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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Recruitment Status : Withdrawn (Researcher left University)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

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.

Condition or disease Intervention/treatment Phase
Exercise, Delayed Control Behavioral: High Intensity Interval Training Behavioral: Moderate Intensity Behavioral: Delayed Control Device: FitBit Flex Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Exercise to Promote Quit Attempts in Young Adults
Study Start Date : August 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High Intensity Interval Training/FitBit Flex
Meet with personal trainer once per week for 20-minute exercise session
Behavioral: High Intensity Interval Training
High Intensity Interval Training
Other Name: FitBit Flex

Device: FitBit Flex
Use to measure increase in Physical Activity

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
Behavioral: Moderate Intensity
Moderate Intensity Training

Device: FitBit Flex
Use to measure increase in Physical Activity

Placebo Comparator: Delayed Control/FtBit Flex
No exercise offered
Behavioral: Delayed Control
Delayed Control

Device: FitBit Flex
Use to measure increase in Physical Activity




Primary Outcome Measures :
  1. Number of Participants With Increase in Physical Activity as assessed by FitBit [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02527876


Locations
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United States, Minnesota
DCRU
Minneapolis, Minnesota, United States, 55414
Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: Alicia Allen, PhD University of Minnesota
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT02527876    
Other Study ID Numbers: 1505m70321
First Posted: August 19, 2015    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018
Keywords provided by University of Minnesota:
Exercise
Smoking