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Exercise, Activity and Smoking in Young Adults (EASY-A)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02527876
Recruitment Status : Withdrawn (Researcher left University)
First Posted : August 19, 2015
Last Update Posted : January 24, 2018
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Tracking Information
First Submitted Date  ICMJE August 5, 2015
First Posted Date  ICMJE August 19, 2015
Last Update Posted Date January 24, 2018
Study Start Date  ICMJE August 2015
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 17, 2015)
Number of Participants With Increase in Physical Activity as assessed by FitBit [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exercise, Activity and Smoking in Young Adults
Official Title  ICMJE Exercise to Promote Quit Attempts in Young Adults
Brief Summary The purpose of this study is to evaluate how physical activity levels change in young adults when they start a specific exercise program.
Detailed Description The purpose of this study is to evaluate how physical activity levels change in young adults when they start a specific exercise program. Physical activity levels will be monitored daily via a FitBit Flex. Outcome measures include number of minutes of activity per day and distance traveled per day.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Exercise, Delayed Control
Intervention  ICMJE
  • Behavioral: High Intensity Interval Training
    High Intensity Interval Training
    Other Name: FitBit Flex
  • Behavioral: Moderate Intensity
    Moderate Intensity Training
  • Behavioral: Delayed Control
    Delayed Control
  • Device: FitBit Flex
    Use to measure increase in Physical Activity
Study Arms  ICMJE
  • Experimental: High Intensity Interval Training/FitBit Flex
    Meet with personal trainer once per week for 20-minute exercise session
    Interventions:
    • Behavioral: High Intensity Interval Training
    • Device: FitBit Flex
  • Experimental: Moderate Intensity/FitBit Flex
    Meet with personal trainer once per week for 30-minute exercise session and exercise two times a week outside of personal trainer
    Interventions:
    • Behavioral: Moderate Intensity
    • Device: FitBit Flex
  • Placebo Comparator: Delayed Control/FtBit Flex
    No exercise offered
    Interventions:
    • Behavioral: Delayed Control
    • Device: FitBit Flex
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: January 22, 2018)
0
Original Estimated Enrollment  ICMJE
 (submitted: August 17, 2015)
60
Actual Study Completion Date  ICMJE October 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18-40 years old,
  • stable physical/mental health,
  • current smoker
  • currently minimally active,
  • ambulatory,
  • interested in increasing their physical activity,
  • willingness to attend weekly exercise intervention sessions at a SNAP Fitness location within 10 miles of the University of Minnesota campus,
  • the ability to comply with the study protocol and provide informed consent

Exclusion Criteria:

  • Contraindications to increasing physical activity including, but not limited to,
  • abnormal electrocardiogram or V02 test results,
  • high blood pressure (defined as systolic blood pressure over 165 or diastolic blood pressure over 100),
  • heart attack, acute (2 days) cardiac event or stroke in preceding six months,
  • unstable angina,
  • uncontrolled dysrhythmias causing hemodynamic compromise,
  • symptomatic severe aortic stenosis,
  • uncontrolled symptomatic heart failure,
  • acute pulmonary embolism or pulmonary infarction,
  • acute myocarditis or
  • pericarditis,
  • dissecting aneurism,
  • acute systemic infection and
  • unstable pulmonary or cardiovascular conditions.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02527876
Other Study ID Numbers  ICMJE 1505m70321
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Minnesota
Study Sponsor  ICMJE University of Minnesota
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alicia Allen, PhD University of Minnesota
PRS Account University of Minnesota
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP