NCT06702930

Brief Summary

The goal of this clinical trial was to assess the effects of morning vs. evening high-intensity interval exercise on the magnitude of the morning blood pressure surge in young healthy adults. The main questions it aimed to answer were:

  • Does the timing of high-intensity interval exercise modulate the magnitude of the morning blood pressure surge?
  • Do sex differences exist? Participants came in and completed a bout of high-intensity interval exercise in the morning (8-10 am) and evening (5-7 pm) as well as a no exercise control, and ambulatory blood pressure was assessed for 24 hours afterwards.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

January 28, 2020

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2023

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 19, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 25, 2024

Completed
Last Updated

November 27, 2024

Status Verified

November 1, 2024

Enrollment Period

3.4 years

First QC Date

November 19, 2024

Last Update Submit

November 24, 2024

Conditions

Keywords

Ambulatory blood pressure monitoringMorning blood pressure surgeHigh-intensity interval exercisePost-exercise hypotension

Outcome Measures

Primary Outcomes (1)

  • Morning blood pressure surge

    The difference between morning blood pressure (the mean of the 4 blood pressure readings after awakening) and sleep-trough blood pressure (the mean of the lowest blood pressure during sleep and two adjacent blood pressure readings).

    Through study completion, an average of 4 weeks.

Secondary Outcomes (1)

  • Nighttime blood pressure dip

    Through study completion, an average of 4 weeks.

Study Arms (3)

Control

NO INTERVENTION

No exercise was performed and ambulatory blood pressure was assessed for 24 hours.

Morning high-intensity interval exercise

EXPERIMENTAL

High-intensity interval exercise was performed between 8-10 am and ambulatory blood pressure was assessed for 24 hours after.

Other: Morning high-intensity interval exercise

Evening high-intensity interval exercise

EXPERIMENTAL

High-intensity interval exercise was performed between 5-7 pm and ambulatory blood pressure was assessed for 24 hours after.

Other: Evening high-intensity interval exercise

Interventions

High-intensity interval exercise was performed between 8-10 am

Morning high-intensity interval exercise

High-intensity interval exercise was performed between 5-7 pm

Evening high-intensity interval exercise

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Between 18-50 years of age.
  • No history of known disease.
  • None smokers.
  • No use of chronic medications other than oral contraceptives.

You may not qualify if:

  • \<18 years of age.
  • \>50 years of age.
  • Cardiovascular disease.
  • Metabolic disease.
  • History of smoking (within the past 3 months).
  • Chronic medications (other than oral contraceptives).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Guelph

Guelph, Ontario, N1G 2W1, Canada

Location

Related Publications (1)

  • Bommarito J, Millar PJ. The effects of morning versus evening high-intensity interval exercise on the magnitude of the morning blood pressure surge. Appl Physiol Nutr Metab. 2025 Jan 1;50:1-11. doi: 10.1139/apnm-2024-0449.

MeSH Terms

Conditions

Post-Exercise Hypotension

Condition Hierarchy (Ancestors)

Orthostatic IntolerancePrimary DysautonomiasAutonomic Nervous System DiseasesNervous System DiseasesHypotensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Julian Bommarito, MSc

    University of Guelph

    STUDY DIRECTOR
  • Philip Millar, PhD

    University of Guelph

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 19, 2024

First Posted

November 25, 2024

Study Start

January 28, 2020

Primary Completion

June 8, 2023

Study Completion

June 8, 2023

Last Updated

November 27, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

Shared Documents
STUDY PROTOCOL
Time Frame
After publication; unending.
Access Criteria
Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.

Locations