- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03847012
Blood Pressure Responses to Different Exercise Modes in Coronary Artery Disease
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.
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Taipei city, Taiwan, 100
- National Taiwan University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- patients with coronary artery diseases who are referred to phase II cardiopulmonary rehabilitation exercise training.
Exclusion Criteria:
- patients with non-coronary artery diseases
- atrial fibrillation
- neurological or musculoskeletal problems
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: patients with coronary artery diseases
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
heart rate
Time Frame: Change from baseline heart rate at 6 weeks
|
heart rate
|
Change from baseline heart rate at 6 weeks
|
|
blood pressure
Time Frame: Change from baseline blood pressure at 6 weeks
|
blood pressure
|
Change from baseline blood pressure at 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
perceived exertion scale
Time Frame: baseline and 6 weeks
|
how effort the participant feel.
Range from 1to 10.
Higher values represent harder.
|
baseline and 6 weeks
|
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heart rate variability
Time Frame: baseline and 6 weeks
|
heart rate variability
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baseline and 6 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
age
Time Frame: baseline
|
questionnaire
|
baseline
|
|
gender
Time Frame: baseline
|
questionnaire
|
baseline
|
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risk level of exercise
Time Frame: baseline
|
AACVPR Stratification Algorithm for Risk of Event.
Include high, moderate and low risk
|
baseline
|
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co-morbidity
Time Frame: baseline
|
questionnaire
|
baseline
|
|
medication
Time Frame: baseline
|
questionnaire
|
baseline
|
|
level of exercise intensity
Time Frame: baseline
|
percent of heart rate reserve
|
baseline
|
Collaborators and Investigators
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
- 201807117RIND
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.
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