NCT06042439

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
13mo left

Started Jun 2024

Typical duration for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Jun 2024Jul 2027

First Submitted

Initial submission to the registry

September 6, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 18, 2023

Completed
9 months until next milestone

Study Start

First participant enrolled

June 11, 2024

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

September 25, 2025

Status Verified

September 1, 2025

Enrollment Period

3.1 years

First QC Date

September 6, 2023

Last Update Submit

September 24, 2025

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Nocturnal systolic blood pressure (BP)

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

    6 weeks

Secondary Outcomes (4)

  • Endothelial function

    6 weeks

  • Microvascular function

    6 weeks

  • Ambulatory blood pressure

    6 weeks

  • Arterial stiffness

    6 weeks

Study Arms (2)

Morning (AM)

EXPERIMENTAL

Exercise starting before 10:01 AM

Behavioral: 6 weeks of exercise training (Pre-training)Behavioral: 6 weeks of exercise training (Post-training)

Evening (PM)

EXPERIMENTAL

Exercise starting after 3:59 PM

Behavioral: 6 weeks of exercise training (Pre-training)Behavioral: 6 weeks of exercise training (Post-training)

Interventions

6 weeks of exercise training (Pre-training)BEHAVIORAL

handgrip and treadmill walking 4 days per week

Evening (PM)Morning (AM)
6 weeks of exercise training (Post-training)BEHAVIORAL

handgrip and treadmill walking 4 days per week

Evening (PM)Morning (AM)

Eligibility Criteria

Age55 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • years old
  • Post-menopausal female
  • Able to walk without assistance

You may not qualify if:

  • 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
  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michigan State University

East Lansing, Michigan, 48824, United States

RECRUITING

MeSH Terms

Conditions

Hypertension

Interventions

Exercise

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Jill Slade, PhD

CONTACT

5178843351jslade@msu.edu

Katharine Currie, PhD

CONTACT

517-432-4073curriek4@msu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 6, 2023

First Posted

September 18, 2023

Study Start

June 11, 2024

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

September 25, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)