Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000888369
Ethics application status
Approved
Date submitted
28/04/2017
Date registered
16/06/2017
Date last updated
16/06/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Application of the 6-minute walk test for exercise prescription in patients with cardiopulmonary disease
Scientific title
Identifying the optimal individualized exercise prescription for patients with cardiopulmonary disease by comparing the the parameters of 6-minute walk test and parameters of cardiopulmonary exercise testing related to exercise prescription
Secondary ID [1] 291784 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients with cardiopulmonary disease 303014 0
Condition category
Condition code
Physical Medicine / Rehabilitation 302471 302471 0 0
Physiotherapy
Cardiovascular 302690 302690 0 0
Other cardiovascular diseases
Respiratory 302691 302691 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
All subjects will perform once: (1) cardiopulmonary exercise testing by a doctor and (2) 6-minute walk test by a physiotherapist. The interval of these two tests will not exceed 3 weeks.
The cardiopulmonary exercise test is performed on a stationary bicycle with modified Bruce protocol, During the test various pieces of equipment will be used to monitor your body’s response. This equipment includes: face mask, EKG monitor, blood pressure cuff, and pulse oximeter. A Cardiopulmonary Exercise Test may take 45 to 60 minutes to complete. The rest, exercise, and recovery lasts for a total of about 15-25 minutes, To get the most accurate results, subjects will be request to give their best effort for as long as they possibly can.

The 6-minute walk test is conducted on a straight 20 meter track, Subjects will be asked to walk back and forth in this track for 6 minutes. When the test finished, we will measure the total distance an individual is able to walk, heart rate change, blood pressure change during the test.
Intervention code [1] 297906 0
Not applicable
Comparator / control treatment
Cardiopulmonary exercise test
Control group
Active

Outcomes
Primary outcome [1] 301903 0
The total distance walk in 6 minutes (6MWD)
Timepoint [1] 301903 0
Baseline
Primary outcome [2] 302236 0
The heart rate change during 6-minute walk tests, assessed by POLAR heart sensor
Timepoint [2] 302236 0
Baseline
Primary outcome [3] 302239 0
The systolic blood pressure change during 6-minute walk test measured by Ostar blood pressure monitor
Timepoint [3] 302239 0
Baseline
Secondary outcome [1] 334245 0
Maximal oxygen consumption (peak VO2) during cardiopulmonary exercise test (CPET), assessed by Cortex metabolic system


Timepoint [1] 334245 0
Baseline
Secondary outcome [2] 335251 0
Anaerobic threshold oxygen consumption (AT VO2) during cardiopulmonary exercise test (CPET) assessed by Cortex metabolic system
Timepoint [2] 335251 0
Baseline
Secondary outcome [3] 335822 0
Maximal heart rate in cardiopulmonary exercise test assessed by EKG monitor
Timepoint [3] 335822 0
Baseline
Secondary outcome [4] 335826 0
Heart rate at anaerobic threshold in cardiopulmonary exercise test assessed by EKG monitor
Timepoint [4] 335826 0
Baseline
Secondary outcome [5] 335827 0
Primary outcome 4:
The mean speed of 6-minute walk test calculated from the primary outcome 1: total distance of 6-minute walk test

The mean speed of 6-minute walk test= total distance of 6-minute walk test/6 mins
Timepoint [5] 335827 0
Baseline

Eligibility
Key inclusion criteria
Patients with cardiac or pulmonary disease aged above 20 years old with stable medical condition will be include in this study.
Minimum age
20 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Women with pregnancy
2. Patients couldn’t complete the 6-minute walk test or cardiopulmonary exercise testing
3. Patients with neurological or orthopaedic diseases will affect ambulatory ability or ambulation with assistive devices
4. An acute cardiac event happened less than one week
5. Unstable angina happened in one month
6. Resting heart rate greater than or equal to 120 beats/min
7. Resting systolic blood pressure greater than or equal to 180mmHg ; or resting diastolic greater than or equal to 100mmHg

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Canonical Analysis, univariate analysis and multiple linear regression

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
2/11/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment outside Australia
Country [1] 8851 0
Taiwan, Province Of China
State/province [1] 8851 0
New Taipei City

Funding & Sponsors
Funding source category [1] 296287 0
Hospital
Name [1] 296287 0
Taipei Medical University Shuang Ho Hospital
Country [1] 296287 0
Taiwan, Province Of China
Funding source category [2] 296440 0
University
Name [2] 296440 0
University of Taipei, Tien-Mu Campus
Country [2] 296440 0
Taiwan, Province Of China
Primary sponsor type
Individual
Name
Chien-Ju Lin
Address
No.291, Zhongzheng Rd., Zhonghe District, New Taipei City, 23561, Taiwan(R.O.C.)
Taipei Medical University Shuang Ho Hospital
Department of Physical Medicine and Rehabilitation
Country
Taiwan, Province Of China
Secondary sponsor category [1] 295223 0
None
Name [1] 295223 0
Address [1] 295223 0
Country [1] 295223 0
Other collaborator category [1] 279547 0
Hospital
Name [1] 279547 0
Taipei Medical University-Shuang Ho Hospital
Address [1] 279547 0
No.291, Zhongzheng Rd., Zhonghe District, New Taipei City, 23561, Taiwan(R.O.C.)
Country [1] 279547 0
Taiwan, Province Of China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297520 0
Taipei Medical University Joint Institutional Review Board
Ethics committee address [1] 297520 0
17F., No.172-1, Sec. 2, Keelung Rd., Daan Dist., Taipei City 110, Taiwan (R.O.C.)
Ethics committee country [1] 297520 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 297520 0
12/08/2016
Approval date [1] 297520 0
21/10/2016
Ethics approval number [1] 297520 0
N201609018

Summary
Brief summary
6-minute is a simple, reliable and popular field test for fitness assessment and prognostic prediction, however, its application for exercise prescription remains limited and unsatisfied. So, this study purpose is to identify the optimal individualized exercise prescription by using the results of 6-minute walk test among patients with cardiopulmonary diseases. A comprehensive model will be made to meet the individual's needs for training effect and will be an alternative method to prescribe training dosage, especially when cardiopulmonary exercise testing is not available.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74306 0
Miss Chien-Ju, Lin
Address 74306 0
No.291, Zhongzheng Rd., Zhonghe District, New Taipei City, 23561, Taiwan(R.O.C.)
Taipei Medical University-Shuang Ho Hospital
Department of Physical Medicine and Rehabilitation
Country 74306 0
Taiwan, Province Of China
Phone 74306 0
+886-2-2249-0088
Fax 74306 0
+886-2-2248-0577
Email 74306 0
[email protected]
Contact person for public queries
Name 74307 0
Miss Chien-Ju, Lin
Address 74307 0
No.291, Zhongzheng Rd., Zhonghe District, New Taipei City, 23561, Taiwan(R.O.C.)
Taipei Medical University-Shuang Ho Hospital
Department of Physical Medicine and Rehabilitation
Country 74307 0
Taiwan, Province Of China
Phone 74307 0
+886-2-2249-0088
Fax 74307 0
+886-2-2248-0577
Email 74307 0
[email protected]
Contact person for scientific queries
Name 74308 0
A/Prof Mei-Wun, Tsai
Address 74308 0
No.155, Sec.2, Linong Street, Taipei, 11221 Taiwan (ROC)
National Yang-Ming University
Physical Therapy and Assistive Technology
Country 74308 0
Taiwan, Province Of China
Phone 74308 0
+886-2-2826-7939
Fax 74308 0
Email 74308 0
[email protected]

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