Coronary Artery DiseaseNCT03847012
Blood Pressure Responses to Different Exercise Modes in Coronary Artery Disease
A study testing exercise in people with Coronary Artery Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purposes of this study were to compare blood pressure responses of the same target heart rate on different exercise modes in patients with coronary artery diseases (CAD) and to compare the effects of blood pressure responses after exercise training. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Mar 2019to 30 Sep 2020
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with coronary artery diseases who are referred to phase II cardiopulmonary rehabilitation exercise training.
Who cannot join
- patients with non-coronary artery diseases
- atrial fibrillation
- neurological or musculoskeletal problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Blood Pressure Responses to Different Exercise Models in Patients With Coronary Artery Disease
The purposes of this study were to compare blood pressure responses of the same target heart rate on different exercise modes in patients with coronary artery diseases (CAD) and to compare the effects of blood pressure responses after exercise training.
The investigators will recruit 30 subjects with CAD who are referred to phase II cardiopulmonary rehabilitation exercise training. The subjects performed the treadmill or stationary bicycle exercise randomly.
Read the detailed description
Considering cardiopulmonary rehabilitation intensity is often setting by heart rate clinically, and only few study focused on exercise responses patients with CAD, the purposes of this study were to compare blood pressure responses of the same target heart rate on different exercise modes in patients with CAD and to compare the effects of blood pressure responses after exercise training.
This is a crossover trial study. The investigators will recruit 30 subjects with CAD who are referred to phase II cardiopulmonary rehabilitation exercise training. After at least 3 times of familiar with the cardiopulmonary rehabilitation training machine, the subjects performed the treadmill or stationary bicycle and exercise to personalized target heart rate for 10 minutes, take a rest until the heart rate recover to the resting heart rate, and then repeated the exercise in another exercise mode. The test order will be random. After at least 12 times of cardiopulmonary rehabilitation training, the test will be performed again.
- Conditions
- Coronary Artery Disease
- Being tested
- exercise
- Keywords
- coronary artery disease, blood pressure, rehabilitation, exercise mode
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseOther
The test order will be random. After at least 12 times of cardiopulmonary rehabilitation training, the test will be performed again.
| Study group | Role | What they receive |
|---|---|---|
| patients with coronary artery diseases | Experimental | The investigators will recruit 30 subjects with CAD who are referred to phase II cardiopulmonary rehabilitation exercise training. After at least 3 times of familiar with the cardiopulmonary rehabilitation training machine, the subjects performed the treadmill or stationary bicycle and exercise to personalized target heart rate for 10 minutes, take a rest until the heart rate recover to the resting heart rate, and then repeated the exercise in another exercise mode. Receives: Other: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
heart rate
heart rate
Measured: Change from baseline heart rate at 6 weeks
blood pressure
blood pressure
Measured: Change from baseline blood pressure at 6 weeks
Secondary outcomes (2)
perceived exertion scale
how effort the participant feel. Range from 1to 10. Higher values represent harder.
Measured: baseline and 6 weeks
heart rate variability
heart rate variability
Measured: baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start11 Mar 2019
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT03847012
- Sponsor's protocol ID
- 201807117RIND
- Status last verified
- Apr 2021
- First submitted
- 10 Feb 2019
- Last updated
- 8 Apr 2021
- 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 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Blood Pressure Responses to Different Exercise Models in Patients With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT03847012
- Acronym / sponsor ID
- 201807117RIND
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery disease, blood pressure, rehabilitation, exercise mode
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 11 Mar 2019 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 20 Feb 2019 (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.
The purposes of this study were to compare blood pressure responses of the same target heart rate on different exercise modes in patients with coronary artery diseases (CAD) and to compare the effects of blood pressure responses after exercise training.
The investigators will recruit 30 subjects with CAD who are referred to phase II cardiopulmonary rehabilitation exercise training. The subjects performed the treadmill or stationary bicycle exercise randomly.
Detailed description
Considering cardiopulmonary rehabilitation intensity is often setting by heart rate clinically, and only few study focused on exercise responses patients with CAD, the purposes of this study were to compare blood pressure responses of the same target heart rate on different exercise modes in patients with CAD and to compare the effects of blood pressure responses after exercise training.
This is a crossover trial study. The investigators will recruit 30 subjects with CAD who are referred to phase II cardiopulmonary rehabilitation exercise training. After at least 3 times of familiar with the cardiopulmonary rehabilitation training machine, the subjects performed the treadmill or stationary bicycle and exercise to personalized target heart rate for 10 minutes, take a rest until the heart rate recover to the resting heart rate, and then repeated the exercise in another exercise mode. The test order will be random. After at least 12 times of cardiopulmonary rehabilitation training, the test will be performed again.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with coronary artery diseases | Experimental | Other: exerciseThe investigators will recruit 30 subjects with CAD who are referred to phase II cardiopulmonary rehabilitation exercise training. After at least 3 times of familiar with the cardiopulmonary rehabilitation training machine, the subjects performed the treadmill or stationary bicycle and exercise to personalized target heart rate for 10 minutes, take a rest until the heart rate recover to the resting heart rate, and then repeated the exercise in another exercise mode. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with coronary artery diseases who are referred to phase II cardiopulmonary rehabilitation exercise training.
Key exclusion criteria (3 listed)
- patients with non-coronary artery diseases
- atrial fibrillation
- neurological or musculoskeletal problems
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 |
|---|---|---|
| exerciseThe test order will be random. After at least 12 times of cardiopulmonary rehabilitation training, the test will be performed again. | Other | patients with coronary artery diseases |
Primary outcome
heart rate
Time frame: Change from baseline heart rate at 6 weeks
heart rate
blood pressure
Time frame: Change from baseline blood pressure at 6 weeks
blood pressure
2 secondary outcomes
perceived exertion scale
Time frame: baseline and 6 weeks
heart rate variability
Time frame: baseline and 6 weeks
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 8 Apr 2021.
- 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 exercise in people with Coronary Artery Disease, 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 3 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 8 Apr 2021. 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?
heart rate (time frame: Change from baseline heart rate at 6 weeks). The study lists 2 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 8 Apr 2021.