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

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.

Study Overview

• Status: Completed
• Conditions: Adults Without Disabilities
• Intervention / Treatment: Diagnostic test: Incremental Step Test

Detailed Description

The primary aim of this project is to establish normative values and reference equations generated from Portuguese adults without disabilities of a new step test for the assessment of exercise capacity.

The investigators will perform a cross-sectional study in Portuguese adults (over 18 years) without disabilities. The study will be advertised at the university campus, surrounding areas, and 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.

For each participant, the study will be performed in one day. The participants will perform the incremental step test twice (30 minutes apart).

In addition, socio-demographic information (age and sex), anthropometric measures (weight, height, and body mass index), and clinical data (smoking status, comorbidities, and level of physical activity) will be collected.

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Portugal
  • Porto, Portugal, 4200-072
    • Rui Vilarinho

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Through test completion, duration of the test 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	Through test completion, duration of the tests 15 minutes
Heart rate during the tests	Heart rate assessed during the tests, monitored with a cardiofrequencimeter	Through test completion, duration of the tests 15 minutes
Oxygen saturation during the tests	Oxygen saturation assessed during the tests, monitored with a pulse oximeter	Through test completion, duration of the tests 15 minutes

Collaborators and Investigators

• Sponsor: Polytechnic Institute of Porto
• Collaborators: Nippon Gases Portugal

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2021
• Primary Completion (Actual): July 20, 2021
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: March 13, 2021
• First Submitted That Met QC Criteria: March 13, 2021
• First Posted (Actual): March 17, 2021

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Normative values; Reference equations; Step test; Exercise capacity
• Other Study ID Numbers: New_Step_Test

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No