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

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ClinicalTrials.gov Identifier: NCT03016351
Recruitment Status : Recruiting
First Posted : January 10, 2017
Last Update Posted : January 10, 2017
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Shane Phillips, PT, PhD, University of Illinois at Chicago

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.

Condition or disease Intervention/treatment Phase
Hypertension Cardiovascular Diseases Vascular Diseases Other: Aerobic Training Other: Resistance Training Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Blood Pressure and Cardiovascular Risk With Resistance Exercise in African Americans
Study Start Date : October 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Aerobic Training
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
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.

Experimental: Resistance Training
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
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.




Primary Outcome Measures :
  1. Changes in peripheral and central blood pressure [ Time Frame: Baseline (wk. 0), Pre-training (wk. 8), post- training (wk. 16), post detraining (wk. 24) ]

Secondary Outcome Measures :
  1. Changes in arterial stiffness [ Time Frame: Baseline (wk. 0), Pre-training (wk. 8), post- training (wk. 16), post detraining (wk. 24) ]
  2. Changes in endothelial function [ Time Frame: Baseline (wk. 0), Pre-training (wk. 8), post- training (wk. 16), post detraining (wk. 24) ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Currently abusing alcohol or illicit drugs
  • Unreliability as a study subject, in the opinion of the Investigator
  • Lidocaine allergy
  • Amenorrhea
  • Postmenopausal women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03016351


Contacts
Contact: Laurel Thur, MS 312-996-8980 lathur@uic.edu
Contact: Shane Phillips, PhD 312-355-0277 shanep@uic.edu

Locations
United States, Illinois
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Laurel Thur, MS    312-996-8980    lathur@uic.edu   
Contact: Shane Phillips, PhD    312-355-0277    shanep@uic.edu   
Principal Investigator: Shane Phillips, PhD         
Sponsors and Collaborators
University of Illinois at Chicago
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Shane Phillips, PhD University of Illinois at Chicago

Publications of Results:

Responsible Party: Shane Phillips, PT, PhD, Professor, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT03016351     History of Changes
Other Study ID Numbers: 2015-1091
R01HL130513-01A1 ( U.S. NIH Grant/Contract )
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: January 10, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Shane Phillips, PT, PhD, University of Illinois at Chicago:
Hypertension
Exercise
African Americans
Arterial Function
Arterial Stiffness

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases