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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04103411
Other study ID # 2018-2319
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 26, 2018
Est. completion date January 10, 2022

Study information

Verified date September 2019
Source Montreal Heart Institute
Contact Anil Nigam, MD
Phone 514-376-3330
Email anil.nigam@icm-mhi.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date January 10, 2022
Est. primary completion date June 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years and older
Eligibility 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 Design


Intervention

Other:
24h-Ambulatory Blood Pressure
Effect of High Intensity Interval Training compared to Hydrochlorothiazide on ambulatory Blood Pressure.

Locations

Country Name City State
Canada Cardiovascular Prevention and Rehabilitation Center Montreal Quebec

Sponsors (1)

Lead Sponsor Collaborator
Anil Nigam

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 24h-Ambulatory Blood Pressure The 24-hour ambulatory measure of the blood pressure (AMBP) At baseline and after twelve weeks of intervention
Secondary Cardiovascular evaluation Maximum incremental cardiopulmonary exercise test (VO2MAX) Before and after twelve weeks of intervention
Secondary 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. Before and after twelve weeks of intervention
Secondary Flow Mediated Dilatation (FMD) Percentage of dilatation of the brachial artery Before and after twelve weeks of intervention
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