- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04548141
Quick Questionnaire to Evaluate Physical Activity (SAPHIR)
June 23, 2022 updated by: DENISE JOLIVOT, University Hospital, Angers
Simplification de l'évaluation de l'Activité PHysique Par Interrogatoire Rapide
The purpose of this study is to test and validate a new questionnaire (SAPHIR) in order to get an evaluation of patients physical activity.
Study Overview
Detailed Description
Two questionnaires the SAPHIR and the "International Physical Activity Questionnaire" (IPAQ) are submitted (self completion) to patients referred for consultation.
Retrival of physical activity data on podometer if available
Study Type
Interventional
Enrollment (Actual)
140
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Angers, France, 49933
- Centre hospitalier universitaire
-
-
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:
- French Native language
- Covered by the French social care system
- Be referred for a consultation to the Sports Medicine Service of Angers Hospital or to the CRSS of Angers
Exclusion Criteria:
- Person opposed to participating in the research
- Person unable to understand the objectives of the study
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: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Active adults
Adults coming for a visit for sports activity participation and submitted the SAPHIR questionnaire
|
Scoring of the IPAQ is performed according to references.
Scoring of the SAPHIR has been submitted for copyright protection (involves a series of 23 additions)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of questionnaires with errors after self completion
Time Frame: 1 day
|
Estimation of the percentage of errors with 90% confidence interval Comparison of the two percentages
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Facility of the filling of the questionnaires
Time Frame: 1 day
|
Ease of use évaluation for the patient using Likert scale (from "Totally agree" to "not agree at all" in 5 grades)
|
1 day
|
|
Correlation of the SAPHIR questionnaire to the IPAQ questionnaire
Time Frame: 1 day
|
Correlation coefficient with the IPAQ questionnaire
|
1 day
|
|
Correlation of the SAPHIR questionnaire to the number of weekly steps for patients who have a pedometer available
Time Frame: 1 day
|
The correlation coefficient with the number of steps will be studied
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Pierre ABRAHAM, University and Hospital in Angers
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)
November 26, 2020
Primary Completion (ACTUAL)
September 21, 2021
Study Completion (ACTUAL)
September 21, 2021
Study Registration Dates
First Submitted
September 8, 2020
First Submitted That Met QC Criteria
September 8, 2020
First Posted (ACTUAL)
September 14, 2020
Study Record Updates
Last Update Posted (ACTUAL)
June 24, 2022
Last Update Submitted That Met QC Criteria
June 23, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SAPHIR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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