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WithdrawnNCT02527876EASY-AUpdated Jan 24, 2018

Exercise, Activity and Smoking in Young Adults

An interventional study of High Intensity Interval Training and Moderate Intensity in Exercise, Delayed Control, sponsored by University of Minnesota. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-24.

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

Why this study was withdrawn
Researcher left University
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate how physical activity levels change in young adults when they start a specific exercise program.

Read the 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.

02

Conditions studied

  • Exercise, Delayed Control

Keywords

  • Exercise
  • Smoking
03

In context

Lead sponsor

University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.

Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    High Intensity Interval Training/FitBit Flex

    Meet with personal trainer once per week for 20-minute exercise session

    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

    Behavioral: Moderate Intensity · Device: FitBit Flex

  • Placebo comparator
    Delayed Control/FtBit Flex

    No exercise offered

    Behavioral: Delayed Control · Device: FitBit Flex

Interventions

  • BehavioralHigh Intensity Interval Training

    High Intensity Interval Training

    Also known as: FitBit Flex

  • BehavioralModerate Intensity

    Moderate Intensity Training

  • BehavioralDelayed Control

    Delayed Control

  • DeviceFitBit Flex

    Use to measure increase in Physical Activity

06

What researchers measure

Primary outcomes

  1. Number of Participants With Increase in Physical Activity as assessed by FitBit

    Time frame: 12 weeks

07

Study locations

1 site
  • DCRU
    Minneapolis, Minnesota 55414, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 24, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02527876
Lead sponsor
University of Minnesota
Responsible party
Sponsor
First posted
Aug 19, 2015
Start date
Aug 2015
Primary completion
Oct 2016
Completion
Oct 2016
Last update
Jan 24, 2018

Study contacts

Alicia Allen, PhD
principal investigator · University of Minnesota

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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