Postexercise Hypotension and Exercise Adherence

NCT03780309 | Completed

• 1 other identifier: H15-277HHC
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypertension

Keywords

antihypertensive lifestyle therapy; positive outcome expectations; postexercise hypotension; self-efficacy; self-management

Outcome Measures

Primary Outcomes (6)

• 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%).

  12 weeks

• Blood Pressure Response to Exercise Training

  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.

  12 weeks

• Blood Pressure Response to Each Exercise Training Session

  In the sub study analysis, the difference in post- minus pre-exercise resting BP from three weekly exercise sessions per participant for each week of training was calculated for both SBP and DBP (in units of 'mmHg')

  12 weeks

• Relative Change in Blood Pressure From Baseline for Each Exercise Session

  The relative percent change in BP for each exercise session was calculated as post- minus pre-exercise BP divided by pre-exercise BP x 100%, for each exercise training session for both SBP and DBP. A negative percent change in SBP and/or DBP from baseline was deemed that postexercise hypotension occurred.

  12 weeks

• Reliability of Postexercise Hypotension

  To quantify the reliability of postexercise hypotension, RMANCOVA and GRMANCOVA adjusted for pre-exercise BP derived the between-participant and measurement error variability that were used to calculate the intraclass correlation coefficient (unit-less)

  12 weeks

• Time Course of Change in the Magnitude of Postexercise Hypotension

  The Akaike Information Criterion (unit-less) was calculated to compare the goodness-of-fit of the postexercise hypotension models for each week of training and to determine the week of exercise training after which the the magnitude of reductions in SBP and DBP ceased to differ week-to-week.

  12 wk

Secondary Outcomes (9)

• Exercise Training Characteristics: Frequency

  12 weeks

• Exercise Training Characteristics: Intensity

  12 weeks

• Exercise Training Characteristics: Time

  12 weeks

• Exercise Training Characteristics: Type

  12 weeks

• Integrated social-cognitive predictor of exercise

  12 weeks

Study Arms (2)

EXERCISE

ACTIVE COMPARATOR

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

Behavioral: Exercise Self-Monitoring

EXERCISE+PEH

EXPERIMENTAL

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

Behavioral: Exercise Self-Monitoring; Behavioral: Blood Pressure Self-Monitoring

Interventions

Exercise Self-Monitoring BEHAVIORAL

Participants engaged in exercise self-monitoring utilizing a traditional calendar recording method and heart rate monitor.

EXERCISE; EXERCISE+PEH

Blood Pressure Self-Monitoring BEHAVIORAL

Participants engaged in blood pressure self-monitoring by measuring blood pressure twice daily and before and after exercise.

EXERCISE+PEH

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Connecticut: lead
• Hartford Hospital: collaborator

MeSH Terms

Conditions

Hypertension; Post-Exercise Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Hypotension

Study Officials

• Linda S Pescatello, PhD

  University of Connecticut

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Board of Trustees Distinguished Professor

Study Record Dates

• First Submitted: December 11, 2018
• First Posted: December 19, 2018
• Study Start: October 28, 2016
• Primary Completion: May 1, 2018
• Study Completion: May 29, 2018
• Last Updated: May 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: All IPD data will be available upon request with no time limit.
• Access Criteria: All IPD data will be shared and emailed to whoever requests it.