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

NCT ID: NCT04103411

Last Updated: 2019-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-26

Study Completion Date

2022-01-10

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension,Essential Exercise Activity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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High Intensity Interval Training (HIIT)

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.

Group Type EXPERIMENTAL

24h-Ambulatory Blood Pressure

Intervention Type OTHER

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

HydroChloroThiazide

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.

Group Type ACTIVE_COMPARATOR

24h-Ambulatory Blood Pressure

Intervention Type OTHER

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

Interventions

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24h-Ambulatory Blood Pressure

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

Intervention Type OTHER

Other Intervention Names

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Cognition Cardiovascular Health Mobility

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Anil Nigam

OTHER

Sponsor Role lead

Responsible Party

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Anil Nigam

MD, cardiologist

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Anil Nigam, MD

Role: PRINCIPAL_INVESTIGATOR

Montreal Heart Institute

Locations

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Cardiovascular Prevention and Rehabilitation Center

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Anil Nigam, MD

Role: CONTACT

514-376-3330 ext. 4033

Antoine Langeard, PhD

Role: CONTACT

514-374-1480 ext. 4369

Facility Contacts

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Julie Lalonge

Role: primary

5143741480 ext. 4259

References

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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.

Reference Type DERIVED
PMID: 33484896 (View on PubMed)

Other Identifiers

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2018-2319

Identifier Type: -

Identifier Source: org_study_id

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