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Personalized Moderate Intensity Exercise Training Combined With High Intensity Interval

Primary Purpose

Exercise, Metabolic Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Sponsored by
Western Colorado University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Exercise focused on measuring Primary Prevention

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Any known sign, symptom, or diagnosed cardiovascular, pulmonary, metabolic, or similar disease

Sites / Locations

  • Western State Colorado UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Individualized moderate + high-intensity

Standardized moderate-intensity

Control

Arm Description

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

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)

non-exercise control group testing at baseline and post-program (12 weeks)

Outcomes

Primary Outcome Measures

Maximal oxygen uptake (VO2max)
gas exchange data measured with indirect calorimetry

Secondary Outcome Measures

blood pressure
measured using a sphygmomanometer
fasting blood lipids and glucose
measured by analysis of a fingerstick blood sample using the Cholestech LDX System
waist circumference
measured using a cloth tape with a spring-loaded handle
body composition
measured via skinfold assessment
weight
measured with medical grade scale

Full Information

First Posted
May 30, 2018
Last Updated
June 19, 2018
Sponsor
Western Colorado University
Collaborators
Flinders University
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1. Study Identification

Unique Protocol Identification Number
NCT03568214
Brief Title
Personalized Moderate Intensity Exercise Training Combined With High Intensity Interval
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?
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
March 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western Colorado University
Collaborators
Flinders University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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?
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise, Metabolic Syndrome
Keywords
Primary Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Individualized moderate + high-intensity
Arm Type
Experimental
Arm Description
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
Arm Title
Standardized moderate-intensity
Arm Type
Experimental
Arm Description
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)
Arm Title
Control
Arm Type
No Intervention
Arm Description
non-exercise control group testing at baseline and post-program (12 weeks)
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
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).
Primary Outcome Measure Information:
Title
Maximal oxygen uptake (VO2max)
Description
gas exchange data measured with indirect calorimetry
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
blood pressure
Description
measured using a sphygmomanometer
Time Frame
12 weeks
Title
fasting blood lipids and glucose
Description
measured by analysis of a fingerstick blood sample using the Cholestech LDX System
Time Frame
12 weeks
Title
waist circumference
Description
measured using a cloth tape with a spring-loaded handle
Time Frame
12 weeks
Title
body composition
Description
measured via skinfold assessment
Time Frame
12 weeks
Title
weight
Description
measured with medical grade scale
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Any known sign, symptom, or diagnosed cardiovascular, pulmonary, metabolic, or similar disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lance C Dalleck, PhD
Phone
970-943-7132
Email
ldalleck@western.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lance Dalleck, PhD
Organizational Affiliation
A/Professor and Institutional Officer
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western State Colorado University
City
Gunnison
State/Province
Colorado
ZIP/Postal Code
82123
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lance C Dalleck, PhD
Phone
970-943-7132
Email
ldalleck@western.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Personalized Moderate Intensity Exercise Training Combined With High Intensity Interval

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