- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06702930
Exercise Timing on the Morning Blood Pressure Surge
The Effects of Morning vs. Evening High-intensity Interval Exercise on the Magnitude of the Morning Blood Pressure Surge
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Introductory Visit:
Participants came in for 4 visits. The first visit was an introductory visit where chronotype, eligibility for exercise, and anthropometrics were measured. This was followed by a maximal incremental exercise test to determine aerobic capacity (i.e., V̇O2peak) on a cycle ergometer, and instrumentation of an ambulatory blood pressure monitor for familiarization during daily activities and sleep.
Intervention Visits:
Three intervention visits (control, morning exercise, and evening exercise) were completed. The order was randomized using and each visit was separated by a minimum of 36 hours. Each intervention visit began by obtaining the participant's resting blood pressure and heart rate and ended with the instrumentation of the ambulatory blood pressure monitor. No exercise was performed during the control visit. The morning exercise visit included a bout of high-intensity interval exercise between 8-10 am and the evening exercise visit included a bout of high-intensity interval exercise between 5-7 pm. The high-intensity interval exercise protocol consisted of a light intensity, 3-minute warm-up at 15% peak power followed by ten 1-minute work intervals at 80% of peak power, with each interval separated by 1-minute rest intervals at 15% peak power. A 3-minute cool down was performed at 15% peak power.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Guelph, Ontario, Canada, N1G 2W1
- University of Guelph
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion:
- Between 18-50 years of age.
- No history of known disease.
- None smokers.
- No use of chronic medications other than oral contraceptives.
Exclusion:
- <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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
No exercise was performed and ambulatory blood pressure was assessed for 24 hours.
|
|
|
Experimental: Morning high-intensity interval exercise
High-intensity interval exercise was performed between 8-10 am and ambulatory blood pressure was assessed for 24 hours after.
|
High-intensity interval exercise was performed between 8-10 am
|
|
Experimental: Evening high-intensity interval exercise
High-intensity interval exercise was performed between 5-7 pm and ambulatory blood pressure was assessed for 24 hours after.
|
High-intensity interval exercise was performed between 5-7 pm
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Morning blood pressure surge
Time Frame: Through study completion, an average of 4 weeks.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Nighttime blood pressure dip
Time Frame: Through study completion, an average of 4 weeks.
|
The percent difference between daytime blood pressure (average of all blood pressure readings when participants reported being awake) and nighttime blood pressure (average of all blood pressure readings when the participant reported being asleep).
|
Through study completion, an average of 4 weeks.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Philip Millar, PhD, University of Guelph
- Study Director: Julian Bommarito, MSc, University of Guelph
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-07-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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