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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 : November 2, 2020
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Shane Phillips, PT, PhD, University of Illinois at Chicago

Tracking Information
First Submitted Date  ICMJE January 6, 2017
First Posted Date  ICMJE January 10, 2017
Last Update Posted Date November 2, 2020
Study Start Date  ICMJE October 2016
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 6, 2017)
Changes in peripheral and central blood pressure [ Time Frame: Baseline (wk. 0), Pre-training (wk. 8), post- training (wk. 16), post detraining (wk. 24) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 6, 2017)
  • Changes in arterial stiffness [ Time Frame: Baseline (wk. 0), Pre-training (wk. 8), post- training (wk. 16), post detraining (wk. 24) ]
  • Changes in endothelial function [ Time Frame: Baseline (wk. 0), Pre-training (wk. 8), post- training (wk. 16), post detraining (wk. 24) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Improving Blood Pressure and Cardiovascular Risk With Resistance Exercise in African Americans
Official Title  ICMJE Improving Blood Pressure and Cardiovascular Risk With Resistance Exercise in African Americans
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.
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).

  2. 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.

  3. 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.

  4. 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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypertension
  • Cardiovascular Diseases
  • Vascular Diseases
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Aerobic Training
  • 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.
    Intervention: Other: Resistance Training
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 6, 2017)
140
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Laurel Thur, MS 312-355-0277 lathur@uic.edu
Contact: Shane Phillips, PhD 312-355-0277 shanep@uic.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03016351
Other Study ID Numbers  ICMJE 2015-1091
R01HL130513-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Shane Phillips, PT, PhD, University of Illinois at Chicago
Study Sponsor  ICMJE University of Illinois at Chicago
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Shane Phillips, PhD University of Illinois at Chicago
PRS Account University of Illinois at Chicago
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP