An observational study in COPD, sponsored by Polytechnic Institute of Porto. Recruiting at 1 site in Portugal. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-05-09.
Sponsored by Polytechnic Institute of Porto · Observational
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.
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.
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
This study's planned enrollment of 50 is below the median of 158 across 1,497 observational studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Polytechnic Institute of Porto is the lead sponsor of 14 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Number of steps
The primary outcome will be the amount of the number of steps performed in the step test
Time frame: Through test completion, duration of the test 15 minutes
Distance walked
The primary outcome will be the distance walked performed in the 6-minute walk test
Time frame: Through test completion, duration of the test 6 minutes
Distance walked
The primary outcome will be the distance walked performed in the incremental shuttle walk test
Time frame: Through test completion, duration of the test 12 minutes
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.
Time frame: Through test completion, duration of the tests 6 and 15 minutes
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
Time frame: Through test completion, duration of the tests 6 and 15 minutes
Heart rate during the tests
Heart rate assessed during the tests, monitored with a cardiofrequencimeter
Time frame: Through test completion, duration of the tests 6 and 15 minutes
Oxygen saturation during the tests
Oxygen saturation assessed during the tests, monitored with a pulse oximeter
Time frame: Through test completion, duration of the tests 6 and 15 minutes
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pulmonary Disease, Chronic Obstructive →
Polytechnic Institute of Porto