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

Primary Purpose

Hypertension,Essential, Exercise Activity

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
24h-Ambulatory Blood Pressure
Sponsored by
Anil Nigam
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertension,Essential

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Cardiovascular Prevention and Rehabilitation CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High Intensity Interval Training (HIIT)

HydroChloroThiazide

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

24h-Ambulatory Blood Pressure
The 24-hour ambulatory measure of the blood pressure (AMBP)

Secondary Outcome Measures

Cardiovascular evaluation
Maximum incremental cardiopulmonary exercise test (VO2MAX)
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.
Flow Mediated Dilatation (FMD)
Percentage of dilatation of the brachial artery

Full Information

First Posted
September 18, 2019
Last Updated
September 23, 2019
Sponsor
Anil Nigam
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1. Study Identification

Unique Protocol Identification Number
NCT04103411
Brief Title
Effect of High-Intensity Interval Training Compared to Hydrochlorothiazide on Ambulatory Blood Pressure
Acronym
DIISCCO
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

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 26, 2018 (Actual)
Primary Completion Date
June 1, 2021 (Anticipated)
Study Completion Date
January 10, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Anil Nigam

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension,Essential, Exercise Activity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High Intensity Interval Training (HIIT)
Arm Type
Experimental
Arm Description
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.
Arm Title
HydroChloroThiazide
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
24h-Ambulatory Blood Pressure
Other Intervention Name(s)
Cognition, Cardiovascular Health, Mobility
Intervention Description
Effect of High Intensity Interval Training compared to Hydrochlorothiazide on ambulatory Blood Pressure.
Primary Outcome Measure Information:
Title
24h-Ambulatory Blood Pressure
Description
The 24-hour ambulatory measure of the blood pressure (AMBP)
Time Frame
At baseline and after twelve weeks of intervention
Secondary Outcome Measure Information:
Title
Cardiovascular evaluation
Description
Maximum incremental cardiopulmonary exercise test (VO2MAX)
Time Frame
Before and after twelve weeks of intervention
Title
Cognitive functions
Description
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.
Time Frame
Before and after twelve weeks of intervention
Title
Flow Mediated Dilatation (FMD)
Description
Percentage of dilatation of the brachial artery
Time Frame
Before and after twelve weeks of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anil Nigam, MD
Phone
514-376-3330
Ext
4033
Email
anil.nigam@icm-mhi.org
First Name & Middle Initial & Last Name or Official Title & Degree
Antoine Langeard, PhD
Phone
514-374-1480
Ext
4369
Email
langeard.antoine@hotmail.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anil Nigam, MD
Organizational Affiliation
Montreal Heart Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiovascular Prevention and Rehabilitation Center
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1N6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Lalonge
Phone
5143741480
Ext
4259
Email
julie.lalonge@icm-mhi.org
First Name & Middle Initial & Last Name & Degree
Anil Nigam, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
33484896
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.
Results Reference
derived

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

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