Clinical trial NCT04715659: A Novel Incremental Step Test as an Alternative for the Assessment of Exercise Capacity in Patients With COPD
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COPD
Keywords: validity
reliability
pulmonary rehabilitation
Lead sponsor: Polytechnic Institute of Porto
Sponsor class: OTHER
Collaborators: name: Nippon Gases Portugal
First posted: 2021-01-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients attending a pneumology consultation at the hospital will be asked for permission to be contacted about the study. Those who agree will be seen by the principal investigator who will explain the nature of the study and assess eligibility for the study.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of steps
timeFrame: Through test completion, duration of the test 15 minutes
measure: Distance walked
timeFrame: Through test completion, duration of the test 6 minutes
measure: Distance walked
timeFrame: Through test completion, duration of the test 12 minutes
Secondary outcomes:
measure: Dyspnea during the tests
timeFrame: Through test completion, duration of the tests 6 and 15 minutes
measure: Fatigue during the tests
timeFrame: Through test completion, duration of the tests 6 and 15 minutes
measure: Heart rate during the tests
timeFrame: Through test completion, duration of the tests 6 and 15 minutes
measure: Oxygen saturation during the tests
timeFrame: Through test completion, duration of the tests 6 and 15 minutes
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Rui Vilarinho
Study officials:
References:
citation: Vilarinho R, Serra L, Aguas A, Alves C, Silva PM, Caneiras C, Montes AM. Validity and reliability of a new incremental step test for people with chronic obstructive pulmonary disease. BMJ Open Respir Res. 2022 Apr;9(1):e001158. doi: 10.1136/bmjresp-2021-001158.