HypertensionNCT05597033
Exercise and Vascular Function in Postmenopausal Females With Hypertension
A study testing Exercise in people with Hypertension, run by Michigan State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 to 80 years, women only
- Conditions the study is for
- Hypertension
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2023to 24 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Michigan State University
East Lansing, Michigan, 48824
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- Exercise, Control
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
walking and handgrip exercise
ControlBehavioural
seated rest
| Study group | Role | What they receive |
|---|---|---|
| Morning (AM) | Experimental | Before 10 A.M. Receives: Behavioral: Exercise; Behavioral: Control |
| Evening (PM) | Experimental | After 4 P.M. Receives: Behavioral: Exercise; Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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 outcomes (4)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start9 Jan 2023
- Primary completion24 Jun 2025
- Study completion24 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Katharine Currie, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05597033
- Sponsor's protocol ID
- R56HL164575-Study1
- Other IDs
- R56HL164575-01
- Status last verified
- Aug 2026
- First submitted
- 25 Oct 2022
- Last updated
- 28 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Exercise Time of Day on Blood Pressure and Vascular Function
- ClinicalTrials.gov ID
- NCT05597033
- Acronym / sponsor ID
- R56HL164575-Study1
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 24 Jun 2025 (actual)
- Study completion
- 24 Jun 2025 (actual)
- First posted
- 27 Oct 2022 (actual)
- Results
- Posted 28 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morning (AM) | Experimental | Behavioral: Exercise, Behavioral: ControlBefore 10 A.M. |
| Evening (PM) | Experimental | Behavioral: Exercise, Behavioral: ControlAfter 4 P.M. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercisewalking and handgrip exercise | Behavioural | Evening (PM), Morning (AM) |
| Controlseated rest | Behavioural | Evening (PM), Morning (AM) |
Primary outcome
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.
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.
4 secondary outcomes
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
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
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Hypertension, run by Michigan State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.