- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03518931
Understanding Fitness' Function in Determining Activity (UFFDA)
April 25, 2018 updated by: University of Minnesota
The purpose of the study is to determine how measuring strength (by squeezing a tool called a hand grip dynamometer) and cardiorespiratory fitness (by climbing stairs) and sharing the results with subjects impacts exercise.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
The Understanding Fitness Function in Determining Activity (UFFDA) Study was initiated at the 2014 and 2015 Minnesota State Fair to determine if measuring muscular strength and CRF would motivate individuals to increase their physical activity.
Eligible individuals consented to participate and were randomized in a 1:1 allocation to control or intervention groups.
All participants provided their current Exercise Vital Sign (EVS calculated by multiplying the number of moderate-vigorous exercise sessions/week by the average minutes/session).
The intervention group had VO2max estimated using a timed previously validated Step Test and muscular strength measured using a Hand Dynamometer.
Results with age appropriate normative data for both grip strength and a "good or superior" VO2max were provided to the intervention group.
Our hypothesis was participants who receive the intervention would increase physical activity (measured by EVS) compared to control participants.
Study Type
Interventional
Enrollment (Actual)
1315
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
Greater then 18 years old and able to complete the 20-step test to estimate CRF.
Exclusion Criteria:
History of heart disease, Syncope, Chest pain, Dyspnea, Use of beta blockers, Use of non-dihydropyridine calcium channel blockers, Evidence of any unstable medical conditions. Pregnant
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
This arm included individuals randomized to receiving fitness information only.
|
|
Experimental: Intervention
This arm included individuals randomized to having fitness assessments performed.
|
The intervention in this study was measuring cardiorespiratory fitness and muscular strength and providing normative data to subjects.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exercise vital sign
Time Frame: Baseline to 1 year
|
The primary outcome of the study was change in exercise vital sign: (EVS calculated by multiplying the number of moderate-vigorous exercise sessions/week by the average minutes/session)
|
Baseline to 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Andrew Olson, MD, University of Minnesta
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 20, 2014
Primary Completion (Actual)
September 30, 2016
Study Completion (Actual)
September 30, 2016
Study Registration Dates
First Submitted
April 5, 2018
First Submitted That Met QC Criteria
April 25, 2018
First Posted (Actual)
May 8, 2018
Study Record Updates
Last Update Posted (Actual)
May 8, 2018
Last Update Submitted That Met QC Criteria
April 25, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- 1406M51128
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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