High Intensity Interval Training vs Moderate Continuous Endurance Exercise Training on Program Adherence

November 23, 2017 updated by: Peter Lemon, Western University, Canada

The Effect of High Intensity Interval vs Moderate Continuous Endurance Exercise Training on Program Adherence

This study examines whether high intensity interval training (HIIT) or moderate, continuous endurance exercise training (MCEET) results in greater program adherence when matched for session time. Body composition and endurance capacity will also be measured to identify any significant changes among two exercise groups. It is hypothesized that HIIT will result in greater program adherence as well as greater improvements in body composition and endurance capacity. Both exercise groups will complete 20 minutes sessions (which include exercise) three times per week for five week. The first week will be supervised by study investigators while the remainder of the study will be unsupervised in order to examine how free-living individuals adhere to two exercise programs. There will be no attempt to restrict food intake during the exercise intervention. Body composition will be measured by densitometry [body mass/body volume] using a BodPod. Endurance capacity will be assessed using a mile run. Two validated questionnaires [Physical activity enjoyment scale and Exercise adherence ratings scale] as well as heart rate data (recorded before, during and after each training sessions) will be used to confirm exercise adherence. These data may help us determine the optimal type of exercise program to maintain healthy body composition.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Upon completing informed consent, all the eligible participants will have their body composition measured at the Exercise Nutrition Research Laboratory, Western University, using non-invasive air displacement plethysmography (BodPod). This requires participants to sit in a chamber while space [volume] their bodies take up is assessed. This along with their body mass allows body density [d=m/v] and body composition to be determined pre and post the 5-week exercise intervention. Upon completing the body composition measurements, participants will have their endurance capacity assessed by performing a timed one-mile run (which will be used as an index of their endurance capacity). Participants will be advised to dress appropriately for physical activity including proper footwear.

Each participant will be matched to either HIIT or MCEET group based on their one-mile run time. The HIIT group will perform six, 20-second bouts of high-intensity interval exercise separated by 2 minutes of active recovery (walking) while the MCEET group will perform 14 minutes of continuous endurance exercise at 70% of Maximum Heart Rate (MHR). Both exercise protocols will include 3 minutes of warm up and cool down at a 30% MHR, for a total of 20 minutes for each treatment. The first week of the exercise intervention will consist of one-on-one supervised treadmill training, three times per week in the lab. From week two to five, participants will follow the same exercise program on their own at their preferred gym three times per week in order to examine free-living individuals adhere to two exercise programs.

All participants will log their heart rate before, during, and immediately after each training session using a free heart rate monitor mobile App to ensure safety and achievement of their targeted heart rate. Further, they will complete two validated questionnaires [physical activity enjoyment scale and exercise adherence rating scale] as well ratings of perceived exertion scale after the 6th, 9th and 15th session. Finally, no attempt will be made to modify the participants daily diet, but a 3-day food log will be collected to assess food intake.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Peter Lemon, PhD
  • Phone Number: 88139 1-519-661-2111
  • Email: plemon@uwo.ca

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A5B9
        • 3M Centre, Room 2225

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy
  • 19-35 years old
  • Engage in physical activity less than three times per week
  • Must have access to the gym
  • Must have smartphones (such as Android, Cat phone, Google Nexus, Samsung Galaxy, iPhone, Microsoft Lumia, myTouch or Phablets)
  • Must have access to Apps (such as MyFitnessPal, Rise Up, Calorific, My Diet Coach, Yazio, On The Regimen, See How You Eat, Lost It, MyNetDiary or MyPlate)
  • Must be able to run a mile

Exclusion Criteria:

  • Diabetic
  • Pregnant
  • History of fainting
  • Low and high blood pressure
  • Heart disease
  • Migraines
  • Experience with heartburn
  • Smokers
  • Respiratory diseases
  • Engage in physical activity more than two times per week
  • Answering YES to any questions from page 1 of GAQ

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: High Intensity Interval Training
six 20 second bouts of high intensity interval exercise (HIIT) separated by 2 minutes of active recovery with 3 minutes and warm up and cool down on the treadmill, three times per week for five weeks
Behavioral: HIIT
The participant will perform HIIT where they will warm up for 3 minutes at 30% maximum heart rate (MHR), followed by 20 seconds of high intensity interval exercise at an all out intensity separated by 2 minutes of active recovery at 30% MHR. The interval will be repeated six times. Once completing all six intervals, participants will cool down for 3 minutes. This training program will be performed three times per week for five weeks.
EXPERIMENTAL: MCEET
14 minutes of Moderate Endurance Training with 3 minutes and warm up and cool down on the treadmill, three times per week for five weeks
Behavioral: MCEET
The participant will perform MCEET, where they will warm up for 3 minutes at 30% maximum heart rate (MHR), followed by 14 minutes of moderate, continuous endurance exercise at 70% MHR. Participants will cool down for 3 minutes. This training program will be performed three times per week for five weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Program Adherence
Time Frame: 5 weeks
Physical Activity Enjoyment Scale assess levels of exercise enjoyment based on 18 questions on a 1 to 7 Likert Scale
5 weeks
Program Adherence
Time Frame: 5 weeks
Exercise Adherence Rating Scale measures adherence to prescribed exercise program based on 6 questions on a 0 to 4 Likert Scale
5 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body Composition
Time Frame: 5 weeks
A whole body densitometry (BodPod) measures body mass, fat mass and non-fat mass to determine body density which then gives body composition
5 weeks
Endurance Capacity
Time Frame: 5 weeks
A mile run performance is an indication for a relative VO2 max.
5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Western University, Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 3, 2018

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 7, 2018

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 14, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 17, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 23, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 30, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 30, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 23, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 110476

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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