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Completed

NCT Number: NCT05597033

Exercise and Vascular Function in Postmenopausal Females With Hypertension

The treatment of high blood pressure, or hypertension, is multifaceted and can include pharmacological therapies (i.e., medications) and lifestyle modifications such as physical activity. Chronotherapy, which describes timing of a treatment with the body's daily rhythms, has recently been used with hypertension medications and has been shown to be effective at lowering blood pressure and reducing the risk of cardiovascular disease events. Specifically, taking medications in the evening was shown to be more effective than morning medication routines. Little information is available about the effectiveness of chronotherapy combined with exercise (i.e., planned physical activity) interventions in older adults with hypertension. The purpose of this study is to examine how exercise performed in the morning and early evening affects blood pressure and other measures of blood vessel health in postmenopausal females with hypertension.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

55 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Michigan State University

East Lansing, Michigan, 48824, United States

About this study

Blood pressure has an internal rhythm associated with the 24-hr clock. Nocturnal blood pressure (BP) is a key contributor to cardiovascular health and may be improved by exercise. Moreover, the time of day of the exercise may be a key factor. This study aims to evaluate the effect of evening exercise on BP and other measures of vascular function in older females with hypertension.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Systolic BP equal to or greater than 130 mmHg without BP medication or greater than 120 mmHg with medication and diastolic blood pressure equal to and greater than 80 mmHg
  • 55-80 years old
  • Post-menopausal female
  • Able to walk without assistance

Exclusion criteria

  • Habitually physically active defined as 150 minutes of moderate-intensity or 75 minutes of vigorous-intensity aerobic physical activity per week
  • Overt pulmonary disease/condition as follows: chronic bronchitis, chronic obstructive pulmonary disease, emphysema, or pulmonary hypertension
  • Cardiometabolic disease/condition as follows: diabetes, heart failure, peripheral arterial disease, stroke, coronary artery disease, renal disease, secondary hypertension, chronic venous insufficiency or deep vein thrombosis within last 6 months
  • Cancer within last 5 years
  • Body mass index >39 kg/m2
  • Current smoking or vape
  • Evening shift work

Treatment and study plan

Exercise

Behavioral

walking and handgrip exercise

Control

Behavioral

seated rest

Primary outcomes

  1. Nocturnal Systolic Blood Pressure

    Time frame: Assessed the evening following each experimental visit (e.g., ~11-12 hours following morning visits and ~2-3 hours following evening visits, depending on their bedtime)

    Nocturnal systolic blood pressure obtained over a 24-hr period following each experimental visit. Measures were taken every 30-60 minutes over a 24-hour period. Asleep time was determined using wrist-worn actigraphy cross-referenced to self-reported sleep diaries. Systolic blood pressure measures during the sleeping (nocturnal) time were averaged and reported.

  2. Nocturnal Diastolic Blood Pressure

    Time frame: Assessed the evening following each experimental visit (e.g., ~11-12 hours following morning visits and ~2-3 hours following evening visits, depending on their bedtime)

    Nocturnal diastolic blood pressure obtained over a 24-hr period following each experimental visit. Measures were taken every 30-60 minutes over a 24-hour period. Asleep time was determined using wrist-worn actigraphy cross-referenced to self-reported sleep diaries. Diastolic blood pressure measures during the sleeping (nocturnal) time were averaged and reported.

Secondary outcomes

  1. Early (In-lab) Post-exercise Hypotension (Systolic Blood Pressure)

    Time frame: Control AM and PM visits: at 30 minutes following the start of quiet seated rest; Exercise AM and PM visits: immediately pre-exercise and at 30-minutes immediately post-exercise

    Seated blood pressures were obtained before (Pre-EX) and for 30-minutes (Post-EX) following the morning (AM) and evening (PM) exercise bouts. On the control (CON) visits, blood pressures were obtained during 30-minutes of quiet seated rest. The lowest value obtained during the CON and Post-EX periods were used for comparison. Within each time of day (AM or PM), Post-EX were compared to Pre-EX and CON.

  2. Early (In-lab) Post-exercise Hypotension (Diastolic Blood Pressure)

    Time frame: Control AM and PM visits: at 30 minutes following the start of quiet seated rest; Exercise AM and PM visits: immediately pre-exercise and at 30-minutes immediately post-exercise

    Seated blood pressures were obtained before (Pre-EX) and for 30-minutes (Post-EX) following the morning (AM) and evening (PM) exercise bouts. On the control (CON) visits, blood pressures were obtained during 30-minutes of quiet seated rest. The lowest value obtained during the CON and Post-EX periods were used for comparison. Within each time of day (AM or PM), Post-EX were compared to Pre-EX and CON.

  3. Endothelial Function

    Time frame: Assessed during a non-exercise control visit (AM CON) and the morning after AM and PM exercise. Post-AM EX assessment occurred ~23 hours post-AM exercise and Post-PM EX assessment occurred ~14 hours post-PM exercise.

    Flow mediated dilation of the brachial artery. Preliminary analysis is complete and results are undergoing verification and finalization. Finalized results are anticipated in 09/2026

  4. Microvascular Function

    Time frame: Assessed during a non-exercise control visit (AM CON) and the morning after AM and PM exercise. Post-AM EX assessment occurred ~23 hours post-AM exercise and Post-PM EX assessment occurred ~14 hours post-PM exercise.

    Rapid onset vasodilation of the popliteal artery. Preliminary analysis is complete and results are undergoing verification and finalization. Finalized results are anticipated in 09/2026.

Other outcomes

  1. 24-hr Systolic Blood Pressure

    Time frame: Assessed for 24 hours following the completion of each experimental visit

    Systolic blood pressure obtained over a 24-hr period following each experimental visit. Measures were taken every 30-60 minutes over a 24-hour period. Systolic blood pressures across the 24-hour period were averaged and reported.

  2. 24-hr Diastolic Blood Pressure

    Time frame: Assessed for 24 hours following the completion of each experimental visit

    Diastolic blood pressure obtained over a 24-hr period following each experimental visit. Measures were taken every 30-60 minutes over a 24-hour period. Diastolic blood pressures across the 24-hour period were averaged and reported.

  3. Awake Systolic Blood Pressure

    Time frame: Assessed for 24 hours following the completion of each experimental visit

    Awake systolic blood pressure obtained over a 24-hr period following each experimental visit. Measures were taken every 30-60 minutes over a 24-hour period. Awake time was determined using wrist-worn actigraphy cross-referenced to self-reported sleep diaries. Systolic blood pressure measures during the awake time were averaged and reported.

  4. Awake Diastolic Blood Pressure

    Time frame: Assessed for 24 hours following the completion of each experimental visit

    Awake diastolic blood pressure obtained over a 24-hr period following each experimental visit. Measures were taken every 30-60 minutes over a 24-hour period. Awake time was determined using wrist-worn actigraphy cross-referenced to self-reported sleep diaries. Diastolic blood pressure measures during the awake time were averaged and reported.

Sponsors and collaborators

Lead sponsor

Michigan State University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

The Effects of Exercise Time of Day on Blood Pressure and Vascular Function

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 27, 2022
Registry last updated
Aug 28, 2026

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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