Back to resultsAM vs PM Exercise Training
Primary Purpose
Hypertension
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
6 weeks of exercise training (Pre-training)
6 weeks of exercise training (Post-training)
Sponsored by
About this trial
This is an interventional treatment trial for 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
Sites / Locations
- Michigan State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Morning (AM)
Evening (PM)
Arm Description
Exercise starting before 10:01 AM
Exercise starting after 3:59 PM
Outcomes
Primary Outcome Measures
Nocturnal systolic blood pressure (BP)
Change in systolic nocturnal BP (Pre-training - Post-training)
Secondary Outcome Measures
Endothelial function
Change in flow mediated dilation of the brachial artery (Post-training - Pre-training)
Microvascular function
Change in rapid onset vasodilation of the popliteal artery
Ambulatory blood pressure
Change in systolic and diastolic BPs over a 24-hr period (Pre-training - Post-training)
Arterial stiffness
Change in carotid femoral pulse wave velocity (Pre-training - Post-training)
Full Information
NCT ID
NCT06042439
First Posted
September 6, 2023
Last Updated
September 19, 2023
Sponsor
Michigan State University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT06042439
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
June 2026 (Anticipated)
Study Completion Date
July 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Michigan State University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
79 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Morning (AM)
Arm Type
Experimental
Arm Description
Exercise starting before 10:01 AM
Arm Title
Evening (PM)
Arm Type
Experimental
Arm Description
Exercise starting after 3:59 PM
Intervention Type
Behavioral
Intervention Name(s)
6 weeks of exercise training (Pre-training)
Intervention Description
handgrip and treadmill walking 4 days per week
Intervention Type
Behavioral
Intervention Name(s)
6 weeks of exercise training (Post-training)
Intervention Description
handgrip and treadmill walking 4 days per week
Primary Outcome Measure Information:
Title
Nocturnal systolic blood pressure (BP)
Description
Change in systolic nocturnal BP (Pre-training - Post-training)
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Endothelial function
Description
Change in flow mediated dilation of the brachial artery (Post-training - Pre-training)
Time Frame
6 weeks
Title
Microvascular function
Description
Change in rapid onset vasodilation of the popliteal artery
Time Frame
6 weeks
Title
Ambulatory blood pressure
Description
Change in systolic and diastolic BPs over a 24-hr period (Pre-training - Post-training)
Time Frame
6 weeks
Title
Arterial stiffness
Description
Change in carotid femoral pulse wave velocity (Pre-training - Post-training)
Time Frame
6 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jill Slade, PhD
Phone
5178843351
Email
jslade@msu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Katharine Currie, PhD
Phone
517-432-4073
Email
curriek4@msu.edu
Facility Information:
Facility Name
Michigan State University
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48824
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jill Slade, PhD
Phone
517-884-3351
Email
jslade@msu.edu
First Name & Middle Initial & Last Name & Degree
Katharine Currie, PhD
Phone
517-432-4073
Email
curriek4@msu.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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AM vs PM Exercise Training
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