- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04546308
Central Arterial Hemodynamics and Resistance Training
December 21, 2022 updated by: National Taiwan University Hospital
Central Blood Pressure and Arterial Hemodynamic Responses to High-intensity Resistance Exercise Training - the Application of Ultrafast Ultrasound Analysis
Resistance exercise training is one of the popular exercise modes that has been drawn the public's attention.
However, existing evidence showed high-intensity resistance exercise training-induced negative adaptation on vascular function and blood pressure responses.
Upper-body resistance exercise training is more likely to induced arterial stiffening, which has been shown to be gender-dependent.
It is still unknown whether age also plays a role.
We like to test the hypothesis that high-intensity upper body resistance exercise may lead to a higher increase of arterial stiffness, central blood pressure, and hemodynamic parameters in younger adults than older adults.
We also hypothesize high intensity resistance training could contribute to greater central hemodynamic responses and muscle stiffness than the control; the change of muscle stiffness correlates with the change of hemodynamic parameters.
Collectively, study 1 in this project is aimed to recruit 40 apparently healthy young (20-35yrs) and middle-aged to older adults (50-75yrs) into this study followed by upper-body or lower-body high-intensity exercise (80% 1 repetition maximum, 10 reps, 4 sets) by a randomized order.
Blood draw, central blood pressure, hemodynamics will be performed and obtained at pre-, immediately-post, 20min, 40mins, and 60 mins post-exercise.
Study 2 is aimed to investigate the effects of 8-week whole-body resistance exercise training followed by a 4-week detraining on above-measured variables in order to determine the long-term effects on resistance training.
We will employee state-of-art ultrafast ultrasound to obtain muscle stiffness and carotid local pulse wave velocity.
Endothelin-1 and catecholamines will also be measured to discover its underlying mechanisms on such stiffening effects induced by high-intensity resistance exercise.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hsin-Fu Lin, Ph.D
- Phone Number: 585 02-33665959
- Email: hsinfu@ntu.edu.tw
Study Locations
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-
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Taipei, Taiwan, 106
- National Taiwan University
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Contact:
- Hsin-Fu Lin, Ph.D
- Email: hsinfu@ntu.edu.tw
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy middle-aged to older adults
Exclusion Criteria:
- (1)BMI≧27, (2) Smoking habits for more than six months in the past, (3) Hypertension (blood pressure>140/90 mmHg), (4) Personal diabetes history (fasting blood sugar >126 mg /dL), heart disease, or other cardiovascular diseases, (5) bone damage, (6) regular use of supplements or vitamins
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exercise training
The participants will undergo 8 weeks of whole-body resistance exercise training followed by a 4-week detraining.
The central hemodynamic and muscle stiffness variables will be measured pre, post-training, and post-detraining.
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Eight weeks whole-body resistance exercise training (80%1 repetition maximal, 3 sessions per week) followed by a 4-week detraining intervention
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No Intervention: Sedentary control
The participants will undergo 12 weeks of intervention without exercise training.
The central hemodynamic and muscle stiffness variables will be measured pre, 8th, and 12th week.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Central blood pressure
Time Frame: Pre, 8th and 12th week
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Carotid blood pressure obtained by using tonometer
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Pre, 8th and 12th week
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Muscle shear wave velocity
Time Frame: Pre, 8th and 12th week
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Shear wave velocity measured by using ultrafast ultrasound
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Pre, 8th and 12th week
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Arterial pulse wave velocity
Time Frame: Pre, 8th and 12th week
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Pulse wave velocity measured by using a commercialized vascular monitor.
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Pre, 8th and 12th week
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vascular related biomarkers
Time Frame: Pre, 8th and 12th week
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Catecholamines, endothelin-1
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Pre, 8th and 12th week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 21, 2019
Primary Completion (Actual)
July 31, 2022
Study Completion (Actual)
July 31, 2022
Study Registration Dates
First Submitted
September 6, 2020
First Submitted That Met QC Criteria
September 6, 2020
First Posted (Actual)
September 14, 2020
Study Record Updates
Last Update Posted (Actual)
December 23, 2022
Last Update Submitted That Met QC Criteria
December 21, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201903034RIND
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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