- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03947996
Stretching Versus Walking From Reducing Blood Pressure
Comparison of Stretching and Walking as Exercise Modalities for Reducing Blood Pressure
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Saskatchewan
-
Saskatoon, Saskatchewan, Canada, S7N5B2
- College of Kinesiology, University of Saskatchewan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Stretching
|
Stretching (30 minutes, 5 days per week, 8 weeks)
|
|
Experimental: Walking
|
Walking (30 minutes, 5 days per week, 8 weeks)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Night time blood pressure
Time Frame: Change from Baseline Night Time Blood Pressure at 8 weeks
|
Blood pressure assessed during the night with an automated device
|
Change from Baseline Night Time Blood Pressure at 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Day time blood pressure
Time Frame: Change from Baseline Day Time Blood Pressure at 8 weeks
|
Blood pressure assessed during the day with an automated device
|
Change from Baseline Day Time Blood Pressure at 8 weeks
|
|
Sitting blood pressure
Time Frame: Change from Baseline Sitting Blood Pressure at 8 weeks
|
Blood pressure assessed while sitting
|
Change from Baseline Sitting Blood Pressure at 8 weeks
|
|
Lying blood pressure
Time Frame: Change from Baseline Lying Blood Pressure at 8 weeks
|
Blood pressure assessed while lying down
|
Change from Baseline Lying Blood Pressure at 8 weeks
|
|
Walking test
Time Frame: Change from Baseline Walking Distance at 8 weeks
|
Maximal distance walked in six minutes
|
Change from Baseline Walking Distance at 8 weeks
|
|
Waist circumference
Time Frame: Change from Baseline Waist Circumference at 8 weeks
|
Waist circumference measured with a measuring tape
|
Change from Baseline Waist Circumference at 8 weeks
|
|
Body mass
Time Frame: Change from Baseline Body Mass at 8 weeks
|
Body mass measured with a scale
|
Change from Baseline Body Mass at 8 weeks
|
|
Resting heart rate
Time Frame: Change from Baseline Resting Heart Rate at 8 weeks
|
Heart rate at rest measured with a heart rate monitor
|
Change from Baseline Resting Heart Rate at 8 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1133
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Hypertension
-
National Taiwan University Hospital Hsin-Chu BranchRecruitingHypertension,Essential | Hypertension, MaskedTaiwan
-
BackBeat Medical IncNot yet recruitingHypertension, Systolic | Hypertension (HTN) | Heart Failure With Preserved Ejection Fraction (HFpEFGeorgia
-
Xuanwu Hospital, BeijingNot yet recruiting
-
Shenzhen Salubris Pharmaceuticals Co., Ltd.Not yet recruiting
-
Instituto de Cardiologia do Rio Grande do SulCompletedHypertension (HTN) | Hypertension ArterialBrazil
-
University of Alabama at BirminghamTroy UniversityCompletedHypertension | Hypertension, Resistant to Conventional Therapy | Uncontrolled Hypertension | Hypertension, White CoatUnited States
-
Franz Rischard, DOAcceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway...Not yet recruitingPulmonary Hypertension | Pulmonary Arterial Hypertension (PAH)United States
-
Abant Izzet Baysal UniversityNot yet recruitingPRIMARY HYPERTENSIONTurkey (Türkiye)
-
SingHealth PolyclinicsNanyang PolytechnicEnrolling by invitationHypertension,EssentialSingapore
-
Hacettepe UniversityBozok UniversityCompletedHypertension | Arterial Hypertension | Systemic HypertensionTurkey (Türkiye)
Clinical Trials on Stretching exercise
-
Tokat Gaziosmanpasa UniversityCompleted
-
Dragan MijatovićCompletedStretchBosnia and Herzegovina
-
Eastern Mediterranean UniversityRecruiting
-
Istanbul University - Cerrahpasa (IUC)CompletedEffects of PNF and Static Stretching on Architecture and Viscoelastic Properties of Hemiplegic ElbowStroke | Spasticity, MuscleTurkey
-
European Institute of OncologyFondazione Umberto VeronesiCompleted
-
Riphah International UniversityCompletedMusculoskeletal PainPakistan
-
Wake Forest UniversityAmerican Diabetes AssociationCompletedMild Cognitive Impairment | PrediabetesUnited States
-
University of Illinois at Urbana-ChampaignCompletedMultiple SclerosisUnited States
-
University of SaskatchewanCanadian Institutes of Health Research (CIHR)Recruiting
-
Children's Hospital of PhiladelphiaBoston Children's Hospital; University at BuffaloCompletedBrain Concussion | Mild Traumatic Brain Injury | Acute Brain InjuryUnited States