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

NCT04715659 | Unknown DMC

• 1 other identifier: reabilitar_DPOC
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Keywords

validity; reliability; pulmonary rehabilitation

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (4)

• Dyspnea during the tests

  Through test completion, duration of the tests 6 and 15 minutes

• Fatigue during the tests

  Through test completion, duration of the tests 6 and 15 minutes

• Heart rate during the tests

  Through test completion, duration of the tests 6 and 15 minutes

• Oxygen saturation during the tests

  Through test completion, duration of the tests 6 and 15 minutes

Study Arms (1)

COPD patients

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

Interventions

Performance of step test (number of steps) for the assessment of exercise capacity DIAGNOSTIC_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.

COPD patients

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients are eligible with a diagnose of chronic obstructive pulmonary disease (COPD).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Polytechnic Institute of Porto: lead
• Nippon Gases Portugal: collaborator

Study Sites (1)

Rui Vilarinho

Porto, 4200-072, Portugal

RECRUITING

Related Publications (2)

• 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.

  PMID: 38326260 DERIVED

• 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.

  PMID: 35387847 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Rui A Vilarinho, Master

CONTACT

222061000; rav@ess.ipp.pt

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 3, 2021
• First Posted: January 20, 2021
• Study Start: January 4, 2021
• Primary Completion: July 30, 2021
• Study Completion: December 31, 2023
• Last Updated: May 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)