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

Sponsor

University of Illinois at Chicago (Other)

Overall Status

Recruiting

CT.gov ID

NCT03016351

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

140

Enrollment

Location

Arms

Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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.

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).

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.

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.

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 Design

Study Type:

Interventional

Anticipated 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 :

Oct 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

Changes in peripheral and central blood pressure [Baseline (wk. 0), Pre-training (wk. 8), post- training (wk. 16), post detraining (wk. 24)]

Secondary Outcome Measures

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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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