NCT04385472

Brief Summary

The investigators aimed to assess the impact of long-distance running on musculoskeletal system of runners, by doing high resolution magnetic resonance imaging analysis before and after marathon running.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

April 1, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 13, 2020

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

May 13, 2020

Status Verified

May 1, 2020

Enrollment Period

10 months

First QC Date

May 4, 2020

Last Update Submit

May 7, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in radiographic score after marathon running

    up to 1 year

  • Change in self-reported hip questionnaire after marathon running

    up to 1 year

Secondary Outcomes (1)

  • Number of participants who finished the training for/and the marathon vs not finishing

    up to 4 months

Interventions

3T MRIRADIATION

The main method used will be 3 Tesla MRI, which is a high resolution imaging technique. The participants will be asked to undergo musculoskeletal MRI scanning (pelvis and lumbar spine).MRI is a non-invasive procedure which excludes the risk of radiation (in comparison to other imaging modalities: X-ray, CT

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

asymptomatic long-distance runners

You may qualify if:

  • no previous marathon participations
  • no present or previous history of hip injuries or surgeries
  • asymptomatic hip joints
  • no contradindications to hip MRI scanning

You may not qualify if:

  • pregnant or breastfeeding women
  • individuals aged \<18 years
  • claustrophobia
  • history of anxiety or panic attacks
  • known hip problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal National Orthopaedic Hospital

London, United Kingdom

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Orthopaedics

Study Record Dates

First Submitted

May 4, 2020

First Posted

May 13, 2020

Study Start

April 1, 2019

Primary Completion

February 1, 2020

Study Completion

December 1, 2021

Last Updated

May 13, 2020

Record last verified: 2020-05

Locations