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Clinical Trials/NCT04801979
NCT04801979CompletedNot Applicable

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

Polytechnic Institute of Porto1 site in 1 country150 target enrollmentStarted: May 30, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
150
Locations
1
Primary Endpoint
Number of steps

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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

Outcomes

Primary Outcomes

Number of steps

Time Frame: Through test completion, duration of the test 15 minutes

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

Secondary Outcomes

  • Heart rate during the tests(Through test completion, duration of the tests 15 minutes)
  • Fatigue during the tests(Through test completion, duration of the tests 15 minutes)
  • Dyspnea during the tests(Through test completion, duration of the test 15 minutes)
  • Oxygen saturation during the tests(Through test completion, duration of the tests 15 minutes)

Investigators

Sponsor
Polytechnic Institute of Porto
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Rui Vilarinho

Principal Investigator

Polytechnic Institute of Porto

Study Sites (1)

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