Clinical trial NCT03780309: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: antihypertensive lifestyle therapy
positive outcome expectations
postexercise hypotension
self-efficacy
self-management
Lead sponsor: University of Connecticut
Sponsor class: OTHER
Collaborators: name: Hartford Hospital
First posted: 2018-12-19
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Exercise Adherence
timeFrame: 12 weeks
measure: Blood Pressure Response to Exercise Training
timeFrame: 12 weeks
measure: Blood Pressure Response to Each Exercise Training Session
timeFrame: 12 weeks
measure: Relative Change in Blood Pressure From Baseline for Each Exercise Session
timeFrame: 12 weeks
measure: Reliability of Postexercise Hypotension
timeFrame: 12 weeks
measure: Time Course of Change in the Magnitude of Postexercise Hypotension
timeFrame: 12 wk
Secondary outcomes:
measure: Exercise Training Characteristics: Frequency
timeFrame: 12 weeks
measure: Exercise Training Characteristics: Intensity
timeFrame: 12 weeks
measure: Exercise Training Characteristics: Time
timeFrame: 12 weeks
measure: Exercise Training Characteristics: Type
timeFrame: 12 weeks
measure: Integrated social-cognitive predictor of exercise
timeFrame: 12 weeks
measure: Self Reported Physical activity
timeFrame: 12 weeks
measure: Dietary Intake
timeFrame: 12 weeks
measure: Salt Intake
timeFrame: 12 weeks
measure: Antihypertensive Medication Adherence.
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Connecticut
name: Linda S Pescatello, PhD
role: PRINCIPAL_INVESTIGATOR
References: