Cardiovascular DiseasesNCT03479177
Home-Based High Intensity Interval Training Intervention for Low Active Adults
A study testing High Intensity Interval Training in people with Cardiovascular Diseases, run by University of Minnesota at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- High Intensity Interval Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2018to 1 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 and older
- Exercising for 90 minutes or less each week
- Access to the Internet
Who cannot join
- 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.
Show all 9Show fewer
- Current or planned pregnancy
- Psychosis or current suicidal ideation
- Psychiatric hospitalization within the last six months
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota- Twin Cities
Minneapolis, Minnesota, 55455
About this study
Official title: 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).
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.
- Conditions
- Cardiovascular Diseases
- Being tested
- High Intensity Interval Training
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Interval TrainingBehavioural
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 group | Role | What they receive |
|---|---|---|
| High Intensity Interval Training | Experimental | 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. Receives: Behavioral: High Intensity Interval Training |
| Wait-List Control Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline to 12 weeks
Secondary outcomes (5)
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.
Measured: Change from Baseline to 12 weeks
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).
Measured: Change from Baseline to 12 weeks
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.
Measured: Change from Baseline to 12 weeks
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.
Measured: Change from Baseline to 12 weeks
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.
Measured: Change from Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start1 Jul 2018
- Primary completion1 Sep 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beth Lewis, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03479177
- Sponsor's protocol ID
- STUDY00001989
- Status last verified
- Oct 2019
- First submitted
- 29 Jan 2018
- Last updated
- 9 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers.
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Home-Based High Intensity Interval Training Intervention on Increasing Exercise Among Low Active Adults
- ClinicalTrials.gov ID
- NCT03479177
- Acronym / sponsor ID
- STUDY00001989
- Conditions
- Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 27 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Intensity Interval Training | Experimental | Behavioral: High Intensity Interval TrainingThe 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. |
| Wait-List Control Group | No intervention | –Participants in the wait-list control condition will have the option of receiving the exercise intervention program after completion of the final assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 and older
- Exercising for 90 minutes or less each week
- Access to the Internet
Key exclusion criteria (9 listed)
- A history of coronary heart disease (history of myocardial infarction, symptoms of angina)
- Orthopedic problems that would limit physical activity participation
- Diabetes
- Stroke
- Osteoarthritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Intensity Interval TrainingThe 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. | Behavioural | High Intensity Interval Training |
Primary outcome
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.
5 secondary outcomes
Biometrics
Time frame: Change from Baseline to 12 weeks
Social Support for Exercise Questionnaire
Time frame: Change from Baseline to 12 weeks
Physical Activity Self-efficacy Questionnaire
Time frame: Change from Baseline to 12 weeks
Physical Activity Enjoyment Scale (PACES)
Time frame: Change from Baseline to 12 weeks
Outcome Expectancies Questionnaire
Time frame: Change from Baseline to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2019.
- Derived from this study: PubMed 36809292Lewis 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.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beth Lewis, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Interval Training in people with Cardiovascular Diseases, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise minutes per week (time frame: Change from Baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03479177, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2019.