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Personalized Moderate Intensity Exercise Training Combined With High Intensity Interval

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ClinicalTrials.gov Identifier: NCT03568214
Recruitment Status : Recruiting
First Posted : June 25, 2018
Last Update Posted : June 25, 2018
Sponsor:
Collaborator:
Flinders University
Information provided by (Responsible Party):
Lance Dalleck, Western State Colorado University

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?

Condition or disease Intervention/treatment Phase
Exercise Metabolic Syndrome Other: Exercise Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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?
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Individualized moderate + high-intensity
  • 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
Other: Exercise
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).

Experimental: Standardized moderate-intensity
  • 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)
Other: Exercise
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).

No Intervention: Control
non-exercise control group testing at baseline and post-program (12 weeks)



Primary Outcome Measures :
  1. Maximal oxygen uptake (VO2max) [ Time Frame: 12 weeks ]
    gas exchange data measured with indirect calorimetry


Secondary Outcome Measures :
  1. blood pressure [ Time Frame: 12 weeks ]
    measured using a sphygmomanometer

  2. fasting blood lipids and glucose [ Time Frame: 12 weeks ]
    measured by analysis of a fingerstick blood sample using the Cholestech LDX System

  3. waist circumference [ Time Frame: 12 weeks ]
    measured using a cloth tape with a spring-loaded handle

  4. body composition [ Time Frame: 12 weeks ]
    measured via skinfold assessment

  5. weight [ Time Frame: 12 weeks ]
    measured with medical grade scale



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03568214


Contacts
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Contact: Lance C Dalleck, PhD 970-943-7132 ldalleck@western.edu

Locations
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United States, Colorado
Western State Colorado University Recruiting
Gunnison, Colorado, United States, 82123
Contact: Lance C Dalleck, PhD    970-943-7132    ldalleck@western.edu   
Sponsors and Collaborators
Western State Colorado University
Flinders University
Investigators
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Principal Investigator: Lance Dalleck, PhD A/Professor and Institutional Officer

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Responsible Party: Lance Dalleck, Associate Professor, Western State Colorado University
ClinicalTrials.gov Identifier: NCT03568214     History of Changes
Other Study ID Numbers: WesternSCU(3)
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lance Dalleck, Western State Colorado University:
Primary Prevention

Additional relevant MeSH terms:
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Metabolic Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases