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NCT Number: NCT06042439

AM vs PM Exercise Training

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.

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Key information

Age range

55 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

6 weeks of exercise training (Pre-training)

Behavioral

handgrip and treadmill walking 4 days per week

6 weeks of exercise training (Post-training)

Behavioral

handgrip and treadmill walking 4 days per week

Primary outcomes

  1. Nocturnal systolic blood pressure (BP)

    Time frame: 6 weeks

    Change in systolic nocturnal BP (Pre-training - Post-training)

Secondary outcomes

  1. Endothelial function

    Time frame: 6 weeks

    Change in flow mediated dilation of the brachial artery (Post-training - Pre-training)

  2. Microvascular function

    Time frame: 6 weeks

    Change in rapid onset vasodilation of the popliteal artery

  3. Ambulatory blood pressure

    Time frame: 6 weeks

    Change in systolic and diastolic BPs over a 24-hr period (Pre-training - Post-training)

  4. Arterial stiffness

    Time frame: 6 weeks

    Change in carotid femoral pulse wave velocity (Pre-training - Post-training)

Study contacts

Contact information is provided by the study sponsor or research team.

Jill Slade, PhD

CONTACT

[email protected]

5178843351

Katharine Currie, PhD

CONTACT

[email protected]

517-432-4073

Sponsors and collaborators

Lead sponsor

Michigan State University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Effects of AM vs. PM Exercise Training on Blood Pressure and Vascular Health in Postmenopausal Females With Hypertension

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Sep 18, 2023
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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