Hypertension
Conditions
Brief 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. 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.
Interventions
BEHAVIORALExercise
walking and handgrip exercise
BEHAVIORALControl
seated rest
Sponsors
Michigan State University
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
55 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nocturnal Systolic Blood Pressure | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Early (In-lab) Post-exercise Hypotension (Systolic Blood Pressure) | 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. |
| Early (In-lab) Post-exercise Hypotension (Diastolic Blood Pressure) | 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. |
| Endothelial Function | 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 |
| Microvascular Function | 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. |
Countries
United States
Participant flow
Recruitment details
Individuals were recruited from the local community using word of mouth, email advertisements and flyers posted in medical clinics.
Pre-assignment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized Age | 67 years STANDARD_DEVIATION 7 |
| Body mass index | 30.9 kg/m2 STANDARD_DEVIATION 5.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 41 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 27 Participants |
| Sex: Female, Male Female | 42 Participants |
| Sex: Female, Male Male | 0 Participants |
| Use of anti-hypertensive medications AM and PM routine | 12 Participants |
| Use of anti-hypertensive medications AM routine only | 17 Participants |
| Use of anti-hypertensive medications None | 5 Participants |
| Use of anti-hypertensive medications PM routine only | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 68 | 0 / 42 | 0 / 42 | 0 / 42 | 0 / 42 |
| other Total, other adverse events | 0 / 68 | 0 / 42 | 0 / 42 | 0 / 42 | 0 / 42 |
| serious Total, serious adverse events | 0 / 68 | 0 / 42 | 0 / 42 | 0 / 42 | 0 / 42 |
Outcome results
None listed