HypertensionNCT04546308
Central Arterial Hemodynamics and Resistance Training
A study testing Resistance exercise training in people with Hypertension and Cardiovascular Risk Factor, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Cardiovascular Risk Factor
- What is being tested?
- Resistance exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 Dec 2019to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy middle-aged to older adults
Who cannot join
- (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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Hypertension, Cardiovascular Risk Factor
- Being tested
- Resistance exercise training
- Keywords
- Exercise, Ultrafast ultrasound
- Medical subject headings
- Hypertension, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance exercise trainingOther
Eight weeks whole-body resistance exercise training (80%1 repetition maximal, 3 sessions per week) followed by a 4-week detraining intervention
| Study group | Role | What they receive |
|---|---|---|
| Exercise training | Experimental | 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. Receives: Other: Resistance exercise training |
| Sedentary control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Central blood pressure
Carotid blood pressure obtained by using tonometer
Measured: Pre, 8th and 12th week
Muscle shear wave velocity
Shear wave velocity measured by using ultrafast ultrasound
Measured: Pre, 8th and 12th week
Arterial pulse wave velocity
Pulse wave velocity measured by using a commercialized vascular monitor.
Measured: Pre, 8th and 12th week
Secondary outcomes (1)
Vascular related biomarkers
Catecholamines, endothelin-1
Measured: Pre, 8th and 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start21 Dec 2019
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04546308
- Sponsor's protocol ID
- 201903034RIND
- Status last verified
- Feb 2022
- First submitted
- 6 Sep 2020
- Last updated
- 23 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Blood Pressure and Arterial Hemodynamic Responses to High-intensity Resistance Exercise Training - the Application of Ultrafast Ultrasound Analysis
- ClinicalTrials.gov ID
- NCT04546308
- Acronym / sponsor ID
- 201903034RIND
- Conditions
- Hypertension, Cardiovascular Risk Factor
- Keywords
- Exercise, Ultrafast ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 21 Dec 2019 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 14 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise training | Experimental | Other: Resistance exercise trainingThe 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. |
| Sedentary control | No intervention | –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. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy middle-aged to older adults
Key exclusion criteria (1 listed)
- (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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance exercise trainingEight weeks whole-body resistance exercise training (80%1 repetition maximal, 3 sessions per week) followed by a 4-week detraining intervention | Other | Exercise training |
Primary outcome
Central blood pressure
Time frame: Pre, 8th and 12th week
Carotid blood pressure obtained by using tonometer
Muscle shear wave velocity
Time frame: Pre, 8th and 12th week
Shear wave velocity measured by using ultrafast ultrasound
Arterial pulse wave velocity
Time frame: Pre, 8th and 12th week
Pulse wave velocity measured by using a commercialized vascular monitor.
1 secondary outcome
Vascular related biomarkers
Time frame: Pre, 8th and 12th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance exercise training in people with Hypertension and Cardiovascular Risk Factor, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central blood pressure (time frame: Pre, 8th and 12th week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2022.