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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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

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

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.
30

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.

Study Contact Backup

Study Locations

  • Canada
    • 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

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

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

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 (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.
Behavioral: Exercise Adherence
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.
Behavioral: Exercise Adherence
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.
Behavioral: Exercise Adherence
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

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
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

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
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

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.

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.
December 2, 2021

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.
January 1, 2022

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.
August 1, 2022

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).
August 16, 2021

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.
September 15, 2021

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.
September 27, 2021

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 26, 2021

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, 2021

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, 2021

More Information

Terms related to this study

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.
  • 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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