NCT05317130

Brief Summary

The interest in Para sport is steadily increasing. A concern is, though, that elite Para athletes report a high incidence of injuries and illnesses. Altogether, there is an urgent need to prevent such incidents among athletes already suffering from an impairment. However, most of the existing training-based prevention programmes are not adapted or accessible to Para athletes. Also, recent research suggests that sports safety work advantageously should facilitate disease prevention and health promotion. Such intervention would hypothetically also have the potential to reduce injuries, illnesses and improve health among Para athletes. To allow full implementation, the intervention would need to be adapted to the Para athletes´ various impairments, abilities and sports. MAIN QUESTIONS TO BE ADRESSED

  • Can an evidence-based eHealth health promotion platform prevent sports injuries and illnesses in elite para athletes over 6 months, 12 months and 5 years?
  • Can such platform improve overall health parameters such as sleep, nutrition and mental health in elite para athletes and influence the performance parameters training quantity and training quality over 6 months, 12 months and 5 years?
  • Can such platform improve health literacy among Para athletes?

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
16mo left

Started Sep 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Sep 2022Sep 2027

First Submitted

Initial submission to the registry

February 14, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 7, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

April 7, 2022

Status Verified

March 1, 2022

Enrollment Period

5 years

First QC Date

February 14, 2022

Last Update Submit

March 30, 2022

Conditions

Keywords

Para sportSports injuriesAthlete healthHealth promotionHealth literacy

Outcome Measures

Primary Outcomes (3)

  • Incidence of sports injuries and illnesses 6 months following study start

    The incidence of sports injuries and illnesses is the primary outcome. Incidence data will be calculated as the number of injuries and illnesses per 1000 hours of sports exposure.

    The incidence will be followed up 6 months following study start

  • Incidence of sports injuries and illnesses 12 months following study start

    The incidence of sports injuries and illnesses is the primary outcome. Incidence data will be calculated as the number of injuries and illnesses per 1000 hours of sports exposure.

    The incidence will be followed up 12 months following study start

  • Incidence of sports injuries and illnesses 4 years following study start

    The incidence of sports injuries and illnesses is the primary outcome. Incidence data will be calculated as the number of injuries and illnesses per 1000 hours of sports exposure.

    The incidence will be followed up 4 years following study start

Secondary Outcomes (5)

  • Mental health 6 months following study start.

    Athlete mental health data will be followed up 6 months following study start.

  • Mental health 12 months following study start.

    Athlete mental health data will be followed up 12 months following study start.

  • Mental health 4 years following study start.

    Athlete mental health data will be followed up 4 years following study start.

  • Health literacy 6 months following study start.

    Health literacy data will be followed up 6 months following study start.

  • Health literacy 12 months following study start.

    Health literacy data will be followed up 12 months following study start.

Study Arms (1)

This is an observational study.

The cohort will consist of elite Para athletes (athletes with an impairment).

Other: Athlete health monitoring

Interventions

Observational study

This is an observational study.

Eligibility Criteria

Age18 Years - 66 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants from the Swedish and South African Paralympic programmes will be invited to participate in the study.

You may qualify if:

  • Being an registered para athlete in Sweden or South Africa
  • Having an athlete classification according to the International Paralympic Committee

You may not qualify if:

  • Age below 18 years, or older than 66
  • Being a non-classified athlete

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lund University

Lund, Skåne County, 221 00, Sweden

Location

MeSH Terms

Conditions

Diabetes MellitusHealth BehaviorIllness BehaviorLiteracyAthletic Injuries

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehaviorCommunicationWounds and Injuries

Central Study Contacts

Kristina Fagher, PhD

CONTACT

Jan Lexell, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 14, 2022

First Posted

April 7, 2022

Study Start

September 1, 2022

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

April 7, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

The is no plan to share IPD data with other researchers.

Locations