- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05057416
The Effect of Exercise Intensity on Adherence
November 23, 2021 updated by: Peter Lemon, Western University, Canada
This study aims to advance the knowledge of a novel strategy of exercise to help people achieve the health benefits of exercise in less commitment time.
As opposed to the traditionally recommended long periods (60 min) of moderate intensity exercise, this study will examine the effects of two exercise programs which consist of different intensities and repeated bouts of short intense exercise followed by rest periods.
By incorporating short intense bouts of exercise, it may be possible that individuals enjoy this strategy of exercising more, which may influence them to continue to train in this way, increase their exercise levels in daily life and achieve exercise-related health benefits.
Overall healthy women will be divided into a novel sprint interval training group or a high intensity interval training group or a traditional moderate intensity continuous training group.
To evaluate the success of each training approach, a health-related quality of life questionnaire, one mile run test, weight, strength test and adherence to study requirements will be assessed over a 6-week period.
The investigators hypothesize that the sprint interval training group will experience greatest strength measurements, will lose most body fat, have the greatest exercise benefits and will enjoy the novel training program more and will therefore adhere to the program more than the moderate continuous training group.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Since the majority of the population is inactive, this study is being done to develop a better strategy that might encourage people to exercise more and improve their health.
The current physical activity guidelines suggest that adults aged 18-64 should perform at least 150 minutes of moderate- to vigorous-intensity aerobic physical activity per week .
However, 84% of the Canadian population is insufficiently active.
The large percentage of inactive individuals may be due to the daunting expectation that individuals must exercise for long periods of time to achieve health benefits, and many individuals report not having enough time.
However, studies have shown that exercising for short, repeated bouts of intense exercise resulted in improved cardiometabolic health to the same extent as traditional endurance training, despite lower exercise volume.
One study found that the prescription for a higher frequency of exercise significantly increased the accumulation of exercise without a negative effect on adherence.
Further, in another study, participants who performed short intense bouts of physical activity have shown greater adherence than participants who were performing traditional exercise, working at a moderate intensity for a prolonged exercise period (89% and 71%, respectively).
None of the studies mentioned above examined time matched exercise groups and included varying intensities of exercise, and collected data through virtual means, mimicking the natural environment of participants.
The investigators believe that the proposed study will address these concerns and therefore advance the knowledge of sprint interval training.
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- 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
- Name: Magdalena Helbin, BSc
- Phone Number: 16476241276
- Email: magdalena.helbin@gmail.com
Study Contact Backup
- Name: Peter Lemon, PHD
- Email: plemon@uwo.ca
Study Locations
-
-
Ontario
-
London, Ontario, Canada, N6A3K7
- Exercise Nutrition Laboratory, Western University
-
London, Ontario, Canada, N6A 3K7
- Exercise Nutrition Laboratory (Western University)
-
-
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
Ages Eligible for Study
16 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Female
- Participants must be between 20-49 years old
- Sedentary- completing less than 1 hour per week of leisure time physical activity over the prior 12 months and/or not meeting the CSEP guidelines of 150 minutes of moderate to vigorous physical activity per week
- Generally healthy males and females, no racial or gender bias.
Exclusion Criteria:
- Male
- Diagnosis of diabetes
- Taking glucose lowering medication
- Uncontrolled hypertension blood pressure >160/90
- History of heart disease
- Previous myocardial infarction or stroke
- Contraindications of exercise
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: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: High Intensity Interval Training (HIIT) Protocol
Participants in the HIIT group will start with a 2.5-minute warm-up at about 30% VO2 max.
The participants will then complete 3 running bouts at 80-90% VO2 max.
Each running bout will be separated by 2 minutes of active rest where the participants will walk at 50% VO2 max.
The total exercise time of this protocol will be 15 minutes.
Finally, the participants will finish with a 2.5 min cool-down where they will walk at a light intensity of 30% VO2 max, for a total exercise duration of 20 minutes.
|
Our current study will compare three exercise groups which will all vary in intensity.
Participants will be randomly assigned to one of the three groups.
Two groups will be assigned to high intensity bouts of exercise with an active rest between, and one group will perform moderate intensity continuous training without resting.
All groups will exercise for 20 minutes.
Exercise adherence and it will be measured by a self-report online Google Document.
|
|
Experimental: Sprint Interval Training (SIT) Protocol
Participants in the Sprint Interval Training group will perform a 2.5-minute warm up at a VO2 max of 30%.
Next, the participants will perform 6 all-out sprints at 150-200% of VO2 max, separated by 2-minute active rests at 50% VO2 max.
The total exercise time of the SIT protocol is about 14 minutes.
Finally, the participants will perform a walking cool-down of 3.5 minutes at 30% VO2 max, for a total exercise duration of 20 minutes.
|
Our current study will compare three exercise groups which will all vary in intensity.
Participants will be randomly assigned to one of the three groups.
Two groups will be assigned to high intensity bouts of exercise with an active rest between, and one group will perform moderate intensity continuous training without resting.
All groups will exercise for 20 minutes.
Exercise adherence and it will be measured by a self-report online Google Document.
|
|
Experimental: Moderate Intensity Continuous Training (MICT)Protocol
Participants in the Moderate Intensity Continuous Training group will first be warming up for 2.5 minutes at a VO2 max of 30%.
After the warm up, participants will be running for 15 minutes at 45-60% of VO2 max.
Finally, the participants will perform a 2.5-minute cool-down at 30% VO2 max, for a total exercise duration of 20 minutes.
|
Our current study will compare three exercise groups which will all vary in intensity.
Participants will be randomly assigned to one of the three groups.
Two groups will be assigned to high intensity bouts of exercise with an active rest between, and one group will perform moderate intensity continuous training without resting.
All groups will exercise for 20 minutes.
Exercise adherence and it will be measured by a self-report online Google Document.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical Activity Enjoyment
Time Frame: 8 weeks
|
The enjoyment that participants experienced during the assigned intensity of exercise measured by the Physical Activity Enjoyment Scale (PAES).
|
8 weeks
|
|
Adherence to Exercise
Time Frame: 8 weeks
|
Participants will report whether or not they have continued with the plan throughout the study duration through a weekly exercise diary.
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Exercise endurance
Time Frame: 8 weeks
|
Participant cardiovascular endurance will be measured through a one-mile run test.
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
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)
December 2, 2021
Primary Completion (Anticipated)
January 1, 2022
Study Completion (Anticipated)
August 1, 2022
Study Registration Dates
First Submitted
August 16, 2021
First Submitted That Met QC Criteria
September 15, 2021
First Posted (Actual)
September 27, 2021
Study Record Updates
Last Update Posted (Actual)
November 26, 2021
Last Update Submitted That Met QC Criteria
November 23, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 119244
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Plan to share IPD data in journals.
IPD Sharing Time Frame
September 2022
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
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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