AM vs PM Exercise Training

• Sponsor: Michigan State University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06042439
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Enrollment: 79
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 45
• Patients Per Site Per Month: 1.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Behavioral: 6 weeks of exercise training (Pre-training); Behavioral: 6 weeks of exercise training (Post-training)	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 79 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effects of AM vs. PM Exercise Training on Blood Pressure and Vascular Health in Postmenopausal Females With Hypertension
• Anticipated Study Start Date: Oct 1, 2023
• Anticipated Primary Completion Date: Jun 1, 2026
• Anticipated Study Completion Date: Jul 1, 2027

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Nocturnal systolic blood pressure (BP) [6 weeks]

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

Secondary Outcome Measures

1. Endothelial function [6 weeks]

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

2. Microvascular function [6 weeks]

   Change in rapid onset vasodilation of the popliteal artery

3. Ambulatory blood pressure [6 weeks]

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

4. Arterial stiffness [6 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years to 80 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Michigan State University	East Lansing	Michigan	United States	48824

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Katharine Currie, Assistant Professor, Michigan State University
• ClinicalTrials.gov Identifier: NCT06042439
• Other Study ID Numbers: R01HL164575-Study3; 1R01HL164575-01A1
• First Posted: Sep 18, 2023
• Last Update Posted: Sep 21, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypertension

Study Results

No Results Posted as of Sep 21, 2023