Clinical trial NCT04801979: Normative Values and Reference Equations of a New Incremental Step Test for the Assessment of Exercise Capacity for Portuguese Adults
Official title: Normative Values and Reference Equations of a New Incremental Step Test for the Assessment of Exercise Capacity for Portuguese Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adults Without Disabilities
Keywords: Normative values
Reference equations
Step test
Exercise capacity
Lead sponsor: Polytechnic Institute of Porto
Sponsor class: OTHER
Collaborators: name: Nippon Gases Portugal
First posted: 2021-03-17
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of steps
timeFrame: Through test completion, duration of the test 15 minutes
Secondary outcomes:
measure: Dyspnea during the tests
timeFrame: Through test completion, duration of the test 15 minutes
measure: Fatigue during the tests
timeFrame: Through test completion, duration of the tests 15 minutes
measure: Heart rate during the tests
timeFrame: Through test completion, duration of the tests 15 minutes
measure: Oxygen saturation during the tests
timeFrame: Through test completion, duration of the tests 15 minutes
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Rui Vilarinho
Study officials:
References: