- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03479177
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
50
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 Locations
-
-
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
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 |
Intervention / Treatment |
---|---|
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.
|
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
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
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
Investigators
- 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)
July 1, 2018
Primary Completion (Actual)
September 1, 2019
Study Completion (Actual)
September 1, 2019
Study Registration Dates
First Submitted
January 29, 2018
First Submitted That Met QC Criteria
March 23, 2018
First Posted (Actual)
March 27, 2018
Study Record Updates
Last Update Posted (Actual)
October 9, 2019
Last Update Submitted That Met QC Criteria
October 8, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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