Clinical trial NCT04103411: Effect of High-Intensity Interval Training Compared to Hydrochlorothiazide on Ambulatory Blood Pressure
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension,Essential
Exercise Activity
Lead sponsor: Montreal Heart Institute
Sponsor class: OTHER
First posted: 2019-09-25
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

1. Age at consent ≥ 60 years;
2. Systolic Blood pressure measured through BPtru™ between SBP ≥ 120 mmHg and \< 140 and or DBP ≥ 80 mmHg
3. Being able to sign the informed consent form

Exclusion Criteria:

1. Considered "highly active" according to the International Physical Activity Questionnaire
2. Practicing more than 20 min per week of High-Intensity Interval Training
3. Use of antihypertensive medication
4. Contraindication for the practice of intense physical activity
5. Functional limitations related to the exercise test and to intensive training
6. Cardiovascular pathology
7. Atrial fibrillation
8. Psychiatric or neurological disorder
9. Renal failure
10. MMSE score \< 26
11. 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.
12. Diabetes

Primary outcomes:
measure: 24h-Ambulatory Blood Pressure
timeFrame: At baseline and after twelve weeks of intervention
Secondary outcomes:
measure: Cardiovascular evaluation
timeFrame: Before and after twelve weeks of intervention
measure: Cognitive functions
timeFrame: Before and after twelve weeks of intervention
measure: Flow Mediated Dilatation (FMD)
timeFrame: Before and after twelve weeks of intervention
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Cardiovascular Prevention and Rehabilitation Center
state: Quebec
Study officials:
affiliation: Montreal Heart Institute
name: Anil Nigam, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.