UFFDA: Understanding Fitness' Function in Determining Activity

• Sponsor: University of Minnesota (Other)
• Overall Status: Completed
• CT.gov ID: NCT03518931
• Collaborator: (none)
• Enrollment: 1,315
• Arms: 2
• Actual Duration (Months): 25.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Exercise; Fitness; Strength	Diagnostic Test: Fitness testing	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 1315 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Understanding Fitness' Function in Determining Activity
• Actual Study Start Date: Aug 20, 2014
• Actual Primary Completion Date: Sep 30, 2016
• Actual Study Completion Date: Sep 30, 2016

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Exercise vital sign [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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Minnesota

Investigators

• Principal Investigator: Andrew Olson, MD, University of Minnesta

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT03518931
• Other Study ID Numbers: 1406M51128
• First Posted: May 8, 2018
• Last Update Posted: May 8, 2018
• Last Verified: Apr 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of May 8, 2018