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CompletedNCT03479177Updated Oct 9, 2019

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

An interventional study of High Intensity Interval Training in Cardiovascular Diseases, sponsored by University of Minnesota. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-09.

Sponsored by University of Minnesota · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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).

Read the 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.

02

Conditions studied

  • Cardiovascular Diseases
03

In context

Cardiovascular Diseases

5,025 studies on the registry are indexed under Cardiovascular Diseases; 930 are open to participants now.

This study's enrollment of 50 is below the median of 100 across 2,801 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

University of Minnesota is the lead sponsor of 1,210 studies on the registry; 195 are open to participants now.

Of its 133 completed or terminated interventional studies of FDA-regulated products, 92 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • 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

  • 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.

Interventions

  • BehavioralHigh 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.

06

What researchers measure

Primary outcomes

  1. Exercise minutes per week

    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.

    Time frame: Change from Baseline to 12 weeks

Secondary outcomes

  1. Biometrics

    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.

    Time frame: Change from Baseline to 12 weeks

  2. Social Support for Exercise Questionnaire

    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).

    Time frame: Change from Baseline to 12 weeks

  3. Physical Activity Self-efficacy Questionnaire

    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.

    Time frame: Change from Baseline to 12 weeks

  4. Physical Activity Enjoyment Scale (PACES)

    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.

    Time frame: Change from Baseline to 12 weeks

  5. Outcome Expectancies Questionnaire

    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.

    Time frame: Change from Baseline to 12 weeks

07

Study locations

1 site
  • University of Minnesota- Twin Cities
    Minneapolis, Minnesota 55455, United States
08

References and documents

Publications

  • Lewis BA, Schuver K, Dunsiger S. Evaluating the feasibility and efficacy of a home-based combined high intensity interval and moderate intensity training program for increasing physical activity among low-active adults: A randomized pilot trial. PLoS One. 2023 Feb 21;18(2):e0281985. doi: 10.1371/journal.pone.0281985. eCollection 2023. PubMed 36809292 ↗

Individual participant data

Plan to share: No — IPD will not be shared with other researchers.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2018 to primary completion in Sep 2019, 14 months.

Of 1,032 non-industry interventional studies with no phase under Cardiovascular Diseases, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's 14 months is below that.

Counting every sponsor, half of 1,148 studies reached it within 26 months; a quarter within 13 and three quarters within 49.

Cardiovascular Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 29, 2018
First posted
Mar 27, 2018
StartActual
Jul 1, 2018
Primary completionActual
Sep 1, 2019
CompletionActual
Sep 1, 2019
Last update
Oct 9, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 9, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03479177
Responsible party
Sponsor
First posted
Mar 27, 2018
Start date
Jul 1, 2018
Primary completion
Sep 1, 2019
Completion
Sep 1, 2019
Last update
Oct 9, 2019

Study contacts

Beth Lewis, PhD
principal investigator · University of Minnesota

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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