Blood Pressure Responses to Different Exercise Modes in Coronary Artery Disease

April 7, 2021 updated by: National Taiwan University Hospital

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

Status

Completed

Intervention / Treatment

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

Interventional

Enrollment (Actual)

30

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 Locations

      • Taipei city, Taiwan, 100
        • National Taiwan University Hospital

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

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

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: 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
heart rate variability
Time Frame: baseline and 6 weeks
heart rate variability
baseline and 6 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
age
Time Frame: baseline
questionnaire
baseline
gender
Time Frame: baseline
questionnaire
baseline
risk level of exercise
Time Frame: baseline
AACVPR Stratification Algorithm for Risk of Event. Include high, moderate and low risk
baseline
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

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)

March 11, 2019

Primary Completion (Actual)

September 30, 2020

Study Completion (Actual)

September 30, 2020

Study Registration Dates

First Submitted

February 10, 2019

First Submitted That Met QC Criteria

February 17, 2019

First Posted (Actual)

February 20, 2019

Study Record Updates

Last Update Posted (Actual)

April 8, 2021

Last Update Submitted That Met QC Criteria

April 7, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

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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