Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2025-12-25 @ 10:52 PM
Study NCT ID:
NCT04715659
Status:
UNKNOWN
Last Update Posted:
2023-05-09
First Post:
2021-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Novel Incremental Step Test as an Alternative for the Assessment of Exercise Capacity in Patients With COPD
Sponsor:
Polytechnic Institute of Porto
Organization:
Study Overview
Official Title:
A Novel Incremental Step Test as an Alternative for the Assessment of Exercise Capacity in Patients With COPD - The Study of Its Measurement Properties
Status:
UNKNOWN
Status Verified Date:
2023-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
According to the official guidelines of pulmonary rehabilitation, a structured home-based approach is recommended to answer to the inadequate number of pulmonary rehabilitation services due to the chronic obstructive pulmonary disease (COPD) patient's needs. For this new setting, new strategies for the assessment of exercise capacity and exercise training are essential. The modality of step can be a promising tool because it is inexpensive, portable, and reflects one of the main activities of daily living (stair climbing). The development of a new field test implies the study of the measurement properties, to facilitate the selection of tests and the interpretation of the results in rehabilitation. This project hypothesizes that the step test can be valid, reliable, and feasible to apply in this new setting of pulmonary rehabilitation.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: