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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03947996
Other study ID # 1133
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 15, 2019
Est. completion date December 31, 2019

Study information

Verified date February 2021
Source University of Saskatchewan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

High blood pressure is a leading risk factor for cardiovascular disease. Traditionally, one of the ways to treat or prevent high blood pressure is to prescribe aerobic exercise training (i.e.brisk walking). Previous studies have shown that stretching is also very effective for reducing blood pressure. This is an exciting possibility because if stretching is more effective, it would change the way exercise is prescribed to people with elevated blood pressure. This study will now assess 20 individuals in a supervised stretching or walking program five days per week for 8 weeks to determine for certain whether stretching is superior for reducing blood pressure. This research will contribute to recommendations about the most effective exercise programs for reducing blood pressure and risk of cardiovascular disease.


Description:

The study hypothesis is that stretching (flexibility training) will be superior to brisk walking for reducing blood pressure. This is a parallel-group randomised trial. Twenty participants (aged 18 and older) with borderline or stage-1 hypertension (systolic blood pressure between 130 and 159 mmHg OR diastolic blood pressure between 85 and 99 mmHg) will be randomised to walking or stretching groups. Each group will do 30 minutes of exercise, five days per week. Exercise sessions will be supervised three days per week with participants doing exercise sessions on their own two days per week. Exercise sessions involve either brisk walking or stretching. The stretching exercises will involve stretching all major muscle groups. The main outcome is 24-hour blood pressure which will be assessed at baseline, after four weeks, and after eight weeks. Other outcomes will be assessed at baseline and eight weeks and include: Body weight, height, waist circumference, resting heart rate, physical activity levels (questionnaire), diet (questionnaire), maximal distance walked in six minutes. All participants will be counselled on how to follow the DASH eating plan, which involves reducing dietary salt intake. Statistical analyses: All outcomes will be assessed with a group x time ANOVA with alpha level of 0.05. LSD post-hoc tests will be done when necessary to identify differences between pairs of means.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date December 31, 2019
Est. primary completion date September 15, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Systolic blood pressure between 130 and 159 mmHg OR diastolic blood pressure between 85 and 99 mmHg Exclusion Criteria: - Individuals will be excluded if they have taken blood pressure medications within the past six months unless they are on a stable dose of medication and have not reach target blood pressure levels (i.e. systolic blood pressure below 130 mmHg and diastolic blood pressure below 85 mmHg)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Stretching exercise
Stretching (30 minutes, 5 days per week, 8 weeks)
Walking exercise
Walking (30 minutes, 5 days per week, 8 weeks)

Locations

Country Name City State
Canada College of Kinesiology, University of Saskatchewan Saskatoon Saskatchewan

Sponsors (2)

Lead Sponsor Collaborator
University of Saskatchewan Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Ko J, Deprez D, Shaw K, Alcorn J, Hadjistavropoulos T, Tomczak C, Foulds H, Chilibeck PD. Stretching is Superior to Brisk Walking for Reducing Blood Pressure in People With High-Normal Blood Pressure or Stage I Hypertension. J Phys Act Health. 2020 Dec 18:1-8. doi: 10.1123/jpah.2020-0365. [Epub ahead of print] — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Night time blood pressure Blood pressure assessed during the night with an automated device Change from Baseline Night Time Blood Pressure at 8 weeks
Secondary Day time blood pressure Blood pressure assessed during the day with an automated device Change from Baseline Day Time Blood Pressure at 8 weeks
Secondary Sitting blood pressure Blood pressure assessed while sitting Change from Baseline Sitting Blood Pressure at 8 weeks
Secondary Lying blood pressure Blood pressure assessed while lying down Change from Baseline Lying Blood Pressure at 8 weeks
Secondary Walking test Maximal distance walked in six minutes Change from Baseline Walking Distance at 8 weeks
Secondary Waist circumference Waist circumference measured with a measuring tape Change from Baseline Waist Circumference at 8 weeks
Secondary Body mass Body mass measured with a scale Change from Baseline Body Mass at 8 weeks
Secondary Resting heart rate Heart rate at rest measured with a heart rate monitor Change from Baseline Resting Heart Rate at 8 weeks
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