Exercise and Vascular Function in Postmenopausal Females With Hypertension

Sponsor
Michigan State University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05597033
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
47
1
2
15
3.1

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 your 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 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
  • Behavioral: Exercise
  • Behavioral: Control
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 effect of evening exercise on BP and other measures of vascular function in older females with hypertension.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
47 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Effects of Exercise Time of Day on Blood Pressure and Vascular Function
Anticipated Study Start Date :
Nov 15, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Feb 15, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Morning-AM

Before 10AM

Behavioral: Exercise
walking and handgrip exercise

Behavioral: Control
seated rest

Experimental: Evening-PM

After 4PM

Behavioral: Exercise
walking and handgrip exercise

Behavioral: Control
seated rest

Outcome Measures

Primary Outcome Measures

  1. Nocturnal systolic BP [24 hours]

    Reduction in systolic nocturnal BP (exercise-control)

Secondary Outcome Measures

  1. Early post-exercise hypotension [30 minutes]

    Post-exercise systolic BP (exercise - control)

  2. Endothelial function [24 hours]

    Flow mediated dilation of the brachial artery

  3. Microvascular function [24 hours]

    Rapid onset vasodilation of the popliteal artery

Other Outcome Measures

  1. Ambulatory blood pressure [24 hours]

    Systolic and diastolic BPs over a 24-hr period

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 and diastolic BP equal to and greater than 80 mmHg

  • 55-80 years old

  • Post-menopausal female

  • Early or intermediate chronotype

  • 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 vaping

  • Evening shift work

  • Evening chronotype

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:
NCT05597033
Other Study ID Numbers:
  • R56HL164575-Study1
  • R56HL164575-01
First Posted:
Oct 27, 2022
Last Update Posted:
Oct 27, 2022
Last Verified:
Oct 1, 2022
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:

Study Results

No Results Posted as of Oct 27, 2022