Condition category
Musculoskeletal Diseases
Date applied
30/05/2017
Date assigned
29/06/2017
Last edited
03/10/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The psychological well-being of an individual is defined by the dynamic balance between personal needs and the external environment. In the case of disabled people, their usually is a natural unbalance of needs/potentialities and environment which makes it even more urgent to pursue the enhancement of psychological (mental) well-being, addressing the integration in a positive and gratifying context that could promote personal evolution. Sport activities, especially at agonistic (individual or team sports) level, are likely the most effective means for the practical realisation of this strategy. The aim of this study is to investigate whether agonistic sport affects the self-perceived psychological and emotional well-being of disabled young people.

Who can participate?
Youth aged 12 to 23 who are participating in the European Para-Youth Games 2017 and young disabled people who do not practice agonistic sports.

What does the study involve?
Participants are asked to fill in a questionnaire to assess their mental and emotional well-being. This can be done in person, online, or face to face using the assistance of a relative. The results from the Paralympic athletes are compared to the results of the reference population which is the young disabled people who do not practice agonistic sports.

What are the possible benefits and risks of participating?
There are no notable benefits or risks with participating.

Where is the study run from?
This study is run by the Institute of Neurology, Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health University of Genoa (Italy)

When is the study starting and how long is it expected to run for?
April 2017 to February 2018

Who is funding the study?
University of Genoa (Italy)

Who is the main contact?
Dr Luca Puce
Luca.puce@alice.it

Trial website

Contact information

Type

Scientific

Primary contact

Dr Luca Puce

ORCID ID

http://orcid.org/0000-0003-0825-2707

Contact details

Institute of Neurology
Department of Neuroscience
Rehabilitation
Ophthalmology
Genetics
Maternal and Child Health
University of Genoa
L.go P. Daneo
3
Genoa
I-16132
Italy

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

None

Study information

Scientific title

Do questionnaires on self-perceived psychological and emotional well-being administered to young Paralympic athletes, as compared to disabled people that do not practice agonistic sport, provide evidence of the positive role of agonistic sport?

Acronym

Study hypothesis

The aim of this study is to investigate whether agonistic sport affects the self-perceived psychological and emotional well-being of disabled young people.

Ethics approval

Ethics approval as of 03/10/2017: Ethics committee CER-Liguria (regional ethical committee of region Liguria, Italy, 02/10/2017, ref: 351REG2017

Previous ethics approval: Ethic approval was not required, as this work is an observational study involving administration and answering of questionnaires, that are well-established and internationally validated scientific tools. No administration of drugs is involved. No formal procedures with ethics boards have been registered.

Study design

Single-centre cross-sectional study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Physical disability

Intervention

Participants include young Paralympic athletes from the European Para-Youth Games 2017, as well as a reference population. Participants are randomised as belonging to different European countries and age from 12 to 23 years old.

Participants at the European Para-Youth Games 2017 are administered the questionnaires to complete. The questionnaire includes the Psychological General Well-Being Index (PGWBI) and the Short Form SF-12 index questionnaires. These questionnaires are well established and validated scientific tools, used to assess the self-perceived psychological and emotional well-being of young Paralympic athletes as compared young disabled people that do not practice agonistic sports. The questionnaires take under 30 minutes to fill-in and they can be either self-administered or administered in the form of a face-to-face interview with the assistance of a relative. The survey is anonymous.

The reference population (that include disabled youth who do not practice sport) are recruited by contacting psychiatry clinics across European countries taking part in the event (European Para-Youth Games, 9-15 October 2017). In this case, contact people are identified and are given instructions for administration of the questionnaires and assistance. Moreover, the link to the questionnaires are posted in the web page of the event European Para-Youth Games 2017, which will be reached not only by disabled athletes, but also by disabled non-athletes. Social media (Facebook) will further disseminate the link to the questionnaire.

Both groups complete the same questionnaires.

Intervention type

Phase

Drug names

Primary outcome measures

1. Psychological well-being is measured using the Psychological General Well-Being Index (PGWBI).
2. Emotional well-being is meaured using the Short Form SF-12 index.

Secondary outcome measures

1. Demographics (gender, age range, country, type of disability) are measured using questionnaires.
2. Physical well-being is measured using the Short Form SF-12 index

Overall trial start date

01/04/2017

Overall trial end date

01/02/2018

Reason abandoned

Eligibility

Participant inclusion criteria

Population under examination:
1. Participants in an international event, the European Para-Youth Games, 9-15 October 2017, Liguria, Italy
2. Age range 12-23
3. Both genders

Reference population of a similar number of subjects:
1. Young disabled people that do not practice agonistic sport
2. Recruited via clinics in Europe and at events for disabled peoples

Participant type

Other

Age group

Other

Gender

Both

Target number of participants

800-1200 for the population under study and equal number for the reference population

Participant exclusion criteria

Aged under 12 or over 23 years old

Recruitment start date

01/09/2017

Recruitment end date

31/12/2017

Locations

Countries of recruitment

Albania, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Latvia, Luxembourg, Montenegro, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom

Trial participating centre

Institute of Neurology, Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health University of Genoa, Genoa, Italy
L.go P. Daneo, 3
Genoa
I-16132
Italy

Sponsor information

Organisation

University of Genoa

Sponsor details

Institute of Neurology
Department of Neuroscience
Rehabilitation
Ophthalmology
Genetics
Maternal and Child Health
L.go P. Daneo
3
Genoa
I-16132
Italy

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

University/education

Funder name

University of Genoa

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Funding will be obtained from a private sponsor of the event "European Para-Youth Games 2017". Negotiation to get financial support is underway with the company ERG (Edoardo Raffinerie Garrone - ERG S.p.a), via the regional section of the Italian Paralympic Committee, CIP-Liguria

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

As for dissemination, the close relationship of this project with an international event (European Para-Youth Games, 9-15 October 2017, Liguria, Italy) that will be given very broad media coverage will provide a natural dissemination channel through the media themselves. Furthermore, the principal investigator of this project being part of the organization staff of the event will further enhance the dissemination potential of this close relationship.

A press conference of announcement of the event has already taken place 24 and therein the forthcoming collaboration of the organization of the event with the institution of the authors of the present work (University of Genoa) was pointed out. Similarly, articles appeared on general-scope newspapers and news sites have mentioned this collaboration. It is plausible to assume that this represents the beginning of a significant media coverage from mainstream news channels, through press releases. Moreover, information about this project will be conveyed not only on the official web site of the event but also on the web sites of all the involved organizations (International Paralympic Committee IPC, Italian Paralympic Committee CIP, Italian Federation of Paralympic Swimming FINP, Italian Federation of Paralympic and Experimental Sports FISPES, Italian Federation of Paralympic Sport for Intellectual and Relational Disabilities FISDIR, Italian Federation of Paralympic Sport for visually impairment disabilities FISPIC, Italian Federation of Archery FITARCO, Italian Federation of Sailing FIV, Italian Federation of Table Tennis FITET). Finally dissemination via social networks will be also extensive (hashtag #epyg2017).

The results of this work will be also published on scientific medical journals whose mission is related to quality of life and sport and presented at scientific congresses.

IPD sharing statement:
Data will be available on request from the principal investigator of this research Luca Puce at Luca.puce@alice.it

Intention to publish date

01/04/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

03/10/2017: Ethics information has been updated.