AM vs PM Exercise Training

NCT ID: NCT06042439

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-11
• Study Completion Date: 2027-07-01

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Morning (AM)

Exercise starting before 10:01 AM

Group Type: EXPERIMENTAL

6 weeks of exercise training (Pre-training)

Intervention Type: BEHAVIORAL

handgrip and treadmill walking 4 days per week

6 weeks of exercise training (Post-training)

Intervention Type: BEHAVIORAL

handgrip and treadmill walking 4 days per week

Evening (PM)

Exercise starting after 3:59 PM

Group Type: EXPERIMENTAL

6 weeks of exercise training (Pre-training)

Intervention Type: BEHAVIORAL

handgrip and treadmill walking 4 days per week

6 weeks of exercise training (Post-training)

Intervention Type: BEHAVIORAL

handgrip and treadmill walking 4 days per week

Interventions

6 weeks of exercise training (Pre-training)

handgrip and treadmill walking 4 days per week

Intervention Type: BEHAVIORAL

6 weeks of exercise training (Post-training)

handgrip and treadmill walking 4 days per week

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Michigan State University

OTHER

Sponsor Role: lead

Responsible Party

Katharine Currie

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Michigan State University

East Lansing, Michigan, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jill Slade, PhD

Role: CONTACT

jslade@msu.edu

5178843351

Katharine Currie, PhD

Role: CONTACT

curriek4@msu.edu

517-432-4073

Facility Contacts

Jill Slade, PhD

Role: primary

jslade@msu.edu

517-884-3351

Katharine Currie, PhD

Role: backup

curriek4@msu.edu

517-432-4073

Other Identifiers

1R01HL164575-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01HL164575-Study3

Identifier Type: -

Identifier Source: org_study_id