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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03479177
Other study ID # STUDY00001989
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2018
Est. completion date September 1, 2019

Study information

Verified date October 2019
Source University of Minnesota - Clinical and Translational Science Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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). 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date September 1, 2019
Est. primary completion date September 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States University of Minnesota- Twin Cities Minneapolis Minnesota

Sponsors (1)

Lead Sponsor Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Change from Baseline to 12 weeks
Secondary 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. Change from Baseline to 12 weeks
Secondary 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). Change from Baseline to 12 weeks
Secondary 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. Change from Baseline to 12 weeks
Secondary 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. Change from Baseline to 12 weeks
Secondary 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. Change from Baseline to 12 weeks
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