HealthyNCT02660450
Relationship Between Aerobic Prescription Methods
A study testing Prescription for Workload, Prescription for Heart Rate and Prescription Self Selected in people with Healthy, run by Universidade Federal do Rio de Janeiro.
Trial summary
Current literature report 3 ways to prescribe and control aerobic training. Such models require comparison to determine if they really provide the same impact training in a prescription. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Prescription for Workload, Prescription for Heart Rate and Prescription Self Selected
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Jul 2016
- Phase
- Interventional
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 at 45 years
- Risk stratification low
- Physically active by American College of Sports Medicine criteria
Who cannot join
- Use of ergogenic resources
- Use of sympatholytic drugs
- Use of stimulants
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Relationship Between Methods of Aerobic Prescription: Heart Rate vs. VO2 Load vs. Self Selected
Current literature report 3 ways to prescribe and control aerobic training. Such models require comparison to determine if they really provide the same impact training in a prescription. The aim of this study is to compare the results of different methods of prescription of aerobic training, ie VO2 workload, heart rate (HR), and load self adjusted by perceived effort (PSE) as well as psychological responses activation, and feel depending on the stimuli offered.
Read the detailed description
36 subjects will undergo two sessions. On the first visit, a maximum aerobic exercise test will be carried on treadmill to determine the maximum oxygen intake and maximum heart rate. Second, the subjects are placed (in a blinded fashion) in 3 situations of moderate effort (60 to 65%) for a total of 5 min and 3 min interval between conditions. In situation 1) will be used to speed regarding the particular metabolic demand from the maximum oxygen intake; In the second situation the reserve of heart rate will be used as reference for prescription aiming to achieve 60-65%; On the last visit will be shown to subjects a perceived effort characterized as moderate and asked to adjust their speed according to the application effort. The final will be recorded each time the FC and the speed and perception of effort that the subject was.
- Conditions
- Healthy
- Being tested
- Prescription for Workload, Prescription for Heart Rate, Prescription Self Selected
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prescription for WorkloadOther
Also called VO2Max
Prescription from 65% VO2max for 5 min of exercise
Prescription for Heart RateOther
Also called Heart Rate
Prescription from 60 - 65% Maximum Heart Rate for 5 min of exercise
Prescription Self SelectedOther
Also called Self Selected
Prescription Self Selected from Perceived exertion at 3 - 4 (moderate) for 5 min of exercise
| Study group | Role | What they receive |
|---|---|---|
| Prescription for Workload | Experimental | Prescription from 65% VO2max for 5 min of exercise Receives: Other: Prescription for Heart Rate; Other: Prescription Self Selected |
| Prescription for Heart Rate | Experimental | Prescription from 60 - 65% Maximum Heart Rate for 5 min of exercise Receives: Other: Prescription for Workload; Other: Prescription Self Selected |
| Prescription Self Selected | Experimental | Prescription Self Selected from Perceived exertion at 3 - 4 (moderate) for 5 min of exercise Receives: Other: Prescription for Workload; Other: Prescription for Heart Rate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response of Heart Rate and perceived Effort through prescriptions for oxygen uptake
Measured: Acute Change in 5 minutes of moderate aerobic exercise
Response of Heart Rate through prescriptions for self selected workload based in perceived effort
Measured: Acute Change in 5 minutes of moderate aerobic exercise
Response of velocity and Perceived Effort through Prescription of Heart Rate
Measured: Acute Change in 5 minutes of moderate aerobic exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2016 (estimated)
- Study startFeb 2016
- Primary completionApr 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alberto Souza de Sá Filho, Universidade Federal do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02660450
- Sponsor's protocol ID
- UNIG 02
- Status last verified
- Jan 2016
- First submitted
- 4 Jan 2016
- Last updated
- 21 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Methods of Aerobic Prescription: Heart Rate vs. VO2 Load vs. Self Selected
- ClinicalTrials.gov ID
- NCT02660450
- Acronym / sponsor ID
- UNIG 02
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 21 Jan 2016 (estimated)
- 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.
Current literature report 3 ways to prescribe and control aerobic training. Such models require comparison to determine if they really provide the same impact training in a prescription. The aim of this study is to compare the results of different methods of prescription of aerobic training, ie VO2 workload, heart rate (HR), and load self adjusted by perceived effort (PSE) as well as psychological responses activation, and feel depending on the stimuli offered.
Detailed description
36 subjects will undergo two sessions. On the first visit, a maximum aerobic exercise test will be carried on treadmill to determine the maximum oxygen intake and maximum heart rate. Second, the subjects are placed (in a blinded fashion) in 3 situations of moderate effort (60 to 65%) for a total of 5 min and 3 min interval between conditions. In situation 1) will be used to speed regarding the particular metabolic demand from the maximum oxygen intake; In the second situation the reserve of heart rate will be used as reference for prescription aiming to achieve 60-65%; On the last visit will be shown to subjects a perceived effort characterized as moderate and asked to adjust their speed according to the application effort. The final will be recorded each time the FC and the speed and perception of effort that the subject was.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prescription for Workload | Experimental | Other: Prescription for Heart Rate, Other: Prescription Self SelectedPrescription from 65% VO2max for 5 min of exercise |
| Prescription for Heart Rate | Experimental | Other: Prescription for Workload, Other: Prescription Self SelectedPrescription from 60 - 65% Maximum Heart Rate for 5 min of exercise |
| Prescription Self Selected | Experimental | Other: Prescription for Workload, Other: Prescription for Heart RatePrescription Self Selected from Perceived exertion at 3 - 4 (moderate) for 5 min of exercise |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18 at 45 years
- Risk stratification low
- Physically active by American College of Sports Medicine criteria
Key exclusion criteria (3 listed)
- Use of ergogenic resources
- Use of sympatholytic drugs
- Use of stimulants
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 |
|---|---|---|
| Prescription for WorkloadAlso: VO2MaxPrescription from 65% VO2max for 5 min of exercise | Other | Prescription Self Selected, Prescription for Heart Rate |
| Prescription for Heart RateAlso: Heart RatePrescription from 60 - 65% Maximum Heart Rate for 5 min of exercise | Other | Prescription Self Selected, Prescription for Workload |
| Prescription Self SelectedAlso: Self SelectedPrescription Self Selected from Perceived exertion at 3 - 4 (moderate) for 5 min of exercise | Other | Prescription for Heart Rate, Prescription for Workload |
Primary outcome
Response of Heart Rate and perceived Effort through prescriptions for oxygen uptake
Time frame: Acute Change in 5 minutes of moderate aerobic exercise
Response of Heart Rate through prescriptions for self selected workload based in perceived effort
Time frame: Acute Change in 5 minutes of moderate aerobic exercise
Response of velocity and Perceived Effort through Prescription of Heart Rate
Time frame: Acute Change in 5 minutes of moderate aerobic exercise
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2016.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Prescription for Workload, Prescription for Heart Rate and Prescription Self Selected in people with Healthy, run by Universidade Federal do Rio de Janeiro.
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 3 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: status not confirmed, as of the sponsor's last update on 21 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sérgio Machado, PhD (55 21 991567006, secm80@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response of Heart Rate and perceived Effort through prescriptions for oxygen uptake (time frame: Acute Change in 5 minutes of moderate aerobic exercise). The study lists 3 primary outcomes in all. 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 21 Jan 2016.