NCT03568214

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?

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

June 26, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

June 26, 2018

Status Verified

June 1, 2018

Enrollment Period

12 months

First QC Date

May 30, 2018

Last Update Submit

June 19, 2018

Conditions

ExerciseMetabolic Syndrome

Keywords

Primary Prevention

Outcome Measures

Primary Outcomes (1)

  • Maximal oxygen uptake (VO2max)

    gas exchange data measured with indirect calorimetry

    12 weeks

Secondary Outcomes (5)

  • blood pressure

    12 weeks

  • fasting blood lipids and glucose

    12 weeks

  • waist circumference

    12 weeks

  • body composition

    12 weeks

  • weight

    12 weeks

Study Arms (3)

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

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)

Other: Exercise

Control

NO INTERVENTION

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

Interventions

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).

Individualized moderate + high-intensityStandardized moderate-intensity

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western State Colorado University

Gunnison, Colorado, 82123, United States

RECRUITING

MeSH Terms

Conditions

Motor ActivityMetabolic Syndrome

Interventions

Exercise

Condition Hierarchy (Ancestors)

BehaviorInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Lance Dalleck, PhD

    A/Professor and Institutional Officer

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lance C Dalleck, PhD

CONTACT

970-943-7132ldalleck@western.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 30, 2018

First Posted

June 26, 2018

Study Start

January 1, 2018

Primary Completion

December 31, 2018

Study Completion

March 31, 2019

Last Updated

June 26, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)