COPDNCT04715659
A Novel Incremental Step Test as an Alternative for the Assessment of Exercise Capacity in Patients With COPD
An observational study of COPD, run by Polytechnic Institute of Porto at 1 site in Portugal.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- COPD
- What is being tested?
- Performance of step test (number of steps) for the assessment of exercise capacity
- How many people
- 50 participants
- Where
- 1 sitePortugal
- Study dates
- 4 Jan 2021to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients are eligible with a diagnose of chronic obstructive pulmonary disease (COPD).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Rui Vilarinho
Porto, 4200-072
Rui Vilarinho, 917521184, ruivilarinho1@gmail.com
About this study
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
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.
Read the 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.
- Conditions
- COPD
- Being tested
- Performance of step test (number of steps) for the assessment of exercise capacity
- Keywords
- validity, reliability, pulmonary rehabilitation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Performance of step test (number of steps) for the assessment of exercise capacityDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| COPD patients | Not described Receives: Diagnostic Test: Performance of step test (number of steps) for the assessment of exercise capacity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of steps
The primary outcome will be the amount of the number of steps performed in the step test
Measured: 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
Measured: 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
Measured: Through test completion, duration of the test 12 minutes
Secondary outcomes (4)
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.
Measured: 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
Measured: 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
Measured: 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
Measured: Through test completion, duration of the tests 6 and 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start4 Jan 2021
- Primary completion30 Jul 2021
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Polytechnic Institute of Porto
- Sponsor type
- University, hospital or other
- Collaborators
- Nippon Gases Portugal
- Responsible party
- Principal investigator, Rui Vilarinho, Polytechnic Institute of Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04715659
- Sponsor's protocol ID
- reabilitar_DPOC
- Status last verified
- May 2023
- First submitted
- 3 Jan 2021
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Goncalves T, Carlos Winck J, Silva F, Caneiras C, Montes AM, Vilarinho R. Measurement properties of the incremental step test for people with chronic obstructive pulmonary disease: a cross-sectional study. BMJ Open. 2024 Feb 7;14(2):e078425. doi: 10.1136/bmjopen-2023-078425.
PubMed 38326260Vilarinho 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.
PubMed 35387847
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04715659
- Acronym / sponsor ID
- reabilitar_DPOC
- Conditions
- COPD
- Keywords
- validity, reliability, pulmonary rehabilitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Polytechnic Institute of PortoUniversity, hospital or other
- Collaborators
- Nippon Gases Portugal
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 20 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD patients | – | Diagnostic Test: Performance of step test (number of steps) for the assessment of exercise capacity |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients are eligible with a diagnose of chronic obstructive pulmonary disease (COPD).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Performance of step test (number of steps) for the assessment of exercise capacityThe 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. | Diagnostic test | COPD patients |
Primary outcome
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
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
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
4 secondary outcomes
Dyspnea during the tests
Time frame: 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
Heart rate during the tests
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Derived from this study: PubMed 38326260Goncalves T, Carlos Winck J, Silva F, Caneiras C, Montes AM, Vilarinho R. Measurement properties of the incremental step test for people with chronic obstructive pulmonary disease: a cross-sectional study. BMJ Open. 2024 Feb 7;14(2):e078425. doi: 10.1136/bmjopen-2023-078425.
- Derived from this study: PubMed 35387847Vilarinho 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.
- Individual participant dataSharing planned: No
Related trials for COPD
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Not yet recruiting
Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
Not yet recruitingPhase 3
The AIRWARD Study: A Study to Test Whether Verducatib Helps People With Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease
RecruitingPhase 2
Phase 2b Efficacy and Safety Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients
COPD, Chronic Obstructive Pulmonary Disease (COPD)
Not yet recruitingObservational study
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
Pulmonary Disease, Chronic Obstructive (COPD), Hypercapnia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, run by Polytechnic Institute of Porto at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rui A Vilarinho, Master (222061000 ext. +351, rav@ess.ipp.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of steps (time frame: Through test completion, duration of the test 15 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04715659, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.