Post-Exercise HypotensionNCT06702930
Exercise Timing on the Morning Blood Pressure Surge
A study testing Morning high-intensity interval exercise and Evening high-intensity interval exercise in people with Post-Exercise Hypotension and Ambulatory Blood Pressure Monitoring, run by University of Guelph at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-Exercise Hypotension, Ambulatory Blood Pressure Monitoring, High-intensity Interval Exercise
- What is being tested?
- Morning high-intensity interval exercise and Evening high-intensity interval exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteCanada
- Study dates
- 28 Jan 2020to 8 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between 18-50 years of age.
- No history of known disease.
- None smokers.
- No use of chronic medications other than oral contraceptives.
Who cannot join
- <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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Post-Exercise Hypotension, Ambulatory Blood Pressure Monitoring, High-intensity Interval Exercise
- Being tested
- Morning high-intensity interval exercise, Evening high-intensity interval exercise
- Keywords
- Ambulatory blood pressure monitoring, Morning blood pressure surge, High-intensity interval exercise, Post-exercise hypotension
- Medical subject headings
- Post-Exercise Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morning high-intensity interval exerciseOther
High-intensity interval exercise was performed between 8-10 am
Evening high-intensity interval exerciseOther
High-intensity interval exercise was performed between 5-7 pm
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Evening high-intensity interval exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Through study completion, an average of 4 weeks.
Secondary outcomes (1)
Nighttime blood pressure dip
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).
Measured: Through study completion, an average of 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start28 Jan 2020
- Primary completion8 Jun 2023
- Study completion8 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-Exercise HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guelph
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philip Millar, University of Guelph
- Investigators
- Julian Bommarito, MSc, Study director, University of GuelphPhilip Millar, PhD, Principal investigator, University of Guelph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06702930
- Sponsor's protocol ID
- 19-07-002
- Status last verified
- Nov 2024
- First submitted
- 19 Nov 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Publications
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.
PubMed 39689295
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Morning vs. Evening High-intensity Interval Exercise on the Magnitude of the Morning Blood Pressure Surge
- ClinicalTrials.gov ID
- NCT06702930
- Acronym / sponsor ID
- 19-07-002
- Conditions
- Post-Exercise Hypotension, Ambulatory Blood Pressure Monitoring, High-intensity Interval Exercise
- Keywords
- Ambulatory blood pressure monitoring, Morning blood pressure surge, High-intensity interval exercise, Post-exercise hypotension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of GuelphUniversity, hospital or other
- Study start
- 28 Jan 2020 (actual)
- Primary completion
- 8 Jun 2023 (actual)
- Study completion
- 8 Jun 2023 (actual)
- First posted
- 25 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No exercise was performed and ambulatory blood pressure was assessed for 24 hours. |
| Morning high-intensity interval exercise | Experimental | Other: Morning high-intensity interval exerciseHigh-intensity interval exercise was performed between 8-10 am and ambulatory blood pressure was assessed for 24 hours after. |
| Evening high-intensity interval exercise | Experimental | Other: Evening high-intensity interval exerciseHigh-intensity interval exercise was performed between 5-7 pm and ambulatory blood pressure was assessed for 24 hours after. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Between 18-50 years of age.
- No history of known disease.
- None smokers.
- No use of chronic medications other than oral contraceptives.
Key exclusion criteria (6 listed)
- <18 years of age.
- >50 years of age.
- Cardiovascular disease.
- Metabolic disease.
- History of smoking (within the past 3 months).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Morning high-intensity interval exerciseHigh-intensity interval exercise was performed between 8-10 am | Other | Morning high-intensity interval exercise |
| Evening high-intensity interval exerciseHigh-intensity interval exercise was performed between 5-7 pm | Other | Evening high-intensity interval exercise |
Primary outcome
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).
1 secondary outcome
Nighttime blood pressure dip
Time frame: Through study completion, an average of 4 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Derived from this study: PubMed 39689295Bommarito 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.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julian Bommarito, MSc study director
University of Guelph
Philip Millar, PhD principal investigator
University of Guelph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morning high-intensity interval exercise and Evening high-intensity interval exercise in people with Post-Exercise Hypotension and Ambulatory Blood Pressure Monitoring, run by University of Guelph at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morning blood pressure surge (time frame: Through study completion, an average of 4 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06702930, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.