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Postexercise Hypotension and Exercise Adherence

Primary Purpose

Hypertension

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exercise Self-Monitoring
Blood Pressure Self-Monitoring
Sponsored by
University of Connecticut
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring antihypertensive lifestyle therapy, positive outcome expectations, postexercise hypotension, self-efficacy, self-management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    EXERCISE

    EXERCISE+PEH

    Arm Description

    Participants participated in a the exercise training program and engaged in exercise self-monitoring.

    Participants participated in the exercise training program and engaged in exercise self-monitoring and blood pressure self-monitoring (daily and before and after exercise).

    Outcomes

    Primary Outcome Measures

    Exercise Adherence
    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
    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 Outcome Measures

    Exercise Training Characteristics: Frequency
    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
    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
    Exercise training time (min) was recorded for supervised, unsupervised, and supervised plus unsupervised exercise training over the course of 12wk.
    Exercise Training Characteristics: Type
    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
    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
    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
    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
    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.
    Participants taking antihypertensive medication were administered a validated questionnaire to assess antihypertensive medication adherence (%).

    Full Information

    First Posted
    December 11, 2018
    Last Updated
    December 17, 2018
    Sponsor
    University of Connecticut
    Collaborators
    Hartford Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03780309
    Brief Title
    Postexercise Hypotension and Exercise Adherence
    Official Title
    Using the Immediate Blood Pressure Benefits of Exercise to Improve Exercise Adherence Among Adults With Hypertension
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    October 28, 2016 (Actual)
    Primary Completion Date
    May 1, 2018 (Actual)
    Study Completion Date
    May 29, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Connecticut
    Collaborators
    Hartford Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertension
    Keywords
    antihypertensive lifestyle therapy, positive outcome expectations, postexercise hypotension, self-efficacy, self-management

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    24 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    EXERCISE
    Arm Type
    Active Comparator
    Arm Description
    Participants participated in a the exercise training program and engaged in exercise self-monitoring.
    Arm Title
    EXERCISE+PEH
    Arm Type
    Experimental
    Arm Description
    Participants participated in the exercise training program and engaged in exercise self-monitoring and blood pressure self-monitoring (daily and before and after exercise).
    Intervention Type
    Behavioral
    Intervention Name(s)
    Exercise Self-Monitoring
    Intervention Description
    Participants engaged in exercise self-monitoring utilizing a traditional calendar recording method and heart rate monitor.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Blood Pressure Self-Monitoring
    Intervention Description
    Participants engaged in blood pressure self-monitoring by measuring blood pressure twice daily and before and after exercise.
    Primary Outcome Measure Information:
    Title
    Exercise Adherence
    Description
    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%).
    Time Frame
    12 weeks
    Title
    Blood Pressure
    Description
    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.
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Exercise Training Characteristics: Frequency
    Description
    Exercise training frequency (d/wk) was recorded for supervised, unsupervised, and supervised plus unsupervised exercise training over the course of 12wk.
    Time Frame
    12 weeks
    Title
    Exercise Training Characteristics: Intensity
    Description
    Exercise training intensity (%heart rate reserve) was recorded for supervised, unsupervised, and supervised plus unsupervised exercise training over the course of 12wk.
    Time Frame
    12 weeks
    Title
    Exercise Training Characteristics: Time
    Description
    Exercise training time (min) was recorded for supervised, unsupervised, and supervised plus unsupervised exercise training over the course of 12wk.
    Time Frame
    12 weeks
    Title
    Exercise Training Characteristics: Type
    Description
    Exercise training type (treadmill, cycle ergometer, elliptical) was recorded for unsupervised, and supervised plus unsupervised exercise training over the course of 12wk.
    Time Frame
    12 weeks
    Title
    Integrated social-cognitive predictor of exercise
    Description
    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).
    Time Frame
    12 weeks
    Title
    Self Reported Physical activity
    Description
    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).
    Time Frame
    12 weeks
    Title
    Dietary Intake
    Description
    Participants were asked to maintain their usual lifestyle habits throughout study participation and were administered a validated questionnaire to assess dietary intake (kcal/d).
    Time Frame
    12 weeks
    Title
    Salt Intake
    Description
    Participants were asked to maintain their usual lifestyle habits throughout study participation and were administered a validated questionnaire to assess salt intake (mg/d).
    Time Frame
    12 weeks
    Title
    Antihypertensive Medication Adherence.
    Description
    Participants taking antihypertensive medication were administered a validated questionnaire to assess antihypertensive medication adherence (%).
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Linda S Pescatello, PhD
    Organizational Affiliation
    University of Connecticut
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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