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Blood Pressure Responses to Different Exercise Modes in Coronary Artery Disease

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
exercise
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Coronary Artery Disease focused on measuring coronary artery disease, blood pressure, rehabilitation, exercise mode

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

patients with coronary artery diseases

Arm Description

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.

Outcomes

Primary Outcome Measures

heart rate
heart rate
blood pressure
blood pressure

Secondary Outcome Measures

perceived exertion scale
how effort the participant feel. Range from 1to 10. Higher values represent harder.
heart rate variability
heart rate variability

Full Information

First Posted
February 10, 2019
Last Updated
April 7, 2021
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03847012
Brief Title
Blood Pressure Responses to Different Exercise Modes in Coronary Artery Disease
Official Title
The Blood Pressure Responses to Different Exercise Models in Patients With Coronary Artery Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
March 11, 2019 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
coronary artery disease, blood pressure, rehabilitation, exercise mode

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patients with coronary artery diseases
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
exercise
Intervention Description
The test order will be random. After at least 12 times of cardiopulmonary rehabilitation training, the test will be performed again.
Primary Outcome Measure Information:
Title
heart rate
Description
heart rate
Time Frame
Change from baseline heart rate at 6 weeks
Title
blood pressure
Description
blood pressure
Time Frame
Change from baseline blood pressure at 6 weeks
Secondary Outcome Measure Information:
Title
perceived exertion scale
Description
how effort the participant feel. Range from 1to 10. Higher values represent harder.
Time Frame
baseline and 6 weeks
Title
heart rate variability
Description
heart rate variability
Time Frame
baseline and 6 weeks
Other Pre-specified Outcome Measures:
Title
age
Description
questionnaire
Time Frame
baseline
Title
gender
Description
questionnaire
Time Frame
baseline
Title
risk level of exercise
Description
AACVPR Stratification Algorithm for Risk of Event. Include high, moderate and low risk
Time Frame
baseline
Title
co-morbidity
Description
questionnaire
Time Frame
baseline
Title
medication
Description
questionnaire
Time Frame
baseline
Title
level of exercise intensity
Description
percent of heart rate reserve
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei city
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Blood Pressure Responses to Different Exercise Modes in Coronary Artery Disease

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