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

Sponsor
Anil Nigam (Other)
Overall Status
Unknown status
CT.gov ID
NCT04103411
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
44.5
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: 24h-Ambulatory Blood Pressure
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
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.
Actual Study Start Date :
Apr 26, 2018
Anticipated Primary Completion Date :
Jun 1, 2021
Anticipated Study Completion Date :
Jan 10, 2022

Arms and Interventions

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
  • Cardiovascular Health
  • Mobility

    		•
    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
  • Cardiovascular Health
  • Mobility

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 24h-Ambulatory Blood Pressure [At baseline and after twelve weeks of intervention]

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

    Secondary Outcome Measures

    1. Cardiovascular evaluation [Before and after twelve weeks of intervention]

      Maximum incremental cardiopulmonary exercise test (VO2MAX)

    2. Cognitive functions [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.

    3. Flow Mediated Dilatation (FMD) [Before and after twelve weeks of intervention]

      Percentage of dilatation of the brachial artery

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cardiovascular Prevention and Rehabilitation Center Montreal Quebec Canada H1T 1N6

    Sponsors and Collaborators

    • Anil Nigam

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Anil Nigam, MD, cardiologist, Montreal Heart Institute
    ClinicalTrials.gov Identifier:
    NCT04103411
    Other Study ID Numbers:
    • 2018-2319
    First Posted:
    Sep 25, 2019
    Last Update Posted:
    Sep 25, 2019
    Last Verified:
    Sep 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Essential Hypertension

    Study Results

    No Results Posted as of Sep 25, 2019