AM vs PM Exercise Training

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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension
• Intervention / Treatment: Behavioral: 6 weeks of exercise training (Pre-training); Behavioral: 6 weeks of exercise training (Post-training)

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 Type: Interventional
• Enrollment (Estimated): 79
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katharine Currie, PhD; Phone Number: 517-432-4073; Email: curriek4@msu.edu
• Study Contact Backup: Name: Jill Slade, PhD; Phone Number: 5178843351; Email: jslade@msu.edu

Study Locations

• United States
  • Michigan
    • East Lansing, Michigan, United States, 48824
      • Recruiting
      • Michigan State University
      • Contact: Jill Slade, PhD; Phone Number: 517-884-3351; Email: jslade@msu.edu
      • Contact: Katharine Currie, PhD; Phone Number: 517-432-4073; Email: curriek4@msu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Morning (AM); Exercise starting before 10:01 AM	Behavioral: 6 weeks of exercise training (Pre-training); handgrip and treadmill walking 4 days per week; Behavioral: 6 weeks of exercise training (Post-training); handgrip and treadmill walking 4 days per week
Experimental: Evening (PM); Exercise starting after 3:59 PM	Behavioral: 6 weeks of exercise training (Pre-training); handgrip and treadmill walking 4 days per week; Behavioral: 6 weeks of exercise training (Post-training); handgrip and treadmill walking 4 days per week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nocturnal systolic blood pressure (BP)	Change in systolic nocturnal BP (Pre-training - Post-training)	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endothelial function	Change in flow mediated dilation of the brachial artery (Post-training - Pre-training)	6 weeks
Microvascular function	Change in rapid onset vasodilation of the popliteal artery	6 weeks
Ambulatory blood pressure	Change in systolic and diastolic BPs over a 24-hr period (Pre-training - Post-training)	6 weeks
Arterial stiffness	Change in carotid femoral pulse wave velocity (Pre-training - Post-training)	6 weeks

Collaborators and Investigators

• Sponsor: Michigan State University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: September 6, 2023
• First Submitted That Met QC Criteria: September 6, 2023
• First Posted (Actual): September 18, 2023

Study Record Updates

• Last Update Posted (Estimated): September 25, 2025
• Last Update Submitted That Met QC Criteria: September 24, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: R01HL164575-Study3; 1R01HL164575-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No