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

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ClinicalTrials.gov Identifier: NCT03357601
Recruitment Status : Not yet recruiting
First Posted : November 30, 2017
Last Update Posted : November 30, 2017
Sponsor:
Information provided by (Responsible Party):
Peter Lemon, Western University, Canada

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Physical Activity Fat Burn Behavioral: HIIT Behavioral: MCEET Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Each participant will be match-paired to either HIIT or MCEET group based on their time to complete a mile run. There will be rank from 1 to 40, where number one will be assigned randomly to one group while two goes to the other group. Then, number three goes to the second group and fourth is assigned to the first group. Alternating patterns will be continued thereafter.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of High Intensity Interval vs Moderate Continuous Endurance Exercise Training on Program Adherence
Estimated Study Start Date : January 3, 2018
Estimated Primary Completion Date : February 7, 2018
Estimated Study Completion Date : February 14, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. Endurance Capacity [ Time Frame: 5 weeks ]
    A mile run performance is an indication for a relative VO2 max.



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT03357601


Contacts
Contact: Peter Lemon, PhD 1-519-661-2111 ext 88139 plemon@uwo.ca
Contact: Minkee Kim 1-519-670-0920 mkim489@uwo.ca

Locations
Canada, Ontario
3M Centre, Room 2225 Not yet recruiting
London, Ontario, Canada, N6A5B9
Contact: School of Kinesiology    1-519-661-3092    kinug@uwo.ca   
Sponsors and Collaborators
Western University, Canada
Investigators
Principal Investigator: Peter Lemon, PhD Western University, Canada
  Study Documents (Full-Text)

Documents provided by Peter Lemon, Western University, Canada:
Informed Consent Form  [PDF] November 19, 2017


Additional Information:
Publications:
Responsible Party: Peter Lemon, Professor, Western University, Canada
ClinicalTrials.gov Identifier: NCT03357601     History of Changes
Other Study ID Numbers: 110476
First Posted: November 30, 2017    Key Record Dates
Last Update Posted: November 30, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Peter Lemon, Western University, Canada:
High Intensity Interval
Moderate Endurance Exercise
Fat Loss
Endurance Capacity