- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07453550
The Effects of Brief Periods of Exercise on Blood Pressure
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jinghui Yang, PT, MPT, PhD
- Phone Number: 347-429-0843
- Email: jiyang@hartford.edu
Study Locations
-
-
Connecticut
-
West Hartford, Connecticut, United States, 06117
- Recruiting
- University of Hartford
-
Contact:
- Jinghui Yang
- Phone Number: 3474290843
- Email: jiyang@hartford.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18-55 yrs.
- 24 hour average BP >110/70 mmHg, but < 160 systolic blood pressure
- Able to provide informed consent
Exclusion Criteria:
- Currently taking anti-hypertensive medication smokers and alcohol drinkers Inability to undertake exercise intervention (resistance and isometric exercise)
Current medical history of any of the following:
hyperaldosteronism Diabetes mellitus (Type 1 or type 2) Heart disease Stroke or transient ischemic attack Peripheral neuropathy Aortic aneurysm and/or peripheral arterial disease If female, pregnancy or currently breast feeding Enrolled in another Clinical Trial of an Interventional Medicinal Product or Medical Device or other interventional study Medical condition that, in the opinion of the investigator, would make the participant unsuitable for the study On long term warfarin Allergies to blood pressure cuff materials or ultrasound gel
Previous medication history of any of the following:
hyperaldosteronism Heart disease Stroke or transient ischemic attack Peripheral neuropathy Aortic aneurysm and/or peripheral arterial disease thromboembolism Infection within limb within 3 months On long term warfarin Allergies to blood pressure cuff materials or ultrasound gel
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Non-Ex control group
|
|
|
Active Comparator: Clustered Ex Condition
|
The other exercise group will do 4 sets of wall squat in a continuous way.
|
|
Experimental: Scattered Ex Condition
|
the experimental group will complete the four sets of wall-squats at four different times across the day: morning, noon, afternoon, night.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
24 h blood pressure
Time Frame: From the enrollment to the end of the study at six weeks
|
The average, peak and variations of 24 h SBP and DBP, daytime SBP and DBP, night time SBP and DBP will be measured before and after the intervention.
|
From the enrollment to the end of the study at six weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
endothelial function
Time Frame: at baseline (Day 1) and Week 6
|
endothelial function measured by flow mediated dilation
|
at baseline (Day 1) and Week 6
|
|
arterial stiffness
Time Frame: at baseline (Day 1) and week 6
|
arterial stiffness measured by pulse wave velocity
|
at baseline (Day 1) and week 6
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25-12-505
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
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.
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