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

Conditions

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.
Diagnostic test: Fitness testing
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

University of Minnesota

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.

General Publications

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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