NCT05597033

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 performed in the morning and early evening affects blood pressure and other measures of blood vessel health in postmenopausal females with hypertension.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 27, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

January 9, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2025

Completed
Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

2.5 years

First QC Date

October 25, 2022

Last Update Submit

January 14, 2026

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Nocturnal systolic blood pressure (BP)

    Reduction in systolic nocturnal BP (exercise-control)

    24 hours

Secondary Outcomes (3)

  • Early post-exercise hypotension

    30 minutes

  • Endothelial function

    24 hours

  • Microvascular function

    24 hours

Other Outcomes (1)

  • Ambulatory blood pressure

    24 hours

Study Arms (2)

Morning (AM)

EXPERIMENTAL

Before 10 A.M.

Behavioral: ExerciseBehavioral: Control

Evening (PM)

EXPERIMENTAL

After 4 P.M.

Behavioral: ExerciseBehavioral: Control

Interventions

ControlBEHAVIORAL

seated rest

Evening (PM)Morning (AM)
ExerciseBEHAVIORAL

walking and handgrip exercise

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michigan State University

East Lansing, Michigan, 48824, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Exercise

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

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
Associate Professor

Study Record Dates

First Submitted

October 25, 2022

First Posted

October 27, 2022

Study Start

January 9, 2023

Primary Completion

June 24, 2025

Study Completion

June 24, 2025

Last Updated

January 15, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)