Clinical trial NCT06042439: AM vs PM Exercise Training
Official title: Effects of AM vs. PM Exercise Training on Blood Pressure and Vascular Health in Postmenopausal Females With Hypertension
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Lead sponsor: Michigan State University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-09-18
Enrollment: 79
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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
* 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

Primary outcomes:
measure: Nocturnal systolic blood pressure (BP)
timeFrame: 6 weeks
Secondary outcomes:
measure: Endothelial function
timeFrame: 6 weeks
measure: Microvascular function
timeFrame: 6 weeks
measure: Ambulatory blood pressure
timeFrame: 6 weeks
measure: Arterial stiffness
timeFrame: 6 weeks
Other outcomes:
Locations:
city: East Lansing
country: United States
facility: Michigan State University
state: Michigan
Study officials:
References: