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Stretching vs Walking for Lowering Blood Pressure

Primary Purpose

Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Stretching exercise
Walking exercise
Sponsored by
University of Saskatchewan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

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

Inclusion Criteria:

  • Systolic blood pressure between 130 and 159 mmHg OR diastolic blood pressure between 85 and 99 mmHg
  • Able to walk unaided for 30 minutes
  • Can safely perform exercises as determined by the Get Active Questionnaire

Exclusion Criteria:

  • Not on blood pressure medication unless it has been a stable dose for 6 months and target blood pressure has not been achieved (i.e. below 140/90 mmHg)
  • Smoking
  • Already performing 150 minutes or more moderate to vigorous physical activity per week
  • Already involved in a flexibility-training program (e.g. Yoga or Pilates)
  • Pregnant or lactating or planning to become pregnant during the study

Sites / Locations

  • University of SaskatchewanRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Stretching

Walking

Arm Description

Stretching

Walking

Outcomes

Primary Outcome Measures

Night time systolic and diastolic blood pressure
Blood pressure assessed during the night with an automated device

Secondary Outcome Measures

Day time systolic and diastolic blood pressure
Blood pressure assessed during the day with an automated device
Sitting systolic and diastolic blood pressure
Blood pressure assessed while sitting
Lying systolic and diastolic blood pressure
Blood pressure assessed while lying supine
Arterial stiffness
Arterial stiffness assessed with aplanation tonometry
Heart rate variability
Heart rate variability assessed with electrocardiography
Hamstrings flexibility
Hamstrings flexibility assessed with a sit-and-reach test
Shoulder flexibility
Shoulder flexibility assessed with a goniometer
Peak oxygen consumption
Peak oxygen consumption assessed with a metabolic cart during a progressive-intensity treadmill test

Full Information

First Posted
February 12, 2022
Last Updated
June 2, 2023
Sponsor
University of Saskatchewan
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT05252208
Brief Title
Stretching vs Walking for Lowering Blood Pressure
Official Title
Is Stretching Superior to Aerobic Training for Reducing Blood Pressure?
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 28, 2022 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
August 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Saskatchewan
Collaborators
Canadian Institutes of Health Research (CIHR)

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
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). Stretching may also be effective because it may cause changes in blood vessel stiffness and therefore reduce resistance to blood flow. The study will assess a group of individuals (i.e. 96) participating in a supervised stretching or walking program five days per week for six months to determine 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.
Detailed Description
Hypertension or high blood pressure is a prevalent and leading risk factor for heart disease and stroke afflicting seven million people in Canada and costing our health system approximately $20 billion annually. The prevailing exercise recommendation for people with hypertension is to perform aerobic training (i.e. brisk walking) as a non-pharmacological way to moderately reduce blood pressure. Evidence from several recent studies indicates flexibility training may accrue more positive changes in blood pressure than aerobic training. Additional recent studies show stretching can reduce arterial stiffness and sympathetic nervous system activation, suggesting physiological mechanisms by which blood pressure might be reduced through exercises designed mostly to improve flexibility. The purpose of this study is to determine if a 6-month flexibility program is superior to aerobic training for reducing 24-hour blood pressure measurements, improving measures of vascular function (i.e. arterial stiffness), and improving the ratio of parasympathetic to sympathetic nervous system activation. This study involves a randomized controlled trial of 96 men and women presenting with either high-normal blood pressure (systolic 130 to 139 mmHg or diastolic 85 to 89 mmHg) or stage 1 hypertension (systolic 140 to 159 mmHg or diastolic 90 to 99 mmHg) stratified by blood pressure (i.e. either high normal or stage 1 hypertension), sex, and age (≥55y or <55y) and randomized to one of two groups for six months duration: 1) a flexibility program (30 minutes of stretching per day); or 2) an aerobic training program (30 minutes of brisk walking per day). Assessments pre- and post-intervention and three months later include: 24-hour ambulatory blood pressure, arterial stiffness, and heart rate variability. .

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel groups: Two groups: Walking exercise and stretching exercise
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stretching
Arm Type
Experimental
Arm Description
Stretching
Arm Title
Walking
Arm Type
Experimental
Arm Description
Walking
Intervention Type
Other
Intervention Name(s)
Stretching exercise
Intervention Description
Stretching (30-45 minutes, 5 days per week, 6 months)
Intervention Type
Other
Intervention Name(s)
Walking exercise
Intervention Description
Walking (30-45 minutes, 5 days per week, 6 months)
Primary Outcome Measure Information:
Title
Night time systolic and diastolic blood pressure
Description
Blood pressure assessed during the night with an automated device
Time Frame
Change from baseline night time blood pressure at 6 months
Secondary Outcome Measure Information:
Title
Day time systolic and diastolic blood pressure
Description
Blood pressure assessed during the day with an automated device
Time Frame
Change from baseline day time blood pressure at 6 months
Title
Sitting systolic and diastolic blood pressure
Description
Blood pressure assessed while sitting
Time Frame
Change from baseline sitting blood pressure at 6 months
Title
Lying systolic and diastolic blood pressure
Description
Blood pressure assessed while lying supine
Time Frame
Change from baseline lying blood pressure at 6 months
Title
Arterial stiffness
Description
Arterial stiffness assessed with aplanation tonometry
Time Frame
Change from baseline arterial stiffness at 6 months
Title
Heart rate variability
Description
Heart rate variability assessed with electrocardiography
Time Frame
Change from baseline heart rate variability at 6 months
Title
Hamstrings flexibility
Description
Hamstrings flexibility assessed with a sit-and-reach test
Time Frame
Change from baseline hamstrings flexibiliity at 6 months
Title
Shoulder flexibility
Description
Shoulder flexibility assessed with a goniometer
Time Frame
Change from baseline shoulder flexibility at 6 months
Title
Peak oxygen consumption
Description
Peak oxygen consumption assessed with a metabolic cart during a progressive-intensity treadmill test
Time Frame
Change from baseline peak oxygen consumption at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Systolic blood pressure between 130 and 159 mmHg OR diastolic blood pressure between 85 and 99 mmHg Able to walk unaided for 30 minutes Can safely perform exercises as determined by the Get Active Questionnaire Exclusion Criteria: Not on blood pressure medication unless it has been a stable dose for 6 months and target blood pressure has not been achieved (i.e. below 140/90 mmHg) Smoking Already performing 150 minutes or more moderate to vigorous physical activity per week Already involved in a flexibility-training program (e.g. Yoga or Pilates) Pregnant or lactating or planning to become pregnant during the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philip Chilibeck, Ph.D.
Phone
306-966-1072
Email
phil.chilibeck@usask.ca
First Name & Middle Initial & Last Name or Official Title & Degree
John Ko, M.Sc.
Phone
306-966-1082
Email
jongbum.ko@usask.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Chilibeck, Ph.D.
Organizational Affiliation
University of Saskatchewan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Saskatchewan
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N5B2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Ko, M.Sc.
Phone
306-966-1186
Email
jongbum.ko@usask.ca

12. IPD Sharing Statement

Plan to Share IPD
No

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Stretching vs Walking for Lowering Blood Pressure

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