Clinical Trials Directory

Trials / Completed

CompletedNCT03780309

Postexercise Hypotension and Exercise Adherence

Using the Immediate Blood Pressure Benefits of Exercise to Improve Exercise Adherence Among Adults With Hypertension

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
24 (actual)
Sponsor
University of Connecticut · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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.

Detailed description

A sub-study following the completion of the PULSE clinical trial investigated the reliability and time course of change of PEH during the 12-week exercise training program. Participants (n = 10) were PEH responders from the EXERCISE + PEH control arm who underwent 12 wk of supervised aerobic exercise training, 40 min/session at moderate-to-vigorous intensity for 3 d/wk. BP was assessed via a home BP monitor. PEH was calculated as post- minus pre-exercise BP for 36 sessions. To quantify the reliability of PEH, 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 (ICC). The Akaike Information Criterion (AIC) compared the goodness-of-fit of the PEH models for each week of training.

Conditions

Interventions

TypeNameDescription
BEHAVIORALExercise Self-MonitoringParticipants engaged in exercise self-monitoring utilizing a traditional calendar recording method and heart rate monitor.
BEHAVIORALBlood Pressure Self-MonitoringParticipants engaged in blood pressure self-monitoring by measuring blood pressure twice daily and before and after exercise.

Timeline

Start date
2016-10-28
Primary completion
2018-05-01
Completion
2018-05-29
First posted
2018-12-19
Last updated
2024-05-13

Source: ClinicalTrials.gov record NCT03780309. Inclusion in this directory is not an endorsement.