Effect of High-Intensity Interval Training Compared to Hydrochlorothiazide on Ambulatory Blood Pressure

NCT04103411 | Unknown

• 1 other identifier: 2018-2319
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension,Essential; Exercise Activity

Outcome Measures

Primary Outcomes (1)

• 24h-Ambulatory Blood Pressure

  The 24-hour ambulatory measure of the blood pressure (AMBP)

  At baseline and after twelve weeks of intervention

Secondary Outcomes (3)

• Cardiovascular evaluation

  Before and after twelve weeks of intervention

• Cognitive functions

  Before and after twelve weeks of intervention

• Flow Mediated Dilatation (FMD)

  Before and after twelve weeks of intervention

Study Arms (2)

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.

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.

Other: 24h-Ambulatory Blood Pressure

Interventions

24h-Ambulatory Blood Pressure OTHER

Effect of High Intensity Interval Training compared to Hydrochlorothiazide on ambulatory Blood Pressure.

Also known as: Cognition, Cardiovascular Health, Mobility

High Intensity Interval Training (HIIT); HydroChloroThiazide

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Anil Nigam: lead

Study Sites (1)

Cardiovascular Prevention and Rehabilitation Center

Montreal, Quebec, H1T 1N6, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 33484896 DERIVED

MeSH Terms

Conditions

Essential Hypertension

Interventions

Range of Motion, Articular

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Anil Nigam, MD

  Montreal Heart Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anil Nigam, MD

CONTACT

514-376-3330; anil.nigam@icm-mhi.org

Antoine Langeard, PhD

CONTACT

514-374-1480; langeard.antoine@hotmail.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, cardiologist

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: September 25, 2019
• Study Start: April 26, 2018
• Primary Completion: June 1, 2021
• Study Completion: January 10, 2022
• Last Updated: September 25, 2019

Record last verified: 2019-09

Locations

CA (1)