Home-Based High Intensity Interval Training Intervention for Low Active Adults

October 8, 2019 updated by: University of Minnesota

The Effect of a Home-Based High Intensity Interval Training Intervention on Increasing Exercise Among Low Active Adults

The purpose of this study is to examine the effect of a home-based high intensity interval training intervention on exercise among low active adults (defined as engaging in exercise 90 minutes or less per week). Participants will be randomly assigned to a HIIT-based intervention or a wait-list control each lasting 12 weeks (participants in the wait-list control condition will have the option of receiving the HIIT intervention following the 12 weeks).

Study Overview

Status

Status

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

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

The intervention will be a 12-week high intensity interval training workout that will consist of home-based exercise sessions prescribed by the exercise counselor. The exercise sessions will be based on exercises the participant can confidentially engage in (regular push-ups vs. knee push-ups vs. wall push-ups). The goal will be to engage in three exercise sessions per week. The participants will receive weekly telephone calls during the first month and bi-weekly calls during months 2 and 3. The exercise counselor will also engage in dialogue that will motivate the participant to exercise.

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 (Actual)

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.
50

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 Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota- Twin Cities

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 and older
  • Exercising for 90 minutes or less each week
  • Access to the Internet

Exclusion Criteria:

  • A history of coronary heart disease (history of myocardial infarction, symptoms of angina)
  • Orthopedic problems that would limit physical activity participation
  • Diabetes
  • Stroke
  • Osteoarthritis
  • Any other medical condition that may make physical activity unsafe or unwise.
  • Current or planned pregnancy
  • Psychosis or current suicidal ideation
  • Psychiatric hospitalization within the last six months

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

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
The exercise group will participate in a home and telephone-based program consisting of a 12-week high intensity interval training workout (HIIT). The home-based exercise sessions will be prescribed by the program exercise counselor, with a goal to exercise three times per week. The program will be tailored to meet specific fitness and strength needs of the participant. The participant will receive weekly telephone calls during the first month and bi-weekly calls during months 2 and 3. At 12 weeks, participants in both the exercise and wait-list control group will complete online questionnaires. The ActiGraph will be returned to the University of Minnesota research staff via a pre-paid postage envelope.
Behavioral: High Intensity Interval Training
The exercise sessions will be based on exercises the participant can confidentially engage in (regular push-ups vs. knee push-ups vs. wall push-ups). The goal will be to engage in three exercise sessions per week. The participants will receive weekly telephone calls during the first month and bi-weekly calls during months 2 and 3. The exercise counselor will also engage in dialogue that will motivate the participant to exercise.
No Intervention: Wait-List Control Group
Participants in the wait-list control condition will have the option of receiving the exercise intervention program after completion of the final assessment.

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
Exercise minutes per week
Time Frame: Change from Baseline to 12 weeks
Exercise minutes per week as assessed by an accelerometer for one week at baseline and 12 weeks. Higher reported minutes per week indicates a higher level of physical activity.
Change from Baseline to 12 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
Biometrics
Time Frame: Change from Baseline to 12 weeks
Body Mass Index will be calculated based on combining weight and height to report BMI as kg/m*2. The higher the number (level) of BMI, indicative of higher weight to height ratio.
Change from Baseline to 12 weeks
Social Support for Exercise Questionnaire
Time Frame: Change from Baseline to 12 weeks
Assesses the degree to which the individuals has friends and family who support their exercise. Participants rate how often family member or friend expresses social support for physical activity with scale (0=none, 4=very often). Overall total score range 0- 104 with subscales for family (0-52) and friends (0-52).
Change from Baseline to 12 weeks
Physical Activity Self-efficacy Questionnaire
Time Frame: Change from Baseline to 12 weeks
Assesses the amount of confidence the individual has to engage in exercise. Five questions, responses are on a scale from 1- 5 with participants indicating how confident they are on that scale of engaging in exercise in that situation (1=not at all confident, 5=extremely confident). Range of scores 5-25.
Change from Baseline to 12 weeks
Physical Activity Enjoyment Scale (PACES)
Time Frame: Change from Baseline to 12 weeks
Assesses the degree to which the individual enjoys exercise. The Physical Activity Enjoyment Scale is an 18-item scale that assesses enjoyment for physical activity by asking participants to rate "how you feel at the moment about the physical activity you have been doing" using a 7- point bipolar Likert scale, from 1 (I enjoy it) to 7 (I hate it). Eleven items were negatively worded and seven items were positively worded. After reverse scoring the 11negatively worded items, an overall enjoyment for physical activity score is determined by summing the items, with a range of 18-126 being possible. Higher scores indicate higher enjoyment.
Change from Baseline to 12 weeks
Outcome Expectancies Questionnaire
Time Frame: Change from Baseline to 12 weeks
Assesses what benefits the individual expects to gain from exercise. Responses on a scale from 1-5 (1=strongly disagree, 5=strongly agree), with participants indicating how strongly they agree to potential outcomes of exercise. Scores range from 9-45 with higher scores indicating greater outcome expectation.
Change from Baseline to 12 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.
University of Minnesota

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Beth Lewis, PhD, University of Minnesota

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 (Actual)

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.
July 1, 2018

Primary Completion (Actual)

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.
September 1, 2019

Study Completion (Actual)

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.
September 1, 2019

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).
January 29, 2018

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.
March 23, 2018

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.
March 27, 2018

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.
October 9, 2019

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.
October 8, 2019

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.
October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • STUDY00001989

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared with other researchers.

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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