ExerciseUFFDANCT03518931
Understanding Fitness' Function in Determining Activity
A study testing Fitness testing in people with Exercise and Fitness, run by University of Minnesota.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Fitness testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,315 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2014to 30 Sep 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Greater then 18 years old and able to complete the 20-step test to estimate CRF.
Who cannot join
- 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
About this study
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.
Read the 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.
- Being tested
- Fitness testing
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fitness testingDiagnostic test
The intervention in this study was measuring cardiorespiratory fitness and muscular strength and providing normative data to subjects.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | This arm included individuals randomized to receiving fitness information only. |
| Intervention | Experimental | This arm included individuals randomized to having fitness assessments performed. Receives: Diagnostic Test: Fitness testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise vital sign
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)
Measured: Baseline to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study start20 Aug 2014
- Primary completion30 Sep 2016
- Study completion30 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ExerciseStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,315 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Olson, MD, Principal investigator, University of Minnesta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03518931
- Sponsor's protocol ID
- 1406M51128
- Acronym
- UFFDA
- Status last verified
- Apr 2018
- First submitted
- 5 Apr 2018
- Last updated
- 8 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Langland JT, Sathnur N, Wang Q, Olson APJ. Do assessments of cardiorespiratory and muscular fitness influence subsequent reported physical activity? A randomized controlled trial. BMC Sports Sci Med Rehabil. 2021 Jun 15;13(1):69. doi: 10.1186/s13102-021-00295-z.
PubMed 34130756
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Fitness' Function in Determining Activity
- ClinicalTrials.gov ID
- NCT03518931
- Acronym / sponsor ID
- UFFDA / 1406M51128
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,315 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 20 Aug 2014 (actual)
- Primary completion
- 30 Sep 2016 (actual)
- Study completion
- 30 Sep 2016 (actual)
- First posted
- 8 May 2018 (actual)
- 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 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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –This arm included individuals randomized to receiving fitness information only. |
| Intervention | Experimental | Diagnostic Test: Fitness testingThis arm included individuals randomized to having fitness assessments performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Greater then 18 years old and able to complete the 20-step test to estimate CRF.
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| Fitness testingThe intervention in this study was measuring cardiorespiratory fitness and muscular strength and providing normative data to subjects. | Diagnostic test | Intervention |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2018.
- Derived from this study: PubMed 34130756Langland JT, Sathnur N, Wang Q, Olson APJ. Do assessments of cardiorespiratory and muscular fitness influence subsequent reported physical activity? A randomized controlled trial. BMC Sports Sci Med Rehabil. 2021 Jun 15;13(1):69. doi: 10.1186/s13102-021-00295-z.
- Individual participant dataSharing planned: Undecided
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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.
Andrew Olson, MD principal investigator
University of Minnesta
Questions about this trial
What is this clinical trial studying?
A study testing Fitness testing in people with Exercise and Fitness, run by University of Minnesota.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 8 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Exercise vital sign (time frame: Baseline to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03518931, which also lists 1 linked publication.
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 8 May 2018.