Ignite Creation Date:
2024-05-06 @ 12:31 PM
Last Modification Date:
2024-10-26 @ 1:00 PM
Study NCT ID:
NCT03780309
Status:
COMPLETED
Last Update Posted:
2024-05-13
First Post:
2018-12-11
Brief Title:
Postexercise Hypotension and Exercise Adherence
Sponsor:
University of Connecticut
Organization:
University of Connecticut
Study Overview
Official Title:
Using the Immediate Blood Pressure Benefits of Exercise to Improve Exercise Adherence Among Adults With Hypertension
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Sedentary n24 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 n12 or exercise plus BP self-monitoring EXERCISEPEH n12 group All participants participated in a 12 wk supervised moderate intensity aerobic exercise training program 40 mind for 3 dwk In addition they were encouraged to exercise at home 30 mind for 1-2 dwk 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 EXERCISEPEH 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 EXERCISEPEH 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 minsession at moderate-to-vigorous intensity for 3 dwk 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None