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
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
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
NCT ID
NCT03780309
First Posted
December 11, 2018
Last Updated
December 17, 2018
Sponsor
University of Connecticut
Collaborators
Hartford Hospital
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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