NCT02527876

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 5, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 19, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

January 24, 2018

Status Verified

January 1, 2018

Enrollment Period

1.2 years

First QC Date

August 5, 2015

Last Update Submit

January 22, 2018

Conditions

Keywords

ExerciseSmoking

Outcome Measures

Primary Outcomes (1)

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

    12 weeks

Study Arms (3)

High Intensity Interval Training/FitBit Flex

EXPERIMENTAL

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

Behavioral: High Intensity Interval TrainingDevice: FitBit Flex

Moderate Intensity/FitBit Flex

EXPERIMENTAL

Meet with personal trainer once per week for 30-minute exercise session and exercise two times a week outside of personal trainer

Behavioral: Moderate IntensityDevice: FitBit Flex

Delayed Control/FtBit Flex

PLACEBO COMPARATOR

No exercise offered

Behavioral: Delayed ControlDevice: FitBit Flex

Interventions

High Intensity Interval Training

Also known as: FitBit Flex
High Intensity Interval Training/FitBit Flex

Moderate Intensity Training

Moderate Intensity/FitBit Flex
Delayed ControlBEHAVIORAL

Delayed Control

Delayed Control/FtBit Flex

Use to measure increase in Physical Activity

Delayed Control/FtBit FlexHigh Intensity Interval Training/FitBit FlexModerate Intensity/FitBit Flex

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DCRU

Minneapolis, Minnesota, 55414, United States

Location

MeSH Terms

Conditions

Motor ActivitySmoking

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Alicia Allen, PhD

    University of Minnesota

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2015

First Posted

August 19, 2015

Study Start

August 1, 2015

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

January 24, 2018

Record last verified: 2018-01

Locations