Exercise and Vascular Function in Postmenopausal Females With Hypertension

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Behavioral: Exercise; Behavioral: Control

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • East Lansing, Michigan, United States, 48824
      • Michigan State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 51 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Morning (AM); Before 10 A.M.	Behavioral: Exercise; walking and handgrip exercise; Behavioral: Control; seated rest
Experimental: Evening (PM); After 4 P.M.	Behavioral: Exercise; walking and handgrip exercise; Behavioral: Control; seated rest

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nocturnal Systolic Blood Pressure	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.	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	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.	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early (In-lab) Post-exercise Hypotension (Systolic Blood Pressure)	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.	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
Early (In-lab) Post-exercise Hypotension (Diastolic Blood Pressure)	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.	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
Endothelial Function	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	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.
Microvascular Function	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.	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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
24-hr Systolic Blood Pressure	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.	Assessed for 24 hours following the completion of each experimental visit
24-hr Diastolic Blood Pressure	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.	Assessed for 24 hours following the completion of each experimental visit
Awake Systolic Blood Pressure	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.	Assessed for 24 hours following the completion of each experimental visit
Awake Diastolic Blood Pressure	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.	Assessed for 24 hours following the completion of each experimental visit

Collaborators and Investigators

• Sponsor: Michigan State University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2023
• Primary Completion (Actual): June 24, 2025
• Study Completion (Actual): June 24, 2025

Study Registration Dates

• First Submitted: October 25, 2022
• First Submitted That Met QC Criteria: October 25, 2022
• First Posted (Actual): October 27, 2022

Study Record Updates

• Last Update Posted (Actual): August 28, 2026
• Last Update Submitted That Met QC Criteria: August 6, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: R56HL164575-Study1; R56HL164575-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No