Clinical Trials Logo

Clinical 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 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?


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT03568214
Study type Interventional
Source Western State Colorado University
Contact Lance C Dalleck, PhD
Phone 970-943-7132
Email ldalleck@western.edu
Status Recruiting
Phase N/A
Start date January 1, 2018
Completion date March 31, 2019

See also
  Status Clinical Trial Phase
Recruiting NCT04635202 - Effect of Elliptical Training on Metabolic Homeostasis in Metabolic Syndrome N/A
Completed NCT04053686 - An Intervention to Reduce Prolonged Sitting in Police Staff N/A
Completed NCT05343858 - Pilot Study to Evaluate the Effect of Two Microalgae Consumption on Metabolic Syndrome N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Recruiting NCT05040958 - Carotid Atherosclerotic Plaque Load and Neck Circumference
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Active, not recruiting NCT02500147 - Metformin for Ectopic Fat Deposition and Metabolic Markers in Polycystic Ovary Syndrome (PCOS) Phase 4
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Completed NCT03289897 - Non-invasive Rapid Assessment of NAFLD Using Magnetic Resonance Imaging With LiverMultiScan N/A
Recruiting NCT05956886 - Sleep Chatbot Intervention for Emerging Black/African American Adults N/A
Completed NCT06057896 - Effects of Combined Natural Molecules on Metabolic Syndrome in Menopausal Women
Active, not recruiting NCT03613740 - Effect of Fucoxanthin on the Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion Phase 2
Completed NCT04498455 - Study of a Prebiotic Supplement to Mitigate Excessive Weight Gain Among Physicians in Residency Phase 4
Completed NCT05688917 - Green Coffee Effect on Metabolic Syndrome N/A
Completed NCT04117802 - Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome N/A
Completed NCT03697382 - Effect of Daily Steps on Fat Metabolism N/A
Completed NCT03241121 - Study of Eating Patterns With a Smartphone App and the Effects of Time Restricted Feeding in the Metabolic Syndrome N/A
Completed NCT04509206 - Virtual Teaching Kitchen N/A
Completed NCT05124847 - TREating Pediatric Obesity N/A