| CTRI Number |
CTRI/2024/07/070251 [Registered on: 09/07/2024] Trial Registered Prospectively |
| Last Modified On: |
18/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Factors leading to running-related injuries in runners-A 6-month study |
|
Scientific Title of Study
|
Factors affecting running-related musculoskeletal injuries in recreational runners-A 6-month prospective study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Omkar Salunkhe |
| Designation |
Post Graduate |
| Affiliation |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy |
| Address |
Anushaktinagar, Mumbai-400094
Mumbai (Suburban)
MAHARASHTRA
400094
India |
| Phone |
8291305329 |
| Fax |
|
| Email |
omkar.salunkhe2001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sona Kolke |
| Designation |
Professor and HOD |
| Affiliation |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy |
| Address |
First floor, room no.2, Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy,11/12 Thube Park, Shivajinagar,
Pune – 411 005
Pune
MAHARASHTRA
411005
India |
| Phone |
9371004121 |
| Fax |
|
| Email |
sona.sarma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Omkar Salunkhe |
| Designation |
Post Graduate |
| Affiliation |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy |
| Address |
Anushaktinagar, Mumbai-400094
Mumbai (Suburban)
MAHARASHTRA
400094
India |
| Phone |
8291305329 |
| Fax |
|
| Email |
omkar.salunkhe2001@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy |
|
|
Primary Sponsor
|
| Name |
Sancheti Institute of Orthopaedics and Rehabilitation College of Physiotherapy |
| Address |
Sancheti Institute for Orthopaedics and Rehabilitation College of
Physiotherapy 11/12, Thube Park, Shivaji Nagar, Pune 411005
MAHARASHTRA |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Omkar Salunkhe |
Baburao Sanas Sports Ground |
Saras Baug,Pune,Maharashtra-411030
Pune
MAHARASHTRA |
8291305329
omkar.salunkhe2001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Sancheti Institute for Orthopaedics and Rehabilitation Institutional Ethics Committee |
Approved |
| Sancheti Institute for Orthopaedics and Rehabilitation Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T07||Unspecified multiple injuries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1)Recreational runners who run for a minimum of 5 km per week.
2)Those who have been training for at least the past 1 year.
3)Those who have been injury-free for the past 6 months. |
|
| ExclusionCriteria |
| Details |
1)Those who have undergone lower limb surgeries.
2)Previous injury affecting the current training.
3)Pregnant women. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Baseline Questionnaire |
At baseline(0 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
2)Knee posture
3)Foot Posture Index
4)Navicular Drop Test
5)Trigger points
6)Q-angle
7)Muscle Tightness
8)Prone Bridge Test
9)Single-leg squat Test
10)Star Excursion Balance Test
11)Kinematic analysis
12)WHOQOL-BREF |
At baseline(0 weeks) |
13)Follow up Survey
14)Injury Report |
At the end of every 2 weeks |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
Final Enrollment numbers achieved (Total)= "250"
Final Enrollment numbers achieved (India)="243" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/07/2024 |
| Date of Study Completion (India) |
16/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
16/10/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Running is one of the most common and well-participated physical activities which helps in the improvement of musculoskeletal, cardiovascular, and psychological health. But despite its health benefits, running is also one of the most common causes of overuse injuries of the knee, ankle, and foot. Prevalence of the RRMIs is 44.6% with typically 50% of the runners experiencing an injury each year that prevents them from running and 25% of runners are injured at any given time. The causes of running-related musculoskeletal injuries(RRMIs) are not clearly understood. Thus, the present prospective study aims to study the pattern of running-related musculoskeletal injuries in recreational runners in Mumbai and Pune city of Maharashtra and to analyze the various factors associated with RRMIs.
Null Hypothesis: The demographics, running history, training characteristics, injury history, the posture of knee, ankle, and foot, trigger points, muscle tightness, muscle strength, footstrike pattern, quality of life are not the significant factors associated with running-related musculoskeletal injuries in recreational runners during a 6 month follow up.
Research Hypothesis: The demographics, running history, training characteristics, injury history, the posture of knee, ankle, and foot, trigger points, muscle tightness, muscle strength, footstrike pattern, and quality of life are significant factors associated with running-related musculoskeletal injuries in recreational runners during a 6 month follow up.
|