Postexercise Hypotension and Exercise Adherence

Overview

Sedentary (n=24) adults ≥18 yr with elevated BP to established hypertension were enrolled into this randomized clinical trial entitled, 'Blood Pressure UtiLizing Self-Monitoring after Exercise study or PULSE'. Participants were randomly assigned to either an exercise only (EXERCISE; n=12) or exercise plus BP self-monitoring (EXERCISE+PEH) (n=12) group. All participants participated in a 12 wk supervised moderate intensity aerobic exercise training program 40 min/d for 3 d/wk. In addition, they were encouraged to exercise at home ≥30 min/d for 1-2 d/wk. All participants self-monitored exercise with a traditional calendar recording method and heart rate (HR) monitor. In addition to traditional exercise self-monitoring (EXERCISE), individuals in the EXERCISE+PEH group were given a home BP monitor to assess home BP twice daily (in the morning upon awakening and in the evening) and prior to and after voluntary home exercise sessions. Resting BP, peak oxygen consumption (VO2peak), physical activity, dietary and salt intake, and antihypertensive medication adherence were measured before and after the 12 wk supervised exercise training program. In addition, integrated social-cognitive predictors of exercise that included questionnaires on exercise self-efficacy, barriers self-efficacy, outcome expectations for exercise, exercise intention, and affective responses to exercise were measured before and after the 12 wk supervised exercise training program. Four weeks following the completion of exercise training, self-reported exercise levels were assessed during a telephone interview in both groups. Among EXERCISE+PEH only, self-monitoring of BP was also self-reported during this telephone interview.

Full Title of Study: “Using the Immediate Blood Pressure Benefits of Exercise to Improve Exercise Adherence Among Adults With Hypertension”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: May 1, 2018

Interventions

  • Behavioral: Exercise Self-Monitoring
    • Participants engaged in exercise self-monitoring utilizing a traditional calendar recording method and heart rate monitor.
  • Behavioral: Blood Pressure Self-Monitoring
    • Participants engaged in blood pressure self-monitoring by measuring blood pressure twice daily and before and after exercise.

Arms, Groups and Cohorts

  • Active Comparator: EXERCISE
    • Participants participated in a the exercise training program and engaged in exercise self-monitoring.
  • Experimental: EXERCISE+PEH
    • Participants participated in the exercise training program and engaged in exercise self-monitoring and blood pressure self-monitoring (daily and before and after exercise).

Clinical Trial Outcome Measures

Primary Measures

  • Exercise Adherence
    • Time Frame: 12 weeks
    • Exercise adherence to the 12 wk supervised portion of the aerobic exercise training program was calculated as the percent of supervised exercise sessions completed divided by the total number of supervised sessions possible (# of supervised sessions performed ÷ total number of possible supervised sessions X 100%). In this calculation, the total number of possible sessions was calculated as: 3 supervised exercise training days per wk for 12 wk = 36 sessions with a maximum possible adherence of 100% (e.g., 36÷36 X 100% =100%).
  • Blood Pressure
    • Time Frame: 12 weeks
    • The BP response to aerobic exercise training was calculated in two ways and in units ‘mmHg’: (1) in the laboratory (post training resting BP – pre training resting BP) during the control visits (Visits 1 or 2 vs. Visit 4 or 5); and (2) under ambulatory conditions (post training ambulatory BP – pre training ambulatory BP) following the control visits (Visits 1 or 2 vs. Visit 4 or 5) over the awake, sleep, and 19 hr.

Secondary Measures

  • Exercise Training Characteristics: Frequency
    • Time Frame: 12 weeks
    • Exercise training frequency (d/wk) was recorded for supervised, unsupervised, and supervised plus unsupervised exercise training over the course of 12wk.
  • Exercise Training Characteristics: Intensity
    • Time Frame: 12 weeks
    • Exercise training intensity (%heart rate reserve) was recorded for supervised, unsupervised, and supervised plus unsupervised exercise training over the course of 12wk.
  • Exercise Training Characteristics: Time
    • Time Frame: 12 weeks
    • Exercise training time (min) was recorded for supervised, unsupervised, and supervised plus unsupervised exercise training over the course of 12wk.
  • Exercise Training Characteristics: Type
    • Time Frame: 12 weeks
    • Exercise training type (treadmill, cycle ergometer, elliptical) was recorded for unsupervised, and supervised plus unsupervised exercise training over the course of 12wk.
  • Integrated social-cognitive predictor of exercise
    • Time Frame: 12 weeks
    • Participants were administered a validated questionnaire packet to assess whether EXERCISE and EXERCISE+PEH self-monitoring favorably modulated measures of integrated social-cognitive predictors of exercise (unitless).
  • Self Reported Physical activity
    • Time Frame: 12 weeks
    • Participants were asked to maintain their usual lifestyle habits throughout study participation and were administered a validated questionnaire to assess self reported. physical activity (min).
  • Dietary Intake
    • Time Frame: 12 weeks
    • Participants were asked to maintain their usual lifestyle habits throughout study participation and were administered a validated questionnaire to assess dietary intake (kcal/d).
  • Salt Intake
    • Time Frame: 12 weeks
    • Participants were asked to maintain their usual lifestyle habits throughout study participation and were administered a validated questionnaire to assess salt intake (mg/d).
  • Antihypertensive Medication Adherence.
    • Time Frame: 12 weeks
    • Participants taking antihypertensive medication were administered a validated questionnaire to assess antihypertensive medication adherence (%).

Participating in This Clinical Trial

Inclusion Criteria

  • ≥18 yr
  • SBP ≥130 mmHg or DBP ≥80 mmHg or taking antihypertensive medication regardless of BP with a SBP <160 mmHg and DBP <100 mmHg
  • Free of diagnosed cardiovascular, pulmonary, renal, metabolic, or other chronic diseases or depression
  • Non-smokers for at least 6 mo prior to entry
  • Consumed <2 alcoholic drinks daily
  • Physically inactive defined as engaging in formal exercise ≤ 2d/wk.

Exclusion Criteria

  • Taking medications that influenced blood pressure such as inhaled or oral steroids, nonsteroidal anti-inflammatory agents, aspirin, and nutritional supplements with the exception of a 1-a-day vitamin, cold medications, and herbal supplements
  • Osteoarthritis and orthopedic problems that compromised ability to exercise.
  • Past medical history of cancer-related lymphedema
  • Seeking to gain or lose weight
  • Pregnant, lactating, or planning to become pregnant.
  • Hormone-altering contraception administered in a bolus

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Connecticut
  • Collaborator
    • Hartford Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Linda Pescatello, Board of Trustees Distinguished Professor – University of Connecticut
  • Overall Official(s)
    • Linda S Pescatello, PhD, Principal Investigator, University of Connecticut

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