ExerciseNCT03568214
Personalized Moderate Intensity Exercise Training Combined With High Intensity Interval
A study testing Exercise in people with Exercise and Metabolic Syndrome, run by Western Colorado University at 1 site in United States.
Trial summary
The purpose of this study will be to determine if personalized moderate intensity exercise training combined with high intensity interval training is more effective at improving training responsiveness than moderate intensity exercise training alone? This question will be addressed holistically be creating a composite… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise, Metabolic Syndrome
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2018to 31 Mar 2019
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Considered low to moderate risk for cardiovascular disease based on the American College of Sports medicine guidelines
- Currently sedentary (participating in less than 30 minutes of moderate intensity physical activity on at least three days a week)
- Resided at an altitude of 2300 meters for at least the last 6 months
Who cannot join
- Any known sign, symptom, or diagnosed cardiovascular, pulmonary, metabolic, or similar disease
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Western State Colorado University
Gunnison, Colorado, 82123
Lance C Dalleck, PhD, 970-943-7132, ldalleck@western.edu
About this study
Official title: Is Personalized Moderate Intensity Exercise Training Combined With High Intensity Interval Training More Effective at Improving Training Responsiveness When Compared to Moderate Intensity Exercise Training Alone?
The purpose of this study will be to determine if personalized moderate intensity exercise training combined with high intensity interval training is more effective at improving training responsiveness than moderate intensity exercise training alone? This question will be addressed holistically be creating a composite score to assess training responsiveness. Additionally, individualized biological variability will be calculated in order to quantify training responsiveness using a personalized criterion. It is hypothesized that personalized moderate intensity exercise training combined with high intensity interval training will be more effective at improving comprehensive training responsiveness when compared to moderate intensity exercise training alone?
Read the detailed description
It is well established that regular physical activity and cardiorespiratory fitness (CRF) training confers numerous health benefits and that a low level of CRF is a risk factor for coronary heart disease and cardiovascular disease (CVD) mortality. It is generally accepted that CRF can be improved with the implementation of a regular aerobic exercise training program following standardized guidelines. However, it has also been shown that not all individuals respond positively to such exercise, indeed there is considerable individual variability in training adaptations including so-termed 'non-responders' and, in some instances, 'adverse responders'. This variability in training responsiveness is not well understood and may be attributable to various factors including absence of a set definition in the literature for incidence of response and lack of an individualized approach to the exercise prescription.
It has been purported that a more individualized approach to the exercise prescription may enhance training efficacy and limit training unresponsiveness. For instance, it has been acknowledged as far back as the late 1970s that utilizing a relative percent method (i.e., % heart rate reserve [HRR]) to establish exercise intensity fails to account for individual metabolic responses to exercise. Nevertheless, the relative percent concept remains the gold standard recommendation for exercise intensity. It is both plausible and practical to think that an intensity set based on an individual's threshold measurement (i.e. ventilatory threshold) will not only encourage more positive physiological adaptations, but may account for some of the variability in training responsiveness by taking into consideration individual metabolic differences.
Additionally, high intensity interval training (HIIT) has emerged as a potential time efficient strategy for health promotion. Current recommended guidelines of 150 minutes of moderate physical activity per week is reduced by half to 75 minutes if the week's activity is done at a vigorous intensity. It has been demonstrated that HIIT, when compared to moderate intensity continuous training (MICT), has resulted in equal or superior improvements in VO2max, insulin action and sensitivity, endothelial function, systolic blood pressure, hip and waist circumference and lipid oxidation. The American College of Sports Medicine suggests considering incorporating interval training after a period of initial conditioning (typically 2-3 months) intermittently to avoid excessive orthopedic stress. Additionally, HIIT may require initial supervision in untrained and high risk individuals, and may transiently increase the risk of cardiac events in people with underlying undiagnosed CVD. Therefore, it seems pragmatic and consistent with current recommendations to combine the two types of training to achieve the greatest positive changes in cardiovascular and metabolic health.
It has been common practice to quantify training responsiveness based on absolute changes, but this method fails to take into consideration biological variability (normal day-to-day biological fluctuations) and measurement error of the equipment. Consequently, currently there is not a clear consensus on best practice to prescribe a customized exercise intervention that takes into consideration individual characteristics and diagnostic information. Furthermore, it may be that a personalized definition of biological variability is warranted. This is congruent with the line of reasoning that a more individualized approach to the exercise prescription may enhance training efficacy and limit training unresponsiveness. Simply put - if we are looking at exercise prescription (i.e., the front end) from an individualized perspective, it would also make sense to look at training responsiveness (i.e., the back end) from an individualized perspective as well.
Furthermore, classification and interpretation of training responsiveness may require a holistic view that integrates all exercise training outcomes. For example, in a recent study an adverse response in one single measure rarely resulted in higher overall risk of CVD. In fact, 10-year CVD risk increased in only three individuals (out of 332 individuals) as highlighted in this investigation. This finding has practical implications suggesting that although some individuals may have adverse or nonresponse cardiometabolic responses to exercise training, this may not always result in increased CVD risk and exercise may benefit these participants in different ways, such as improved cardiorespiratory fitness. Indeed, in the previously mentioned study, more than 40% (9/22) of 'adverse responders' concurrently increased cardiorespiratory fitness levels by 10% or more. Higher levels of cardiorespiratory fitness have been offered as an antidote toward other risk factors. Moreover, the literature suggests a 15% reduction in mortality for a 10% improvement in cardiorespiratory fitness. Taken together, it may be unintentionally misleading to categorize someone as an "adverse responder or non-responder to exercise" based on a single cardiometabolic factor when it is well known that regular exercise training confers a myriad of benefits. Clearly, the overall topic of training responsiveness to exercise warrants much additional study.
45 low-to-moderate risk, sedentary men and women will be recruited and randomized to one of the following arms:
- MICT + HIIT exercise program (N = 15)
- MICT exercise program (N = 15)
- non-exercise control group (N = 15)
- Conditions
- Exercise, Metabolic Syndrome
- Being tested
- Exercise
- Keywords
- Primary Prevention
- Medical subject headings
- Motor Activity, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
The MICT will be prescribed according to two exercise intensity methods: individualized (i.e., VT1 and VT2) and standardized (i.e., HRR). The HIIT will be prescribed based on individual fitness (i.e., VO2max).
| Study group | Role | What they receive |
|---|---|---|
| Individualized moderate + high-intensity | Experimental | * 12 weeks of moderate-intensity continuous training (MICT) combined with high-intensity interval training (HIIT)
* 4 days per week of MICT for 50 minutes per session
* 1 day per week of HIIT for 35 minutes per session
* Exercise intensity for MICT will be established according to ventilatory thresholds one and two (VT1 and VT2)
* The HIIT protocol will consist of eight, 60 second intervals at 100% maximal oxygen uptake (VO2max), separated by 150 seconds active recovery Receives: Other: Exercise |
| Standardized moderate-intensity | Experimental | * 12 weeks of MICT
* 5 days per week of MICT for 50 minutes per session
* Exercise intensity for MICT will be established according to 40-65% heart rate reserve (HRR) Receives: Other: Exercise |
| Control | No intervention | non-exercise control group testing at baseline and post-program (12 weeks) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal oxygen uptake (VO2max)
gas exchange data measured with indirect calorimetry
Measured: 12 weeks
Secondary outcomes (5)
blood pressure
measured using a sphygmomanometer
Measured: 12 weeks
fasting blood lipids and glucose
measured by analysis of a fingerstick blood sample using the Cholestech LDX System
Measured: 12 weeks
waist circumference
measured using a cloth tape with a spring-loaded handle
Measured: 12 weeks
body composition
measured via skinfold assessment
Measured: 12 weeks
weight
measured with medical grade scale
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 posted26 Jun 2018
- Study start1 Jan 2018
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western Colorado University
- Sponsor type
- University, hospital or other
- Collaborators
- Flinders University
- Responsible party
- Principal investigator, Lance Dalleck, Western Colorado University
- Investigators
- Lance Dalleck, PhD, Principal investigator, A/Professor and Institutional Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03568214
- Sponsor's protocol ID
- WesternSCU(3)
- Status last verified
- Jun 2018
- First submitted
- 30 May 2018
- Last updated
- 26 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Personalized Moderate Intensity Exercise Training Combined With High Intensity Interval Training More Effective at Improving Training Responsiveness When Compared to Moderate Intensity Exercise Training Alone?
- ClinicalTrials.gov ID
- NCT03568214
- Acronym / sponsor ID
- WesternSCU(3)
- Conditions
- Exercise, Metabolic Syndrome
- Keywords
- Primary Prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Western Colorado UniversityUniversity, hospital or other
- Collaborators
- Flinders University
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Mar 2019 (estimated)
- First posted
- 26 Jun 2018 (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.
The purpose of this study will be to determine if personalized moderate intensity exercise training combined with high intensity interval training is more effective at improving training responsiveness than moderate intensity exercise training alone? This question will be addressed holistically be creating a composite score to assess training responsiveness. Additionally, individualized biological variability will be calculated in order to quantify training responsiveness using a personalized criterion. It is hypothesized that personalized moderate intensity exercise training combined with high intensity interval training will be more effective at improving comprehensive training responsiveness when compared to moderate intensity exercise training alone?
Detailed description
It is well established that regular physical activity and cardiorespiratory fitness (CRF) training confers numerous health benefits and that a low level of CRF is a risk factor for coronary heart disease and cardiovascular disease (CVD) mortality. It is generally accepted that CRF can be improved with the implementation of a regular aerobic exercise training program following standardized guidelines. However, it has also been shown that not all individuals respond positively to such exercise, indeed there is considerable individual variability in training adaptations including so-termed 'non-responders' and, in some instances, 'adverse responders'. This variability in training responsiveness is not well understood and may be attributable to various factors including absence of a set definition in the literature for incidence of response and lack of an individualized approach to the exercise prescription.
It has been purported that a more individualized approach to the exercise prescription may enhance training efficacy and limit training unresponsiveness. For instance, it has been acknowledged as far back as the late 1970s that utilizing a relative percent method (i.e., % heart rate reserve [HRR]) to establish exercise intensity fails to account for individual metabolic responses to exercise. Nevertheless, the relative percent concept remains the gold standard recommendation for exercise intensity. It is both plausible and practical to think that an intensity set based on an individual's threshold measurement (i.e. ventilatory threshold) will not only encourage more positive physiological adaptations, but may account for some of the variability in training responsiveness by taking into consideration individual metabolic differences.
Additionally, high intensity interval training (HIIT) has emerged as a potential time efficient strategy for health promotion. Current recommended guidelines of 150 minutes of moderate physical activity per week is reduced by half to 75 minutes if the week's activity is done at a vigorous intensity. It has been demonstrated that HIIT, when compared to moderate intensity continuous training (MICT), has resulted in equal or superior improvements in VO2max, insulin action and sensitivity, endothelial function, systolic blood pressure, hip and waist circumference and lipid oxidation. The American College of Sports Medicine suggests considering incorporating interval training after a period of initial conditioning (typically 2-3 months) intermittently to avoid excessive orthopedic stress. Additionally, HIIT may require initial supervision in untrained and high risk individuals, and may transiently increase the risk of cardiac events in people with underlying undiagnosed CVD. Therefore, it seems pragmatic and consistent with current recommendations to combine the two types of training to achieve the greatest positive changes in cardiovascular and metabolic health.
It has been common practice to quantify training responsiveness based on absolute changes, but this method fails to take into consideration biological variability (normal day-to-day biological fluctuations) and measurement error of the equipment. Consequently, currently there is not a clear consensus on best practice to prescribe a customized exercise intervention that takes into consideration individual characteristics and diagnostic information. Furthermore, it may be that a personalized definition of biological variability is warranted. This is congruent with the line of reasoning that a more individualized approach to the exercise prescription may enhance training efficacy and limit training unresponsiveness. Simply put - if we are looking at exercise prescription (i.e., the front end) from an individualized perspective, it would also make sense to look at training responsiveness (i.e., the back end) from an individualized perspective as well.
Furthermore, classification and interpretation of training responsiveness may require a holistic view that integrates all exercise training outcomes. For example, in a recent study an adverse response in one single measure rarely resulted in higher overall risk of CVD. In fact, 10-year CVD risk increased in only three individuals (out of 332 individuals) as highlighted in this investigation. This finding has practical implications suggesting that although some individuals may have adverse or nonresponse cardiometabolic responses to exercise training, this may not always result in increased CVD risk and exercise may benefit these participants in different ways, such as improved cardiorespiratory fitness. Indeed, in the previously mentioned study, more than 40% (9/22) of 'adverse responders' concurrently increased cardiorespiratory fitness levels by 10% or more. Higher levels of cardiorespiratory fitness have been offered as an antidote toward other risk factors. Moreover, the literature suggests a 15% reduction in mortality for a 10% improvement in cardiorespiratory fitness. Taken together, it may be unintentionally misleading to categorize someone as an "adverse responder or non-responder to exercise" based on a single cardiometabolic factor when it is well known that regular exercise training confers a myriad of benefits. Clearly, the overall topic of training responsiveness to exercise warrants much additional study.
45 low-to-moderate risk, sedentary men and women will be recruited and randomized to one of the following arms:
- MICT + HIIT exercise program (N = 15)
- MICT exercise program (N = 15)
- non-exercise control group (N = 15)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Individualized moderate + high-intensity | Experimental | Other: Exercise* 12 weeks of moderate-intensity continuous training (MICT) combined with high-intensity interval training (HIIT) * 4 days per week of MICT for 50 minutes per session * 1 day per week of HIIT for 35 minutes per session * Exercise intensity for MICT will be established according to ventilatory thresholds one and two (VT1 and VT2) * The HIIT protocol will consist of eight, 60 second intervals at 100% maximal oxygen uptake (VO2max), separated by 150 seconds active recovery |
| Standardized moderate-intensity | Experimental | Other: Exercise* 12 weeks of MICT * 5 days per week of MICT for 50 minutes per session * Exercise intensity for MICT will be established according to 40-65% heart rate reserve (HRR) |
| Control | No intervention | –non-exercise control group testing at baseline and post-program (12 weeks) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Considered low to moderate risk for cardiovascular disease based on the American College of Sports medicine guidelines
- Currently sedentary (participating in less than 30 minutes of moderate intensity physical activity on at least three days a week)
- Resided at an altitude of 2300 meters for at least the last 6 months
Key exclusion criteria (1 listed)
- Any known sign, symptom, or diagnosed cardiovascular, pulmonary, metabolic, or similar 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 |
|---|---|---|
| ExerciseThe MICT will be prescribed according to two exercise intensity methods: individualized (i.e., VT1 and VT2) and standardized (i.e., HRR). The HIIT will be prescribed based on individual fitness (i.e., VO2max). | Other | Individualized moderate + high-intensity, Standardized moderate-intensity |
Primary outcome
Maximal oxygen uptake (VO2max)
Time frame: 12 weeks
gas exchange data measured with indirect calorimetry
5 secondary outcomes
blood pressure
Time frame: 12 weeks
fasting blood lipids and glucose
Time frame: 12 weeks
waist circumference
Time frame: 12 weeks
body composition
Time frame: 12 weeks
weight
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
- Individual participant dataSharing planned: No
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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.
Lance Dalleck, PhD principal investigator
A/Professor and Institutional Officer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Exercise and Metabolic Syndrome, run by Western Colorado University at 1 site in United States.
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 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: status not confirmed, as of the sponsor's last update on 26 Jun 2018. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lance C Dalleck, PhD (970-943-7132, ldalleck@western.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal oxygen uptake (VO2max) (time frame: 12 weeks). 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 26 Jun 2018; AzTrials last refreshed its copy on 30 Oct 2026.