Hypertension,EssentialDIISCCONCT04103411
Effect of High-Intensity Interval Training Compared to Hydrochlorothiazide on Ambulatory Blood Pressure
A study testing 24h-Ambulatory Blood Pressure in people with Hypertension,Essential and Exercise Activity, run by Anil Nigam at 1 site in Canada.
Trial summary
The number of persons with hypertension is increasing and with it the number of related cardiovascular events and related functional or cognitive declines. While studies have suggested that physical activity, in particular, high-intensity interval training (HIIT), could be as efficient as the commonly used… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension,Essential, Exercise Activity
- What is being tested?
- 24h-Ambulatory Blood Pressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 26 Apr 2018to 10 Jan 2022
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age at consent ≥ 60 years;
- Systolic Blood pressure measured through BPtru™ between SBP ≥ 120 mmHg and < 140 and or DBP ≥ 80 mmHg
- Being able to sign the informed consent form
Who cannot join
- Considered "highly active" according to the International Physical Activity Questionnaire
- Practicing more than 20 min per week of High-Intensity Interval Training
- Use of antihypertensive medication
- Contraindication for the practice of intense physical activity
- Functional limitations related to the exercise test and to intensive training
- Cardiovascular pathology
Show all 12Show fewer
- Atrial fibrillation
- Psychiatric or neurological disorder
- Renal failure
- MMSE score < 26
- Persons benefiting of enhanced protection: persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection and patients in emergency situations.
- Diabetes
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Cardiovascular Prevention and Rehabilitation Center
Montreal, Quebec, H1T 1N6
Julie Lalonge, 5143741480 ext. 4259, julie.lalonge@icm-mhi.org
Anil Nigam, MD
About this study
Official title: Effect of High-Intensity Interval Training Compared to Hydrochlorothiazide on Ambulatory Blood Pressure, Cardiovascular Health, Cognition and Mobility in Pre-Hypertensive Older Adults.
The number of persons with hypertension is increasing and with it the number of related cardiovascular events and related functional or cognitive declines. While studies have suggested that physical activity, in particular, high-intensity interval training (HIIT), could be as efficient as the commonly used antihypertensive medications, no studies have actually compared their effects in the same population. This protocol will determine if HIIT is at least as efficient as hydrochlorothiazide in order to lower 24h-ambulatory blood pressure (BP) in prehypertensive older adults.
- Conditions
- Hypertension,Essential, Exercise Activity
- Being tested
- 24h-Ambulatory Blood Pressure
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
24h-Ambulatory Blood PressureOther
Also called Cognition, Cardiovascular Health, Mobility
Effect of High Intensity Interval Training compared to Hydrochlorothiazide on ambulatory Blood Pressure.
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Interval Training (HIIT) | Experimental | For the twelve weeks of intervention, participants will have three training sessions per week. Each session will be done on a cycle ergometer and will last approximately 40 minutes. Participants will be supervised by certified kinesiologists and their training programs will be revised every four weeks. Receives: Other: 24h-Ambulatory Blood Pressure |
| HydroChloroThiazide | Active comparator | For this group, participants have to take a diuretic (12,5 mg of Hydrochlorothiazide) daily prescribed by the doctor of this study, for twelve weeks. Participants should also maintain the same lifestyle habits that they had before the study. Receives: Other: 24h-Ambulatory Blood Pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
24h-Ambulatory Blood Pressure
The 24-hour ambulatory measure of the blood pressure (AMBP)
Measured: At baseline and after twelve weeks of intervention
Secondary outcomes (3)
Cardiovascular evaluation
Maximum incremental cardiopulmonary exercise test (VO2MAX)
Measured: Before and after twelve weeks of intervention
Cognitive functions
Cognitive functions will be measured at rest with a pen-paper battery test by a neuropsychologist. The investigators will measure change of score to the cognitive tests.
Measured: Before and after twelve weeks of intervention
Flow Mediated Dilatation (FMD)
Percentage of dilatation of the brachial artery
Measured: Before and after twelve weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start26 Apr 2018
- Primary completion1 Jun 2021 (estimated)
- Study completion10 Jan 2022 (estimated)
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 Hypertension,EssentialStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anil Nigam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anil Nigam, Montreal Heart Institute
- Investigators
- Anil Nigam, MD, Principal investigator, Montreal Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04103411
- Sponsor's protocol ID
- 2018-2319
- Acronym
- DIISCCO
- Status last verified
- Sep 2019
- First submitted
- 18 Sep 2019
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Langeard A, Cloutier SO, Olmand M, Saillant K, Gagnon C, Gregoire CA, Fortier A, Lacroix M, Lalonge J, Gayda M, Besnier F, Gagnon D, Bherer L, Nigam A. High-intensity interval training vs. hydrochlorothiazide on blood pressure, cardiovascular health and cognition: Protocol of a non-inferiority trial. Contemp Clin Trials. 2021 Mar;102:106286. doi: 10.1016/j.cct.2021.106286. Epub 2021 Jan 20.
PubMed 33484896
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High-Intensity Interval Training Compared to Hydrochlorothiazide on Ambulatory Blood Pressure, Cardiovascular Health, Cognition and Mobility in Pre-Hypertensive Older Adults.
- ClinicalTrials.gov ID
- NCT04103411
- Acronym / sponsor ID
- DIISCCO / 2018-2319
- Conditions
- Hypertension,Essential, Exercise Activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Anil NigamUniversity, hospital or other
- Study start
- 26 Apr 2018 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 10 Jan 2022 (estimated)
- First posted
- 25 Sep 2019 (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 number of persons with hypertension is increasing and with it the number of related cardiovascular events and related functional or cognitive declines. While studies have suggested that physical activity, in particular, high-intensity interval training (HIIT), could be as efficient as the commonly used antihypertensive medications, no studies have actually compared their effects in the same population. This protocol will determine if HIIT is at least as efficient as hydrochlorothiazide in order to lower 24h-ambulatory blood pressure (BP) in prehypertensive older adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Intensity Interval Training (HIIT) | Experimental | Other: 24h-Ambulatory Blood PressureFor the twelve weeks of intervention, participants will have three training sessions per week. Each session will be done on a cycle ergometer and will last approximately 40 minutes. Participants will be supervised by certified kinesiologists and their training programs will be revised every four weeks. |
| HydroChloroThiazide | Active comparator | Other: 24h-Ambulatory Blood PressureFor this group, participants have to take a diuretic (12,5 mg of Hydrochlorothiazide) daily prescribed by the doctor of this study, for twelve weeks. Participants should also maintain the same lifestyle habits that they had before the study. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age at consent ≥ 60 years;
- Systolic Blood pressure measured through BPtru™ between SBP ≥ 120 mmHg and < 140 and or DBP ≥ 80 mmHg
- Being able to sign the informed consent form
Key exclusion criteria (12 listed)
- Considered "highly active" according to the International Physical Activity Questionnaire
- Practicing more than 20 min per week of High-Intensity Interval Training
- Use of antihypertensive medication
- Contraindication for the practice of intense physical activity
- Functional limitations related to the exercise test and to intensive training
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 |
|---|---|---|
| 24h-Ambulatory Blood PressureAlso: Cognition, Cardiovascular Health, MobilityEffect of High Intensity Interval Training compared to Hydrochlorothiazide on ambulatory Blood Pressure. | Other | High Intensity Interval Training (HIIT), HydroChloroThiazide |
Primary outcome
24h-Ambulatory Blood Pressure
Time frame: At baseline and after twelve weeks of intervention
The 24-hour ambulatory measure of the blood pressure (AMBP)
3 secondary outcomes
Cardiovascular evaluation
Time frame: Before and after twelve weeks of intervention
Cognitive functions
Time frame: Before and after twelve weeks of intervention
Flow Mediated Dilatation (FMD)
Time frame: Before and after twelve weeks of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Derived from this study: PubMed 33484896Langeard A, Cloutier SO, Olmand M, Saillant K, Gagnon C, Gregoire CA, Fortier A, Lacroix M, Lalonge J, Gayda M, Besnier F, Gagnon D, Bherer L, Nigam A. High-intensity interval training vs. hydrochlorothiazide on blood pressure, cardiovascular health and cognition: Protocol of a non-inferiority trial. Contemp Clin Trials. 2021 Mar;102:106286. doi: 10.1016/j.cct.2021.106286. Epub 2021 Jan 20.
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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.
Anil Nigam, MD principal investigator
Montreal Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 24h-Ambulatory Blood Pressure in people with Hypertension,Essential and Exercise Activity, run by Anil Nigam 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 3 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 25 Sep 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anil Nigam, MD (514-376-3330 ext. 4033, anil.nigam@icm-mhi.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24h-Ambulatory Blood Pressure (time frame: At baseline and after twelve weeks of intervention). 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 NCT04103411, 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 25 Sep 2019.