Normative Values and Reference Equations of a New Incremental Step Test for the Assessment of Exercise Capacity for Portuguese Adults

NCT04801979 | Completed

• 1 other identifier: New_Step_Test
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

According to the official guidelines, a range of settings for cardiorespiratory rehabilitation, including the community- and home-based models, are considered to answer to the inadequate number of rehabilitation services, especially at hospitals, and, also, to respond to the patients' needs. For these settings outside the hospitals, new strategies for the assessment of exercise capacity and exercise training are essential. The modality of stepping 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 establishment of normative values and reference equations generated from data of populations without disabilities to aim to characterize a defined population at a specific period of time, and evaluate and compare an individual's performance within a population.

Conditions

Adults Without Disabilities

Keywords

Normative values; Reference equations; Step test; Exercise capacity

Outcome Measures

Primary Outcomes (1)

• Number of steps

  The primary outcome will be the amount of steps performed in the step test

  Through test completion, duration of the test 15 minutes

Secondary Outcomes (4)

• Dyspnea during the tests

  Through test completion, duration of the test 15 minutes

• Fatigue during the tests

  Through test completion, duration of the tests 15 minutes

• Heart rate during the tests

  Through test completion, duration of the tests 15 minutes

• Oxygen saturation during the tests

  Through test completion, duration of the tests 15 minutes

Interventions

Incremental Step Test DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Portuguese adults (over 18 years) without disabilities will be included through an advertisement at the university campus and surrounding areas. Interested participants can contact the research team for participation. 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.

You may qualify if:

• Portuguese nacionality
• Adults without disabilities aged \>18 years
• Participants with body mass index between 18 and 30 kg/m2

You may not qualify if:

• Acute or chronic conditions (respiratory disease, cardiac disease, signs of cognitive or neuromuscular impairment, and significant musculoskeletal disorder)
• Conditions that could interfere with the ability to perform the step test
• Use of walking aids
• Post-symptomatic COVID-19 infected participants
• High-performance athletes

Sponsors & Collaborators

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

Study Sites (1)

Rui Vilarinho

Porto, 4200-072, Portugal

Location

Study Design

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

Study Record Dates

• First Submitted: March 13, 2021
• First Posted: March 17, 2021
• Study Start: May 30, 2021
• Primary Completion: July 20, 2021
• Study Completion: December 30, 2022
• Last Updated: May 9, 2023

Record last verified: 2023-05

Locations

PT (1)