- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04715659
A Novel Incremental Step Test as an Alternative for the Assessment of Exercise Capacity in Patients With COPD
A Novel Incremental Step Test as an Alternative for the Assessment of Exercise Capacity in Patients With COPD - The Study of Its Measurement Properties
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The primary aim of this project is to develop and determine the measurement properties (validity and reliability) of a novel step test for the assessment of exercise capacity in patients with COPD.
The investigators will perform two cross-sectional studies for validity and reliability in patients with COPD. Participants attending a pneumology consultation at the hospital will be asked for permission to be contacted about the study. The participants who agree will be seen by the principal investigator who will explain the nature of the study and assess eligibility for the study. The participants will sign informed consent.
The validity study will be performed in two days (separated >48h). During the first session, the participants will perform the 6-minute walk test (6MWT) twice (a valid test for COPD). On the second day, the step test will be performed twice.
The reliability study will be performed in two days (separated for 7 days). On both days, the step test will be performed one time.
The investigators predict that 50 patients with COPD will be followed in each study (validity and reliability).
The investigators hypothesize that the step test can be a good option to apply in pulmonary rehabilitation programs with good measurement properties for the assessment of exercise capacity in COPD patients. The validation of the test can contribute to applying the step modality in the exercise training as an alternative for the prescription of the exercise intensity. For that, the investigators also hypothesize that the test can be reliable and one test must be enough for the assessment of the patients.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Rui A Vilarinho, Master
- Phone Number: +351 222061000
- Email: rav@ess.ipp.pt
Study Locations
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Porto, Portugal, 4200-072
- Recruiting
- Rui Vilarinho
-
Contact:
- Rui Vilarinho
- Phone Number: 917521184
- Email: ruivilarinho1@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients are eligible with a diagnose of chronic obstructive pulmonary disease (COPD).
Exclusion Criteria:
- Patients will be excluded if they have a significant cardiac, immune, musculoskeletal or neurological impairment, or any other that does not allow them to perform the tests.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
COPD patients
|
The development of the step test will be designed according to the characteristics of other validated field tests - the walking tests (6-minute walk test and the incremental shuttle walking test) The step test will be performed on a 20 cm tall, single-step device with no handles. The criteria for stopping the test will be the same as described in standard operating procedures for the walking field tests, with the addition of the inability to follow the work rate for a period of 10 seconds. The main outcome of the test will be the highest number of steps and work rate achieved. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of steps
Time Frame: Through test completion, duration of the test 15 minutes
|
The primary outcome will be the amount of the number of steps performed in the step test
|
Through test completion, duration of the test 15 minutes
|
Distance walked
Time Frame: Through test completion, duration of the test 6 minutes
|
The primary outcome will be the distance walked performed in the 6-minute walk test
|
Through test completion, duration of the test 6 minutes
|
Distance walked
Time Frame: Through test completion, duration of the test 12 minutes
|
The primary outcome will be the distance walked performed in the incremental shuttle walk test
|
Through test completion, duration of the test 12 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dyspnea during the tests
Time Frame: Through test completion, duration of the tests 6 and 15 minutes
|
Dyspnea experienced during the tests, monitored with the modified Borg scale, that ranges from 0 to 10, where 0 represents no dyspnea and 10 the worst dyspnea.
|
Through test completion, duration of the tests 6 and 15 minutes
|
Fatigue during the tests
Time Frame: Through test completion, duration of the tests 6 and 15 minutes
|
Fatigue experienced during the tests, monitored with the modified Borg scale, that ranges from 0 to 10, where 0 represents no fatigue and 10 the worst fatigue
|
Through test completion, duration of the tests 6 and 15 minutes
|
Heart rate during the tests
Time Frame: Through test completion, duration of the tests 6 and 15 minutes
|
Heart rate assessed during the tests, monitored with a cardiofrequencimeter
|
Through test completion, duration of the tests 6 and 15 minutes
|
Oxygen saturation during the tests
Time Frame: Through test completion, duration of the tests 6 and 15 minutes
|
Oxygen saturation assessed during the tests, monitored with a pulse oximeter
|
Through test completion, duration of the tests 6 and 15 minutes
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
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
Keywords
Other Study ID Numbers
- reabilitar_DPOC
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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