Cardiovascular DiseasePhase 2NCT02351713
Comparison of Exercise Intensity Prescription
A Phase 2 study testing Exercise in people with Cardiovascular Disease, run by Western Colorado University.
Trial summary
Therefore, the purpose of this study is to compare the effectiveness of two exercise training programs for improving cardiorespiratory fitness: the ACE three-zone training model (i.e., threshold based training) versus the more common ACSM recommended relative percent method (i.e., %HRR). It is hypothesized that: 1. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- May 2014to Jan 2015
- Phase
- Phase 2
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants were eligible for inclusion into the study if they were low-to-moderate risk as defined by the ACSM and sedentary.
- Participants were also eligible for inclusion into the study if they verbally agreed to continue previous dietary habits and not perform additional exercise beyond that required for the present study.
Who cannot join
- Exclusionary criteria included evidence of cardiovascular pulmonary, and/or metabolic disease.
About this study
Official title: Is a Threshold-Based Model a Superior Method to the Relative Percent Concept for Establishing Individual Exercise Intensity? A Randomized Controlled Trial
Therefore, the purpose of this study is to compare the effectiveness of two exercise training programs for improving cardiorespiratory fitness: the ACE three-zone training model (i.e., threshold based training) versus the more common ACSM recommended relative percent method (i.e., %HRR).
It is hypothesized that:
- The ACE three-zone training model will elicit greater mean changes in cardiorespiratory fitness (as measured by VO2max) when compared to the relative percent method.
- Participants in the ACE three-zone training model group will be more likely to have favorable VO2max responses; while comparatively, participants in the relative percent method group would be more likely to experience a VO2max nonresponse to exercise training.
Read the detailed description
Cardiorespiratory fitness, typically determined by maximal oxygen uptake (VO2max), is a fundamental measurement for the exercise physiologist and other health professionals. VO2max refers to the highest rate at which oxygen can be taken up and consumed by the body during intense exercise. The "F.I.T.T." principle is an acronym for the four components for exercise prescription: frequency, intensity, time (length), and type of exercise.
Exercise intensity is arguably the most critical component of the exercise prescription model. Failure to meet minimal threshold values may result in lack of a training effect, while too high of an exercise intensity could lead to over-training and negatively impact adherence to an exercise program. The traditional reference standard for prescribing exercise intensity is expressed in terms of percentages of heart rate reserve (%HRR) or oxygen uptake reserve (%VO2R). This is considered the 'relative percent method'. The American College of Sports Medicine (ACSM) currently recommends an exercise intensity of 40-59% HRR/VO2R for improving and maintaining cardiorespiratory fitness. Nevertheless, despite a large evidence base supporting the ACSM relative percent concept recommendation for prescribing exercise intensity, there is concern that the approach consists of a very large range of acceptable percentages and fails to take into account individual metabolic responses to exercises. This study sought to compare the effectiveness of two exercise training programs for improving cardiorespiratory fitness: the ACE three-zone training model (i.e., threshold based training) versus the more common ACSM recommended relative percent concept (i.e., %HRR).
Apparently healthy, but sedentary men and women (n = 42) were randomized to a non-exercise control group or one of two exercise training groups. Exercise training was performed 30 min/day on 5 days/wk for 12wk according to one of two exercise intensity regimens: 1) a relative percent method was used in which intensity was prescribed according to percentages of heart rate reserve (HRR group), or 2) a threshold based method (ACE-3ZM) was used in which intensity was prescribed according to the first ventilatory threshold (VT1) and second ventilatory threshold (VT2).
- Conditions
- Cardiovascular Disease
- Being tested
- Exercise
- Keywords
- primary prevention
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Continuous aerobic exercise prescribed according to two exercise intensity methods: threshold based method (i.e., ventilatory threshold) and relative percent method (i.e., heart rate reserve).
| Study group | Role | What they receive |
|---|---|---|
| Threshold based method | Experimental | Exercise Week 1 Heart rate (HR) < first ventilatory threshold (VT1) 3 days 20 min/day Week 2 HR < VT1 4 days 25 min/day Week 3 HR < VT1 4 days 30 min/day Week 4 HR < VT1 5 days 30 min/day Week 5-6 HR ≥ VT1 to < second ventilatory threshold (VT2) 5 days 30 min/day Weeks 7-8 HR ≥ VT1 to < VT2 5 days 30 min/day Weeks 9-12 HR ≥ VT2 5 days 30 min/day Receives: Other: Exercise |
| Relative percent method | Experimental | Exercise Week 1 40-45% heart rate reserve 3 days 20 min/day Week 2 40-45% heart rate reserve 4 days 25 min/day Week 3 40-45% heart rate reserve 4 days 30 min/day Week 4 40-45% heart rate reserve 5 days 30 min/day Week 5-6 50-55% heart rate reserve 5 days 30 min/day Weeks 7-8 50-55% heart rate reserve 5 days 30min/day Weeks 9-12 60-65% heart rate reserve 5 days 30 min/day Receives: Other: Exercise |
| Control | No intervention | Non-exercise control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal oxygen uptake (VO2max) as a measure of cardiorespiratory fitness
Measured: 12 weeks
Estimate of 10-year Cardiovascular Disease Risk
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2015 (estimated)
- Study startMay 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Colorado University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lance Dalleck, Western Colorado University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02351713
- Sponsor's protocol ID
- WesternSCU
- Status last verified
- Jan 2015
- First submitted
- 22 Jan 2015
- Last updated
- 3 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Wolpern AE, Burgos DJ, Janot JM, Dalleck LC. Is a threshold-based model a superior method to the relative percent concept for establishing individual exercise intensity? a randomized controlled trial. BMC Sports Sci Med Rehabil. 2015 Jul 4;7:16. doi: 10.1186/s13102-015-0011-z. eCollection 2015.
PubMed 26146564
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is a Threshold-Based Model a Superior Method to the Relative Percent Concept for Establishing Individual Exercise Intensity? A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02351713
- Acronym / sponsor ID
- WesternSCU
- Conditions
- Cardiovascular Disease
- Keywords
- primary prevention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Western Colorado UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 30 Jan 2015 (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.
Therefore, the purpose of this study is to compare the effectiveness of two exercise training programs for improving cardiorespiratory fitness: the ACE three-zone training model (i.e., threshold based training) versus the more common ACSM recommended relative percent method (i.e., %HRR).
It is hypothesized that:
- The ACE three-zone training model will elicit greater mean changes in cardiorespiratory fitness (as measured by VO2max) when compared to the relative percent method.
- Participants in the ACE three-zone training model group will be more likely to have favorable VO2max responses; while comparatively, participants in the relative percent method group would be more likely to experience a VO2max nonresponse to exercise training.
Detailed description
Cardiorespiratory fitness, typically determined by maximal oxygen uptake (VO2max), is a fundamental measurement for the exercise physiologist and other health professionals. VO2max refers to the highest rate at which oxygen can be taken up and consumed by the body during intense exercise. The "F.I.T.T." principle is an acronym for the four components for exercise prescription: frequency, intensity, time (length), and type of exercise.
Exercise intensity is arguably the most critical component of the exercise prescription model. Failure to meet minimal threshold values may result in lack of a training effect, while too high of an exercise intensity could lead to over-training and negatively impact adherence to an exercise program. The traditional reference standard for prescribing exercise intensity is expressed in terms of percentages of heart rate reserve (%HRR) or oxygen uptake reserve (%VO2R). This is considered the 'relative percent method'. The American College of Sports Medicine (ACSM) currently recommends an exercise intensity of 40-59% HRR/VO2R for improving and maintaining cardiorespiratory fitness. Nevertheless, despite a large evidence base supporting the ACSM relative percent concept recommendation for prescribing exercise intensity, there is concern that the approach consists of a very large range of acceptable percentages and fails to take into account individual metabolic responses to exercises. This study sought to compare the effectiveness of two exercise training programs for improving cardiorespiratory fitness: the ACE three-zone training model (i.e., threshold based training) versus the more common ACSM recommended relative percent concept (i.e., %HRR).
Apparently healthy, but sedentary men and women (n = 42) were randomized to a non-exercise control group or one of two exercise training groups. Exercise training was performed 30 min/day on 5 days/wk for 12wk according to one of two exercise intensity regimens: 1) a relative percent method was used in which intensity was prescribed according to percentages of heart rate reserve (HRR group), or 2) a threshold based method (ACE-3ZM) was used in which intensity was prescribed according to the first ventilatory threshold (VT1) and second ventilatory threshold (VT2).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Threshold based method | Experimental | Other: ExerciseExercise Week 1 Heart rate (HR) < first ventilatory threshold (VT1) 3 days 20 min/day Week 2 HR < VT1 4 days 25 min/day Week 3 HR < VT1 4 days 30 min/day Week 4 HR < VT1 5 days 30 min/day Week 5-6 HR ≥ VT1 to < second ventilatory threshold (VT2) 5 days 30 min/day Weeks 7-8 HR ≥ VT1 to < VT2 5 days 30 min/day Weeks 9-12 HR ≥ VT2 5 days 30 min/day |
| Relative percent method | Experimental | Other: ExerciseExercise Week 1 40-45% heart rate reserve 3 days 20 min/day Week 2 40-45% heart rate reserve 4 days 25 min/day Week 3 40-45% heart rate reserve 4 days 30 min/day Week 4 40-45% heart rate reserve 5 days 30 min/day Week 5-6 50-55% heart rate reserve 5 days 30 min/day Weeks 7-8 50-55% heart rate reserve 5 days 30min/day Weeks 9-12 60-65% heart rate reserve 5 days 30 min/day |
| Control | No intervention | –Non-exercise control group |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Participants were eligible for inclusion into the study if they were low-to-moderate risk as defined by the ACSM and sedentary.
- Participants were also eligible for inclusion into the study if they verbally agreed to continue previous dietary habits and not perform additional exercise beyond that required for the present study.
Key exclusion criteria (1 listed)
- Exclusionary criteria included evidence of cardiovascular pulmonary, and/or metabolic disease.
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 |
|---|---|---|
| ExerciseContinuous aerobic exercise prescribed according to two exercise intensity methods: threshold based method (i.e., ventilatory threshold) and relative percent method (i.e., heart rate reserve). | Other | Relative percent method, Threshold based method |
Primary outcome
Maximal oxygen uptake (VO2max) as a measure of cardiorespiratory fitness
Time frame: 12 weeks
Estimate of 10-year Cardiovascular Disease Risk
Time frame: 12 weeks
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 3 Feb 2015.
- Derived from this study: PubMed 26146564Wolpern AE, Burgos DJ, Janot JM, Dalleck LC. Is a threshold-based model a superior method to the relative percent concept for establishing individual exercise intensity? a randomized controlled trial. BMC Sports Sci Med Rehabil. 2015 Jul 4;7:16. doi: 10.1186/s13102-015-0011-z. eCollection 2015.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Exercise in people with Cardiovascular Disease, run by Western Colorado University.
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 2 inclusion and 1 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 3 Feb 2015. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Maximal oxygen uptake (VO2max) as a measure of cardiorespiratory fitness (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02351713, which also lists 1 linked publication.
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 3 Feb 2015.