Adults Without DisabilitiesNCT04801979
Normative Values and Reference Equations of a New Incremental Step Test for the Assessment of Exercise Capacity for Portuguese Adults
An observational study of Adults Without Disabilities, run by Polytechnic Institute of Porto at 1 site in Portugal.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adults Without Disabilities
- What is being tested?
- Incremental Step Test
- How many people
- 150 participants
- Where
- 1 sitePortugal
- Study dates
- 30 May 2021to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Portuguese nacionality
- Adults without disabilities aged >18 years
- Participants with body mass index between 18 and 30 kg/m2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Adults Without Disabilities
- Being tested
- Incremental Step Test
- Keywords
- Normative values, Reference equations, Step test, Exercise capacity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incremental Step TestDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of steps
The primary outcome will be the amount of steps performed in the step test
Measured: Through test completion, duration of the test 15 minutes
Secondary outcomes (4)
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.
Measured: 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
Measured: Through test completion, duration of the tests 15 minutes
Heart rate during the tests
Heart rate assessed during the tests, monitored with a cardiofrequencimeter
Measured: 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
Measured: Through test completion, duration of the tests 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start30 May 2021
- Primary completion20 Jul 2021
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adults Without DisabilitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Polytechnic Institute of Porto
- Sponsor type
- University, hospital or other
- Collaborators
- Nippon Gases Portugal
- Responsible party
- Principal investigator, Rui Vilarinho, Polytechnic Institute of Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04801979
- Sponsor's protocol ID
- New_Step_Test
- Status last verified
- May 2023
- First submitted
- 13 Mar 2021
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normative Values and Reference Equations of a New Incremental Step Test for the Assessment of Exercise Capacity for Portuguese Adults
- ClinicalTrials.gov ID
- NCT04801979
- Acronym / sponsor ID
- New_Step_Test
- Conditions
- Adults Without Disabilities
- Keywords
- Normative values, Reference equations, Step test, Exercise capacity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Polytechnic Institute of PortoUniversity, hospital or other
- Collaborators
- Nippon Gases Portugal
- Study start
- 30 May 2021 (actual)
- Primary completion
- 20 Jul 2021 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 17 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Portuguese nacionality
- Adults without disabilities aged >18 years
- Participants with body mass index between 18 and 30 kg/m2
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Incremental Step TestPerformance 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. | Diagnostic test | – |
Primary outcome
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
4 secondary outcomes
Dyspnea during the tests
Time frame: Through test completion, duration of the test 15 minutes
Fatigue during the tests
Time frame: Through test completion, duration of the tests 15 minutes
Heart rate during the tests
Time frame: Through test completion, duration of the tests 15 minutes
Oxygen saturation during the tests
Time frame: Through test completion, duration of the tests 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adults Without Disabilities, run by Polytechnic Institute of Porto at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of steps (time frame: Through test completion, duration of the test 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.