Exercise and Vascular Function in Postmenopausal Females with Hypertension

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Behavioral: Exercise; Behavioral: Control

• Registration Number: NCT05597033
• Lead Sponsor: Michigan State University

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.

Study Timeline

• Study First Submitted: 2022-10-25
• Study First Submitted QC: 2022-10-25
• Study First Posted: 2022-10-27
• Study Start: 2023-01-09
• Primary Completion: 2024-08-15
• Study Completion: 2024-08-31
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Evening (PM)	Exercise	After 4 P.M.
Morning (AM)	Control	Before 10 A.M.
Evening (PM)	Control	After 4 P.M.
Morning (AM)	Exercise	Before 10 A.M.

Primary Outcome Measures

Name	Time	Method
Nocturnal systolic blood pressure (BP)	24 hours	Reduction in systolic nocturnal BP (exercise-control)

Secondary Outcome Measures

Name	Time	Method
Early post-exercise hypotension	30 minutes	Post-exercise systolic BP (exercise - control)
Microvascular function	24 hours	Rapid onset vasodilation of the popliteal artery
Endothelial function	24 hours	Flow mediated dilation of the brachial artery

Trial Locations

Locations (1)

Michigan State University; 🇺🇸 East Lansing, Michigan, United States