Physical Activity Clinical Trial
Official title:
Protocol for a Non-randomized Survey to Evaluate Social Skills and Physical Capacity Improvement in Down Syndrome People Who Routinely Practice Sports. Self and Observers´ Perception.
This survey arises from one objective of a PhD thesis whose purpose is to "Identify what social skills people with Down syndrome have that do a routine activity and compare them with those developed by those SD people who perform sports activities."
This study is a non-randomized survey. The aim of the current protocol is to describe how
will be the process to get information about the participant, the questionnaire design and
how was validated and the planned analysis of results.
Participants: Around 150 Down Syndrome people from Cordoba, Malaga y Granada who belong to
The Down Syndrome association and 150 parents, family, tutors, teachers etc.
Consent process: Before designing the survey, consent was requested from the management team
Down of Córdoba, Malaga and Gradana associations, as well as family members, parents, tutors,
teachers, etc.
Standard Operating Procedures: First, RC (author) gathered as much information as possible
about the subject under study and selected the most important topics related to the research
focus. After that, the questionnaire was designed modifying the KidsLife-Down Scale. The
questionnaire will be divided into three parts.
An introduction to the questionnaire describes the instructions, structure, the reasons for
the study and confidentiality in accordance with the Spanish Organic Law 3/2018 on the
Protection.
The first part of the questionnaire will assess self-perception from people with Down about
their social skills. The second will evaluate the opinion of this issue from other people who
know them well (at least for six months) and who have the opportunity to observe the person
evaluated for extended periods of time (parents, family, tutors, teachers etc.). Finally, for
the third part, it will be used the International Physical Activity Questionnaire (IPAQ) for
the purpose of collecting information about the types of physical activity do in their daily
routines. The questions will be referred to the time they have been physically active in the
last 7 days.
Second, the questionnaire was sent to the Down Syndrome Association of Córdoba (DSAC) so that
they reviewed the possible mistakes made when defining the questions and validate it. After
that, Down Malaga and Down Granada Association found the questionnaire understandable and
acceptable.
Third, they gave the corresponding feedback that served to formulate the questions in the
appropriate way to avoid confusion in the surveyed.
The questionnaire will be sent by e-mail to the Cordoba Association and a paper version will
available for participants. From Córdoba, it will be spread to Málaga and Granada
Associations in order it will be distributed among associates.
Analysis of results: Estimated outcomes will be percentages of agreement with each answer.
Data from all surveys will be analyzed. The statistical study will be carried out with the
SPSS 24.0 program. The mean value and standard deviation (± SD) of each item will be
calculated on a numerical scale. Statistical analysis will be performed with parametric
tests, t-Student for related samples. The level of statistical significance will be
calculated.
Two of the authors (RC and JC) will analyse de data, and results will be discussed among the
work team.
Conducting a pilot test or pre-test before applying the survey will help to detect possible
failures and optimize the results of our survey. Despite its importance, should not consider
the pilot study as a substitute for a careful wording of the questionnaire.
Report on the survey: Before writing the report, It will be reviewed the data for errors and
inconsistencies. Make sure the data reflects exactly what the survey concludes. The
conclusion will summarize the results.
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