up followed by 30-45 min of endurance exercise using cycle ergometry. Intensity will be monitored using heart rate monitors during each exercise session, and each participant will receive an exercise prescription with a heart range equivalent to 65-85% of their heart rate max. Participants will be asked to complete 30 min of exercise during each session in week 1, 35 min in week 2 and 40-45 min weeks 3-8 with a 5 min cool down period.
Receives: Other: Aerobic Training
Resistance TrainingExperimentalParticipants will undergo a supervised resistance training program in accordance with established guidelines. Each session will be monitored by a physical therapist or exercise physiologist. Sessions will be carried out 3 times per week, 45 min per session. Muscle strength will be determined once before and once after resistance training by measuring ten repetition maximum (10 RM) for each exercise. Eight exercises (three sets; 8-12 repetitions) will be used on each of the large muscle groups (leg press, leg extension, leg curl, chest press, shoulder extension, biceps curl, abdominal crunch and back extension). In addition, workloads will be progressively increased if the patients can lift the weight more than 12 repetitions.
Receives: Other: Resistance Training

What is being measured

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

  1. Changes in peripheral and central blood pressure

    Measured: Baseline (wk. 0), Pre-training (wk. 8), post- training (wk. 16), post detraining (wk. 24)

Secondary outcomes (2)

  1. Changes in arterial stiffness

    Measured: Baseline (wk. 0), Pre-training (wk. 8), post- training (wk. 16), post detraining (wk. 24)

  2. Changes in endothelial function

    Measured: Baseline (wk. 0), Pre-training (wk. 8), post- training (wk. 16), post detraining (wk. 24)

Timeline

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

  1. First posted10 Jan 2017 (estimated)
  2. Study startOct 2016
  3. Primary completionApr 2023 (estimated)
  4. Study completionApr 2023 (estimated)

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
Parallel groups
Masking
None (open label)
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03016351
Sponsor's protocol ID
2015-1091
Other IDs
R01HL130513-01A1
Acronym
BPVR
Status last verified
Oct 2022
First submitted
6 Jan 2017
Last updated
2 Nov 2022
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Magid D, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER, Moy CS, Mussolino ME, Nichol G, Paynter NP, Schreiner PJ, Sorlie PD, Stein J, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Executive summary: heart disease and stroke statistics--2013 update: a report from the American Heart Association. Circulation. 2013 Jan 1;127(1):143-52. doi: 10.1161/CIR.0b013e318282ab8f. No abstract available.

    PubMed 23283859

  • Ogedegbe G, Tobin JN, Fernandez S, Cassells A, Diaz-Gloster M, Khalida C, Pickering T, Schwartz JE. Counseling African Americans to Control Hypertension: cluster-randomized clinical trial main effects. Circulation. 2014 May 20;129(20):2044-51. doi: 10.1161/CIRCULATIONAHA.113.006650. Epub 2014 Mar 21.

    PubMed 24657991

  • Fields LE, Burt VL, Cutler JA, Hughes J, Roccella EJ, Sorlie P. The burden of adult hypertension in the United States 1999 to 2000: a rising tide. Hypertension. 2004 Oct;44(4):398-404. doi: 10.1161/01.HYP.0000142248.54761.56. Epub 2004 Aug 23.

    PubMed 15326093

  • Zion AS, Bond V, Adams RG, Williams D, Fullilove RE, Sloan RP, Bartels MN, Downey JA, De Meersman RE. Low arterial compliance in young African-American males. Am J Physiol Heart Circ Physiol. 2003 Aug;285(2):H457-62. doi: 10.1152/ajpheart.00497.2002. Epub 2003 May 8.

    PubMed 12738618

  • Kaess BM, Rong J, Larson MG, Hamburg NM, Vita JA, Levy D, Benjamin EJ, Vasan RS, Mitchell GF. Aortic stiffness, blood pressure progression, and incident hypertension. JAMA. 2012 Sep 5;308(9):875-81. doi: 10.1001/2012.jama.10503.

    PubMed 22948697

  • Heffernan KS, Jae SY, Wilund KR, Woods JA, Fernhall B. Racial differences in central blood pressure and vascular function in young men. Am J Physiol Heart Circ Physiol. 2008 Dec;295(6):H2380-7. doi: 10.1152/ajpheart.00902.2008. Epub 2008 Oct 10.

    PubMed 18849329

  • Vita JA. Nitric oxide and vascular reactivity in African American patients with hypertension. J Card Fail. 2003 Oct;9(5 Suppl Nitric Oxide):S199-204; discussion S205-9. doi: 10.1054/s1071-9164(03)00588-8. No abstract available.

    PubMed 14583889

  • Heffernan KS, Fahs CA, Iwamoto GA, Jae SY, Wilund KR, Woods JA, Fernhall B. Resistance exercise training reduces central blood pressure and improves microvascular function in African American and white men. Atherosclerosis. 2009 Nov;207(1):220-6. doi: 10.1016/j.atherosclerosis.2009.03.043. Epub 2009 Apr 5.

    PubMed 19410255

  • Franzoni F, Ghiadoni L, Galetta F, Plantinga Y, Lubrano V, Huang Y, Salvetti G, Regoli F, Taddei S, Santoro G, Salvetti A. Physical activity, plasma antioxidant capacity, and endothelium-dependent vasodilation in young and older men. Am J Hypertens. 2005 Apr;18(4 Pt 1):510-6. doi: 10.1016/j.amjhyper.2004.11.006.

    PubMed 15831361

  • Sato A, Miura H, Liu Y, Somberg LB, Otterson MF, Demeure MJ, Schulte WJ, Eberhardt LM, Loberiza FR, Sakuma I, Gutterman DD. Effect of gender on endothelium-dependent dilation to bradykinin in human adipose microvessels. Am J Physiol Heart Circ Physiol. 2002 Sep;283(3):H845-52. doi: 10.1152/ajpheart.00160.2002.

    PubMed 12181110

  • Williams MR, Westerman RA, Kingwell BA, Paige J, Blombery PA, Sudhir K, Komesaroff PA. Variations in endothelial function and arterial compliance during the menstrual cycle. J Clin Endocrinol Metab. 2001 Nov;86(11):5389-95. doi: 10.1210/jcem.86.11.8013.

    PubMed 11701712

  • Hashimoto M, Akishita M, Eto M, Ishikawa M, Kozaki K, Toba K, Sagara Y, Taketani Y, Orimo H, Ouchi Y. Modulation of endothelium-dependent flow-mediated dilatation of the brachial artery by sex and menstrual cycle. Circulation. 1995 Dec 15;92(12):3431-5. doi: 10.1161/01.cir.92.12.3431.

    PubMed 8521564

  • Ling C, Diaz KM, Kretzschmar J, Feairheller DL, Sturgeon KM, Perkins A, Veerabhadrappa P, Williamson ST, Lee H, Grimm H, Babbitt DM, Brown MD. Chronic aerobic exercise improves blood pressure dipping status in African American nondippers. Blood Press Monit. 2014 Dec;19(6):353-8. doi: 10.1097/MBP.0000000000000075.

    PubMed 25100263

Questions about this trial

What is this clinical trial studying?

A study testing Aerobic Training and Resistance Training in people with Hypertension and Cardiovascular Diseases, run by University of Illinois Chicago 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 4 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 2 Nov 2022. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Laurel Thur, MS (312-355-0277, lathur@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in peripheral and central blood pressure (time frame: Baseline (wk. 0), Pre-training (wk. 8), post- training (wk. 16), post detraining (wk. 24)). 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 NCT03016351, which also lists 13 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 2 Nov 2022.

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