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.
COMPLETED
NA
68 participants
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)
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
| 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.
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|---|---|
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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
| 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.
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|---|---|
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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
| 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.
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|---|---|
|
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
| 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.
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|---|---|
|
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-exerciseSeated 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
| 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.
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|---|---|
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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-exerciseSeated 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
| 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 visitPopulation: 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
| 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.
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|---|---|
|
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 visitPopulation: 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
| 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 visitPopulation: 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
| 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 visitPopulation: 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
| 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
PM CON
PM EX
Study Enrollment
AM CON
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place