Postexercise Hypotension and Exercise Adherence

NCT ID: NCT03780309

Last Updated: 2024-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-28
• Study Completion Date: 2018-05-29

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

EXERCISE

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

Group Type: ACTIVE_COMPARATOR

Exercise Self-Monitoring

Intervention Type: BEHAVIORAL

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

EXERCISE+PEH

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

Group Type: EXPERIMENTAL

Exercise Self-Monitoring

Intervention Type: BEHAVIORAL

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

Blood Pressure Self-Monitoring

Intervention Type: BEHAVIORAL

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

Interventions

Exercise Self-Monitoring

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

Intervention Type: BEHAVIORAL

Blood Pressure Self-Monitoring

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hartford Hospital

OTHER

Sponsor Role: collaborator

University of Connecticut

OTHER

Sponsor Role: lead

Responsible Party

Linda Pescatello

Board of Trustees Distinguished Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Linda S Pescatello, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Connecticut

Other Identifiers

H15-277HHC

Identifier Type: -

Identifier Source: org_study_id