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

Adults Without Disabilities Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04801979
• Other study ID #: New_Step_Test
• Status: Completed
• Start date: May 30, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: May 2023
• Source: Polytechnic Institute of Porto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 30, 2022
• Est. primary completion date: July 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adults Without Disabilities

Intervention

Diagnostic Test:
• Incremental 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.

Locations

Country	Name	City	State
Portugal	Rui Vilarinho	Porto

Sponsors (2)

Lead Sponsor	Collaborator
Polytechnic Institute of Porto	Nippon Gases Portugal

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Heart rate during the tests	Heart rate assessed during the tests, monitored with a cardiofrequencimeter	Through test completion, duration of the tests 15 minutes
Secondary	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