UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054744 |
|---|---|
| Receipt number | R000062561 |
| Scientific Title | Efficacy of Multi-Component Exercise-Based Injury Prevention Program on Injury Risk Among Recreational Runners: A Randomized Control Trial |
| Date of disclosure of the study information | 2025/01/02 |
| Last modified on | 2024/06/24 15:44:21 |
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Basic information
Public title
Reducing Running Injuries: An Exercise-Based Prevention Program
Acronym
ERIP: Exercise-Based Running Injury Prevention
Scientific Title
Efficacy of Multi-Component Exercise-Based Injury Prevention Program on Injury Risk Among Recreational Runners: A Randomized Control Trial
Scientific Title:Acronym
Scientific Title: EMERIT (Efficacy of Multi-Component Exercise-Based Injury Prevention Program on Injury Risk Among Recreational Runners: A Randomized Control Trial)
Region
| Asia(except Japan) |
Condition
Condition
Running related injury
Classification by specialty
| Orthopedics | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The narrative objectives of the study are to evaluate the effectiveness of a multi-component exercise-based injury prevention program in reducing the incidence and severity of running-related injuries among recreational runners. The study aims to assess whether the intervention decreases the overall risk of injuries, examines specific types of injuries affected by the program, and investigates participant adherence and satisfaction with the intervention protocols.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
The primary outcomes of the study include:
Incidence of Running-Related Injuries (RRIs): The number of self-reported RRIs over the 6 to 12-month study period, recorded biweekly.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Participants in this group were provided with an online multi-component exercise-based injury prevention intervention.
Interventions/Control_2
Participants in this group followed their regular preparation for running events without any additional intervention.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Participants were considered recreational runners if aged between 18 and 65, engaging in running for at least 10 km per week consistently over three months before completing the questionnaire.
Key exclusion criteria
Participants were excluded from the study if they were presently injured or recently injured within the past three months, as well as those with current pregnancy, history of lower limb surgery, and unwillingness to record running data.
Target sample size
260
Research contact person
Name of lead principal investigator
| 1st name | Aynollah |
| Middle name | |
| Last name | Naderi |
Organization
Shahrood University of Technology
Division name
Sport scinces
Zip code
3619995161
Address
Shahrud, Semnan Province
TEL
02332392202
Ay.naderi@shahroodut.ac.ir
Public contact
Name of contact person
| 1st name | Aynollah |
| Middle name | |
| Last name | Naderi |
Organization
Shahrood University of Technology
Division name
Sport scinces
Zip code
3619995161
Address
Shahrud, Semnan Province
TEL
02332392202
Homepage URL
ay.naderi@shahroodut.ac.ir
Sponsor or person
Institute
Shahrood University of Technology
Institute
Department
Personal name
Funding Source
Organization
Shahrood University of Technology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shahrood University of Technology
Address
Shahrud, Semnan Province
Tel
+982332392204
ay.naderi@shahroodut.ac.ir
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 24 | Day |
Last modified on
| 2024 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062561
