A Novel Incremental Step Test as an Alternative for the Assessment of Exercise Capacity in Patients With COPD

COPD Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04715659
• Other study ID #: reabilitar_DPOC
• Status: Recruiting
• Start date: January 4, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2023
• Source: Polytechnic Institute of Porto
• Contact: Rui A Vilarinho, Master
• Phone: 222061000
• Email: rav[@]ess.ipp.pt
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2023
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• COPD

Intervention

Diagnostic Test:
• Performance of step test (number of steps) for the assessment of exercise capacity
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.

Locations

Country	Name	City	State
Portugal	Rui Vilarinho	Porto

Sponsors (2)

Lead Sponsor	Collaborator
Polytechnic Institute of Porto	Nippon Gases Portugal

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of steps	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
Primary	Distance walked	The primary outcome will be the distance walked performed in the 6-minute walk test	Through test completion, duration of the test 6 minutes
Primary	Distance walked	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	Dyspnea during the tests	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
Secondary	Fatigue during the tests	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
Secondary	Heart rate during the tests	Heart rate assessed during the tests, monitored with a cardiofrequencimeter	Through test completion, duration of the tests 6 and 15 minutes
Secondary	Oxygen saturation during the tests	Oxygen saturation assessed during the tests, monitored with a pulse oximeter	Through test completion, duration of the tests 6 and 15 minutes