An interventional study of Exercise Self-Monitoring and Blood Pressure Self-Monitoring in Hypertension, sponsored by University of Connecticut. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-13.
Sponsored by University of Connecticut · Not applicable, Interventional, and Treatment
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.
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.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's enrollment of 24 is below the median of 100 across 4,575 interventional studies indexed under Hypertension.
Browse Hypertension studies →University of Connecticut is the lead sponsor of 135 studies on the registry; 19 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants participated in a the exercise training program and engaged in exercise self-monitoring.
Behavioral: 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).
Behavioral: Exercise Self-Monitoring · Behavioral: Blood Pressure Self-Monitoring
Participants engaged in exercise self-monitoring utilizing a traditional calendar recording method and heart rate monitor.
Participants engaged in blood pressure self-monitoring by measuring blood pressure twice daily and before and after exercise.
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%).
Time frame: 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.
Time frame: 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')
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 12 wk
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.
Time frame: 12 weeks
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.
Time frame: 12 weeks
Exercise Training Characteristics: Time
Exercise training time (min) was recorded for supervised, unsupervised, and supervised plus unsupervised exercise training over the course of 12wk.
Time frame: 12 weeks
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.
Time frame: 12 weeks
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).
Time frame: 12 weeks
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).
Time frame: 12 weeks
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).
Time frame: 12 weeks
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).
Time frame: 12 weeks
Antihypertensive Medication Adherence.
Participants taking antihypertensive medication were administered a validated questionnaire to assess antihypertensive medication adherence (%).
Time frame: 12 weeks
No study locations are listed for this record.
Plan to share: Yes — All IPD data will be made available upon request.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
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.
No publications or documents are linked to this record.
Ran from Oct 2016 to primary completion in May 2018, 18 months.
Of 1,403 non-industry interventional studies with no phase under Hypertension, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's 18 months is below that.
Counting every sponsor, half of 1,498 studies reached it within 23 months; a quarter within 10 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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