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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04801979
Enrollment
150
Registered
2021-03-17
Start date
2021-05-30
Completion date
2022-12-30
Last updated
2023-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adults Without Disabilities

Keywords

Normative values, Reference equations, Step test, Exercise capacity

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.

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.

Interventions

DIAGNOSTIC_TESTIncremental Step 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.

Sponsors

Nippon Gases Portugal
CollaboratorUNKNOWN
Polytechnic Institute of Porto
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of stepsThrough test completion, duration of the test 15 minutesThe primary outcome will be the amount of steps performed in the step test

Secondary

MeasureTime frameDescription
Dyspnea during the testsThrough test completion, duration of the test 15 minutesDyspnea 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.
Fatigue during the testsThrough test completion, duration of the tests 15 minutesFatigue 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
Heart rate during the testsThrough test completion, duration of the tests 15 minutesHeart rate assessed during the tests, monitored with a cardiofrequencimeter
Oxygen saturation during the testsThrough test completion, duration of the tests 15 minutesOxygen saturation assessed during the tests, monitored with a pulse oximeter

Countries

Portugal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026