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

September 23, 2019 updated by: Anil Nigam

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H1T 1N6
        • Recruiting
        • Cardiovascular Prevention and Rehabilitation Center
        • Contact:
        • Principal Investigator:
          • Anil Nigam, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 24h-Ambulatory Blood Pressure
Effect of High Intensity Interval Training compared to Hydrochlorothiazide on ambulatory Blood Pressure.
Other Names:
  • Cognition
  • Mobility
  • Cardiovascular Health
Active Comparator: 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.
Other: 24h-Ambulatory Blood Pressure
Effect of High Intensity Interval Training compared to Hydrochlorothiazide on ambulatory Blood Pressure.
Other Names:
  • Cognition
  • Mobility
  • Cardiovascular Health

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24h-Ambulatory Blood Pressure
Time Frame: At baseline and after twelve weeks of intervention
The 24-hour ambulatory measure of the blood pressure (AMBP)
At baseline and after twelve weeks of intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular evaluation
Time Frame: Before and after twelve weeks of intervention
Maximum incremental cardiopulmonary exercise test (VO2MAX)
Before and after twelve weeks of intervention
Cognitive functions
Time Frame: Before and after twelve weeks of intervention
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.
Before and after twelve weeks of intervention
Flow Mediated Dilatation (FMD)
Time Frame: Before and after twelve weeks of intervention
Percentage of dilatation of the brachial artery
Before and after twelve weeks of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anil Nigam

Investigators

  • Principal Investigator: Anil Nigam, MD, Montreal Heart Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 26, 2018

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

January 10, 2022

Study Registration Dates

First Submitted

September 18, 2019

First Submitted That Met QC Criteria

September 23, 2019

First Posted (Actual)

September 25, 2019

Study Record Updates

Last Update Posted (Actual)

September 25, 2019

Last Update Submitted That Met QC Criteria

September 23, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-2319

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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