HypertensionNCT06042439
AM vs PM Exercise Training
A study testing 6 weeks of exercise training (Pre-training) and 6 weeks of exercise training (Post-training) 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?
- 6 weeks of exercise training (Pre-training) and 6 weeks of exercise training (Post-training)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2024to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Show all 16Show fewer
- Evening shift work
- uncontrolled thyroid disorder
- 2 or more falls in the last year
- Anemia within 3 months of enrollment
- Parkinson's disease
- Dementia
- Unstable angina
- Acute pulmonary embolus or infarction
- Acute myocarditis or pericarditis
- Acute aortic dissection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Michigan State University
East Lansing, Michigan, 48824
Jill Slade, PhD, 517-884-3351, jslade@msu.edu
Katharine Currie, PhD, 517-432-4073, curriek4@msu.edu
About this study
Official title: Effects of AM vs. PM Exercise Training on Blood Pressure and Vascular Health 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 training 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 effects of morning and evening exercise training on BP and other measures of vascular function in older females with hypertension.
- Conditions
- Hypertension
- Being tested
- 6 weeks of exercise training (Pre-training), 6 weeks of exercise training (Post-training)
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6 weeks of exercise training (Pre-training)Behavioural
handgrip and treadmill walking 4 days per week
6 weeks of exercise training (Post-training)Behavioural
handgrip and treadmill walking 4 days per week
| Study group | Role | What they receive |
|---|---|---|
| Morning (AM) | Experimental | Exercise starting before 10:01 AM Receives: Behavioral: 6 weeks of exercise training (Pre-training); Behavioral: 6 weeks of exercise training (Post-training) |
| Evening (PM) | Experimental | Exercise starting after 3:59 PM Receives: Behavioral: 6 weeks of exercise training (Pre-training); Behavioral: 6 weeks of exercise training (Post-training) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nocturnal systolic blood pressure (BP)
Change in systolic nocturnal BP (Pre-training - Post-training)
Measured: 6 weeks
Secondary outcomes (4)
Endothelial function
Change in flow mediated dilation of the brachial artery (Post-training - Pre-training)
Measured: 6 weeks
Microvascular function
Change in rapid onset vasodilation of the popliteal artery
Measured: 6 weeks
Ambulatory blood pressure
Change in systolic and diastolic BPs over a 24-hr period (Pre-training - Post-training)
Measured: 6 weeks
Arterial stiffness
Change in carotid femoral pulse wave velocity (Pre-training - Post-training)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start11 Jun 2024
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 79 participants (estimated)
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
- NCT06042439
- Sponsor's protocol ID
- R01HL164575-Study3
- Other IDs
- 1R01HL164575-01A1
- Status last verified
- Sep 2026
- First submitted
- 6 Sep 2023
- Last updated
- 1 Oct 2026
- Results posted
- No
- 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 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of AM vs. PM Exercise Training on Blood Pressure and Vascular Health in Postmenopausal Females With Hypertension
- ClinicalTrials.gov ID
- NCT06042439
- Acronym / sponsor ID
- R01HL164575-Study3
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 79 participants (estimated)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 11 Jun 2024 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 18 Sep 2023 (actual)
- Results
- Not posted in the source record
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 training 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 effects of morning and evening exercise training 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: 6 weeks of exercise training (Pre-training), Behavioral: 6 weeks of exercise training (Post-training)Exercise starting before 10:01 AM |
| Evening (PM) | Experimental | Behavioral: 6 weeks of exercise training (Pre-training), Behavioral: 6 weeks of exercise training (Post-training)Exercise starting after 3:59 PM |
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 (16 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 |
|---|---|---|
| 6 weeks of exercise training (Pre-training)handgrip and treadmill walking 4 days per week | Behavioural | Evening (PM), Morning (AM) |
| 6 weeks of exercise training (Post-training)handgrip and treadmill walking 4 days per week | Behavioural | Evening (PM), Morning (AM) |
Primary outcome
Nocturnal systolic blood pressure (BP)
Time frame: 6 weeks
Change in systolic nocturnal BP (Pre-training - Post-training)
4 secondary outcomes
Endothelial function
Time frame: 6 weeks
Microvascular function
Time frame: 6 weeks
Ambulatory blood pressure
Time frame: 6 weeks
Arterial stiffness
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 6 weeks of exercise training (Pre-training) and 6 weeks of exercise training (Post-training) 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 16 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: looking for participants now, as of the sponsor's last update on 1 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jill Slade, PhD (5178843351, jslade@msu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nocturnal systolic blood pressure (BP) (time frame: 6 weeks). 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 1 Oct 2026.