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Completed

NCT Number: NCT03780309

Postexercise Hypotension and Exercise Adherence

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.

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Key information

Conditions

Hypertension Autonomic Nervous System Diseases Cardiovascular Diseases Hypotension Nervous System Diseases Orthostatic Intolerance Post-Exercise Hypotension Primary Dysautonomias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise Self-Monitoring

Behavioral

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

Blood Pressure Self-Monitoring

Behavioral

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

Primary outcomes

  1. Exercise Adherence

    Time frame: 12 weeks

    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%).

  2. Blood Pressure Response to Exercise Training

    Time frame: 12 weeks

    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.

  3. Blood Pressure Response to Each Exercise Training Session

    Time frame: 12 weeks

    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')

  4. Relative Change in Blood Pressure From Baseline for Each Exercise Session

    Time frame: 12 weeks

    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.

  5. Reliability of Postexercise Hypotension

    Time frame: 12 weeks

    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)

  6. Time Course of Change in the Magnitude of Postexercise Hypotension

    Time frame: 12 wk

    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.

Secondary outcomes

  1. Exercise Training Characteristics: Frequency

    Time frame: 12 weeks

    Exercise training frequency (d/wk) was recorded for supervised, unsupervised, and supervised plus unsupervised exercise training over the course of 12wk.

  2. Exercise Training Characteristics: Intensity

    Time frame: 12 weeks

    Exercise training intensity (%heart rate reserve) was recorded for supervised, unsupervised, and supervised plus unsupervised exercise training over the course of 12wk.

  3. Exercise Training Characteristics: Time

    Time frame: 12 weeks

    Exercise training time (min) was recorded for supervised, unsupervised, and supervised plus unsupervised exercise training over the course of 12wk.

  4. Exercise Training Characteristics: Type

    Time frame: 12 weeks

    Exercise training type (treadmill, cycle ergometer, elliptical) was recorded for unsupervised, and supervised plus unsupervised exercise training over the course of 12wk.

  5. Integrated social-cognitive predictor of exercise

    Time frame: 12 weeks

    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).

  6. Self Reported Physical activity

    Time frame: 12 weeks

    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).

  7. Dietary Intake

    Time frame: 12 weeks

    Participants were asked to maintain their usual lifestyle habits throughout study participation and were administered a validated questionnaire to assess dietary intake (kcal/d).

  8. Salt Intake

    Time frame: 12 weeks

    Participants were asked to maintain their usual lifestyle habits throughout study participation and were administered a validated questionnaire to assess salt intake (mg/d).

  9. Antihypertensive Medication Adherence.

    Time frame: 12 weeks

    Participants taking antihypertensive medication were administered a validated questionnaire to assess antihypertensive medication adherence (%).

Sponsors and collaborators

Lead sponsor

University of Connecticut

Other

Collaborators

  • Hartford Hospital

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 19, 2018
Registry last updated
May 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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