Trial Outcomes & Findings for Exercise and Vascular Function in Postmenopausal Females With Hypertension (NCT NCT05597033)

NCT ID: NCT05597033

Last Updated: 2026-08-28

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

68 participants

Primary outcome timeframe

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)

Results posted on

2026-08-28

Participant Flow

Individuals were recruited from the local community using word of mouth, email advertisements and flyers posted in medical clinics.

Our statistical analysis plan required 42 participants; we enrolled 68 to account for excluding people who did not meet the blood pressure inclusion criteria or who did not pass the exercise stress test. Once the inclusion/exclusion criteria and negative stress test were confirmed, each participant completed the experimental visits.

Participant milestones

Participant milestones
Measure
Experimental Visits
Each participant completed the following four experimental visits: Morning Control (AM CON): assessments in the morning; visit did not include exercise. Morning Exercise (AM EX): assessments in the morning; visit included a standardized exercise bout. Evening Control (PM CON): assessments in the evening; visit did not include exercise. Evening Exercise (PM EX): assessments in the evening; visit included a standardized exercise bout.
Overall Study
STARTED
68
Overall Study
COMPLETED
42
Overall Study
NOT COMPLETED
26

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Exercise and Vascular Function in Postmenopausal Females With Hypertension

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Experimental Visits
n=42 Participants
Each participant completed the following four experimental visits: Morning Control: assessments in the morning; visit did not include exercise. Morning Exercise: assessments in the morning; visit included a standardized exercise bout. Evening Control: assessments in the evening; visit did not include exercise. Evening Exercise: assessments in the evening; visit included a standardized exercise bout.
Age, Customized
Age
67 years
STANDARD_DEVIATION 7 • n=31 Participants
Sex: Female, Male
Female
42 Participants
n=31 Participants
Sex: Female, Male
Male
0 Participants
n=31 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=31 Participants
Race (NIH/OMB)
Asian
1 Participants
n=31 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=31 Participants
Race (NIH/OMB)
Black or African American
14 Participants
n=31 Participants
Race (NIH/OMB)
White
27 Participants
n=31 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=31 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=31 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
n=31 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
41 Participants
n=31 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=31 Participants
Use of anti-hypertensive medications
None
5 Participants
n=31 Participants
Use of anti-hypertensive medications
AM routine only
17 Participants
n=31 Participants
Use of anti-hypertensive medications
PM routine only
8 Participants
n=31 Participants
Use of anti-hypertensive medications
AM and PM routine
12 Participants
n=31 Participants
Body mass index
30.9 kg/m2
STANDARD_DEVIATION 5.3 • n=31 Participants

PRIMARY outcome

Timeframe: 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)

Population: AM CON = values obtained after the morning control (no-exercise) visit; AM EX = values obtained after the morning exercise visit; PM CON = values obtained after the evening control (no-exercise) visit; PM EX = values obtained after the evening exercise visit.

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.

Outcome measures

Outcome measures
Measure
Experimental Visits
n=42 Participants
Each participant completed the following four experimental visits: Morning Control: assessments in the morning; visit did not include exercise. Morning Exercise: assessments in the morning; visit included a standardized exercise bout. Evening Control: assessments in the evening; visit did not include exercise. Evening Exercise: assessments in the evening; visit included a standardized exercise bout.
Nocturnal Systolic Blood Pressure
Evening Exercise
118 mmHg
Standard Deviation 14
Nocturnal Systolic Blood Pressure
Evening Control
119 mmHg
Standard Deviation 12
Nocturnal Systolic Blood Pressure
Morning Control
118 mmHg
Standard Deviation 13
Nocturnal Systolic Blood Pressure
Morning Exercise
121 mmHg
Standard Deviation 15

PRIMARY outcome

Timeframe: 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)

Population: AM CON = values obtained after the morning control (no-exercise) visit; AM EX = values obtained after the morning exercise visit; PM CON = values obtained after the evening control (no-exercise) visit; PM EX = values obtained after the evening exercise visit.

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.

Outcome measures

Outcome measures
Measure
Experimental Visits
n=42 Participants
Each participant completed the following four experimental visits: Morning Control: assessments in the morning; visit did not include exercise. Morning Exercise: assessments in the morning; visit included a standardized exercise bout. Evening Control: assessments in the evening; visit did not include exercise. Evening Exercise: assessments in the evening; visit included a standardized exercise bout.
Nocturnal Diastolic Blood Pressure
Morning Control
64 mmHg
Standard Deviation 10
Nocturnal Diastolic Blood Pressure
Morning Exercise
65 mmHg
Standard Deviation 11
Nocturnal Diastolic Blood Pressure
Evening Control
64 mmHg
Standard Deviation 10
Nocturnal Diastolic Blood Pressure
Evening Exercise
64 mmHg
Standard Deviation 10

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Experimental Visits
n=42 Participants
Each participant completed the following four experimental visits: Morning Control: assessments in the morning; visit did not include exercise. Morning Exercise: assessments in the morning; visit included a standardized exercise bout. Evening Control: assessments in the evening; visit did not include exercise. Evening Exercise: assessments in the evening; visit included a standardized exercise bout.
Early (In-lab) Post-exercise Hypotension (Systolic Blood Pressure)
AM CON
135 mmHg
Standard Deviation 13
Early (In-lab) Post-exercise Hypotension (Systolic Blood Pressure)
AM Pre-EX
136 mmHg
Standard Deviation 15
Early (In-lab) Post-exercise Hypotension (Systolic Blood Pressure)
AM Post-EX
124 mmHg
Standard Deviation 15
Early (In-lab) Post-exercise Hypotension (Systolic Blood Pressure)
PM CON
131 mmHg
Standard Deviation 16
Early (In-lab) Post-exercise Hypotension (Systolic Blood Pressure)
PM Pre-EX
141 mmHg
Standard Deviation 16
Early (In-lab) Post-exercise Hypotension (Systolic Blood Pressure)
PM Post-EX
126 mmHg
Standard Deviation 15

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Experimental Visits
n=42 Participants
Each participant completed the following four experimental visits: Morning Control: assessments in the morning; visit did not include exercise. Morning Exercise: assessments in the morning; visit included a standardized exercise bout. Evening Control: assessments in the evening; visit did not include exercise. Evening Exercise: assessments in the evening; visit included a standardized exercise bout.
Early (In-lab) Post-exercise Hypotension (Diastolic Blood Pressure)
AM CON
78 mmHg
Standard Deviation 9
Early (In-lab) Post-exercise Hypotension (Diastolic Blood Pressure)
AM Pre-EX
78 mmHg
Standard Deviation 11
Early (In-lab) Post-exercise Hypotension (Diastolic Blood Pressure)
AM Post-EX
74 mmHg
Standard Deviation 11
Early (In-lab) Post-exercise Hypotension (Diastolic Blood Pressure)
PM CON
75 mmHg
Standard Deviation 9
Early (In-lab) Post-exercise Hypotension (Diastolic Blood Pressure)
PM Pre-EX
78 mmHg
Standard Deviation 10
Early (In-lab) Post-exercise Hypotension (Diastolic Blood Pressure)
PM Post-EX
75 mmHg
Standard Deviation 11

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

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

Population: AM CON = values obtained after the morning control (no-exercise) visit; AM EX = values obtained after the morning exercise visit; PM CON = values obtained after the evening control (no-exercise) visit; PM EX = values obtained after the evening exercise 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.

Outcome measures

Outcome measures
Measure
Experimental Visits
n=42 Participants
Each participant completed the following four experimental visits: Morning Control: assessments in the morning; visit did not include exercise. Morning Exercise: assessments in the morning; visit included a standardized exercise bout. Evening Control: assessments in the evening; visit did not include exercise. Evening Exercise: assessments in the evening; visit included a standardized exercise bout.
24-hr Systolic Blood Pressure
AM CON
131 mmHg
Standard Deviation 10
24-hr Systolic Blood Pressure
AM EX
133 mmHg
Standard Deviation 11
24-hr Systolic Blood Pressure
PM CON
133 mmHg
Standard Deviation 11
24-hr Systolic Blood Pressure
PM EX
133 mmHg
Standard Deviation 10

OTHER_PRE_SPECIFIED outcome

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

Population: AM CON = values obtained after the morning control (no-exercise) visit; AM EX = values obtained after the morning exercise visit; PM CON = values obtained after the evening control (no-exercise) visit; PM EX = values obtained after the evening exercise 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.

Outcome measures

Outcome measures
Measure
Experimental Visits
n=42 Participants
Each participant completed the following four experimental visits: Morning Control: assessments in the morning; visit did not include exercise. Morning Exercise: assessments in the morning; visit included a standardized exercise bout. Evening Control: assessments in the evening; visit did not include exercise. Evening Exercise: assessments in the evening; visit included a standardized exercise bout.
24-hr Diastolic Blood Pressure
AM CON
73 mmHg
Standard Deviation 9
24-hr Diastolic Blood Pressure
AM EX
75 mmHg
Standard Deviation 10
24-hr Diastolic Blood Pressure
PM CON
74 mmHg
Standard Deviation 9
24-hr Diastolic Blood Pressure
PM EX
75 mmHg
Standard Deviation 8

OTHER_PRE_SPECIFIED outcome

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

Population: AM CON = values obtained after the morning control (no-exercise) visit; AM EX = values obtained after the morning exercise visit; PM CON = values obtained after the evening control (no-exercise) visit; PM EX = values obtained after the evening exercise 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.

Outcome measures

Outcome measures
Measure
Experimental Visits
n=42 Participants
Each participant completed the following four experimental visits: Morning Control: assessments in the morning; visit did not include exercise. Morning Exercise: assessments in the morning; visit included a standardized exercise bout. Evening Control: assessments in the evening; visit did not include exercise. Evening Exercise: assessments in the evening; visit included a standardized exercise bout.
Awake Systolic Blood Pressure
AM CON
137 mmHg
Standard Deviation 10
Awake Systolic Blood Pressure
AM EX
138 mmHg
Standard Deviation 11
Awake Systolic Blood Pressure
PM CON
140 mmHg
Standard Deviation 12
Awake Systolic Blood Pressure
PM EX
139 mmHg
Standard Deviation 10

OTHER_PRE_SPECIFIED outcome

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

Population: AM CON = values obtained after the morning control (no-exercise) visit; AM EX = values obtained after the morning exercise visit; PM CON = values obtained after the evening control (no-exercise) visit; PM EX = values obtained after the evening exercise 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.

Outcome measures

Outcome measures
Measure
Experimental Visits
n=42 Participants
Each participant completed the following four experimental visits: Morning Control: assessments in the morning; visit did not include exercise. Morning Exercise: assessments in the morning; visit included a standardized exercise bout. Evening Control: assessments in the evening; visit did not include exercise. Evening Exercise: assessments in the evening; visit included a standardized exercise bout.
Awake Diastolic Blood Pressure
AM CON
78 mmHg
Standard Deviation 9
Awake Diastolic Blood Pressure
AM EX
79 mmHg
Standard Deviation 9
Awake Diastolic Blood Pressure
PM CON
79 mmHg
Standard Deviation 9
Awake Diastolic Blood Pressure
PM EX
79 mmHg
Standard Deviation 8

Adverse Events

AM EX

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

PM CON

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

PM EX

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Study Enrollment

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

AM CON

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Katharine Currie

Michigan State University

Phone: 517-355-4730

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place