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

NCT03016351 | Unknown DMC

• 2 other identifiers: 2015-1091R01HL130513-01A1
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Hypertension; Cardiovascular Diseases; Vascular Diseases

Keywords

Hypertension; Exercise; African Americans; Arterial Function; Arterial Stiffness

Outcome Measures

Primary Outcomes (1)

• Changes in peripheral and central blood pressure

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

Secondary Outcomes (2)

• Changes in arterial stiffness

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

• Changes in endothelial function

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

Study Arms (2)

Aerobic Training

EXPERIMENTAL

Participants 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.

Other: Aerobic Training

Resistance Training

EXPERIMENTAL

Participants 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.

Other: Resistance Training

Interventions

Aerobic Training OTHER

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.

Aerobic Training

Resistance Training OTHER

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 Training

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

RECRUITING

Related Publications (13)

• 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.

  PMID: 23283859 RESULT

• 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.

  PMID: 24657991 RESULT

• 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.

  PMID: 15326093 RESULT

• 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.

  PMID: 12738618 RESULT

• 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.

  PMID: 22948697 RESULT

• 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.

  PMID: 18849329 RESULT

• 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.

  PMID: 14583889 RESULT

• 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.

  PMID: 19410255 RESULT

• 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.

  PMID: 15831361 RESULT

• 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.

  PMID: 12181110 RESULT

• 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.

  PMID: 11701712 RESULT

• 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.

  PMID: 8521564 RESULT

• 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.

  PMID: 25100263 RESULT

MeSH Terms

Conditions

Hypertension; Cardiovascular Diseases; Vascular Diseases; Motor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Shane Phillips, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurel Thur, MS

CONTACT

312-355-0277; lathur@uic.edu

Shane Phillips, PhD

CONTACT

312-355-0277; shanep@uic.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 6, 2017
• First Posted: January 10, 2017
• Study Start: October 1, 2016
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: November 2, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)