Exercise, Delayed ControlEASY-ANCT02527876
Exercise, Activity and Smoking in Young Adults
A study testing High Intensity Interval Training, Moderate Intensity and FitBit Flex in people with Exercise, Delayed Control, run by University of Minnesota at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise, Delayed Control
- What is being tested?
- High Intensity Interval Training, Moderate Intensity and FitBit Flex
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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,
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exercise to Promote Quit Attempts in Young Adults
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.
- Conditions
- Exercise, Delayed Control
- Being tested
- High Intensity Interval Training, Moderate Intensity, Delayed Control, FitBit Flex
- Keywords
- Exercise, Smoking
- Medical subject headings
- Motor Activity, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Interval TrainingBehavioural
Also called FitBit Flex
High Intensity Interval Training
Moderate IntensityBehavioural
Moderate Intensity Training
Delayed ControlBehavioural
Delayed Control
FitBit FlexDevice
Use to measure increase in Physical Activity
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Interval Training/FitBit Flex | Experimental | Meet with personal trainer once per week for 20-minute exercise session Receives: Behavioral: High Intensity Interval Training; Device: 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 Receives: Behavioral: Moderate Intensity; Device: FitBit Flex |
| Delayed Control/FtBit Flex | Placebo comparator | No exercise offered Receives: Behavioral: Delayed Control; Device: FitBit Flex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Increase in Physical Activity as assessed by FitBit
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionOct 2016
- Study completionOct 2016
Why it stopped: Researcher left University
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise, Delayed ControlStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alicia Allen, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02527876
- Sponsor's protocol ID
- 1505m70321
- Acronym
- EASY-A
- Status last verified
- Jan 2018
- First submitted
- 5 Aug 2015
- Last updated
- 24 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise to Promote Quit Attempts in Young Adults
- ClinicalTrials.gov ID
- NCT02527876
- Acronym / sponsor ID
- EASY-A / 1505m70321
- Conditions
- Exercise, Delayed Control
- Keywords
- Exercise, Smoking
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Researcher left University
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 19 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Intensity Interval Training/FitBit Flex | Experimental | Behavioral: High Intensity Interval Training, Device: FitBit FlexMeet with personal trainer once per week for 20-minute exercise session |
| Moderate Intensity/FitBit Flex | Experimental | Behavioral: Moderate Intensity, Device: FitBit FlexMeet with personal trainer once per week for 30-minute exercise session and exercise two times a week outside of personal trainer |
| Delayed Control/FtBit Flex | Placebo comparator | Behavioral: Delayed Control, Device: FitBit FlexNo exercise offered |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 18-40 years old,
- stable physical/mental health,
- current smoker
- currently minimally active,
- ambulatory,
Key exclusion criteria (14 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Intensity Interval TrainingAlso: FitBit FlexHigh Intensity Interval Training | Behavioural | High Intensity Interval Training/FitBit Flex |
| Moderate IntensityModerate Intensity Training | Behavioural | Moderate Intensity/FitBit Flex |
| Delayed ControlDelayed Control | Behavioural | Delayed Control/FtBit Flex |
| FitBit FlexUse to measure increase in Physical Activity | Device | Delayed Control/FtBit Flex, High Intensity Interval Training/FitBit Flex, Moderate Intensity/FitBit Flex |
Primary outcome
Number of Participants With Increase in Physical Activity as assessed by FitBit
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2018.
Related trials for Exercise, Delayed Control
Recruiting
Mineral-Infused Clothing for Recovery From Muscle Soreness and Muscle Damage After Exercise
Delayed Onset Muscle Soreness, Exercise-Induced Muscle Damage
Recruiting
Timing of Specific Exercise Therapy After Breast Cancer Surgery: Early Versus Delayed Initiation
Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alicia Allen, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Interval Training, Moderate Intensity and FitBit Flex in people with Exercise, Delayed Control, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Increase in Physical Activity as assessed by FitBit (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2018.