| CTRI Number |
CTRI/2025/01/078932 [Registered on: 17/01/2025] Trial Registered Prospectively |
| Last Modified On: |
04/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To Study The Relationship Between Core Endurance, Hamstring Flexibility And Pelvic Tilt On Low Back Pain In Cyclists |
|
Scientific Title of Study
|
The Influence Of Core Endurance, Hamstring Flexibility And Pelvic Tilt On Low Back Pain In Cyclists: A Cross-Sectional 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 |
Dr Dhaval Chivate |
| Designation |
Associate Professor |
| Affiliation |
KAHER institute of Physiotherapy |
| Address |
Advanced Physiotherapy Center, Department of Sports Physiotherapy, Room no.08, Sagar Floor, KLE Dr. Prabhakar kore hospital and MRC, Nehru Nagar, Belagaum, karnataka India
Belgaum
KARNATAKA
590010
India |
| Phone |
8494869771 |
| Fax |
|
| Email |
dhavalchivate@klekipt.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dhaval Chivate |
| Designation |
Associate Professor |
| Affiliation |
KAHER institute of Physiotherapy |
| Address |
Advanced Physiotherapy Center, Department of Sports Physiotherapy, Room no.08, Sagar Floor, KLE Dr. Prabhakar kore hospital and MRC, Nehru Nagar, Belagaum, karnataka India
Belgaum
KARNATAKA
590010
India |
| Phone |
8494869771 |
| Fax |
|
| Email |
dhavalchivate@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Mascarenhas Rasilia Marlien |
| Designation |
Postgraduate Student |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced Physiotherapy Center, Department of Sports Physiotherapy, Room no.08, Sagar Floor, KLE Dr. Prabhakar kore hospital and MRC, Nehru Nagar, Belagaum, karnataka India 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
7760284542 |
| Fax |
|
| Email |
rasiliamascarenhas@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Dr. Prabhakar kore Hospital and Research Center, Nehru Nagar, Belagavi karnataka , India 590010 |
|
|
Primary Sponsor
|
| Name |
KAHER Institute of Physiotherapy |
| Address |
KAHER Institute of Physiotherapy, JNMC Campus, Nehru Nagar, Belagavi Karnataka India 590010 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Dhaval Chivate |
KAHER Institute Of Physiotherapy |
Advanced Physiotherapy Center, Department of Sports Physiotherapy, Room no.08, Sagar Floor, KLE Dr. Prabhakar kore hospital and MRC, Nehru Nagar, Belagaum, karnataka India
Belgaum
KARNATAKA |
8494869771
dhavalchivate@klekipt.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RESEARCH AND ETHICAL COMMITTEE,KAHER INSTITUTE OF PHYSIOTHERAPY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M545||Low back pain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Amateur Cyclist (Type-Road cyclist).
History of Low back pain during Training or after long Tour.
Cycling (2-4 hrs per week) .
Train on regular Basis (3-5 days per week)
cyclist who have at least 1 years of cycling experience. |
|
| ExclusionCriteria |
| Details |
Cyclists who are intensively training other sports(swimming and running).
Undergone spinal or hamstring surgery.
Diagnosed with spinal pathology or lower extremity injury.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of core endurance by MC Gills test, Hamstring Flexibility using Active knee Extension test, Pelvic Tilt using APECS(AI Posture Evaluation And Correction System) and Oswestry Disability Index for low back Pain. |
All outcome measures will be evaluated during a single session at time based on Athletes Availability. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Oswestry low back pain Disability Index. |
Single session, at the time of participant assessment. |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
Final Enrollment numbers achieved (Total)= "16"
Final Enrollment numbers achieved (India)="16" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
29/01/2025 |
| Date of Study Completion (India) |
30/05/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
- Cyclists under intense training with prolonged sitting time and aerodynamic drag force can lead to postural deviations of spine, increase pelvic inclination and lumbar flexion.
- A loss of ability to control core muscle, hamstring muscle shortening might exhibit alter trunk and pelvic motion patterns .
- Aerodynamic drag reduces cycling efficiency and adopt forward leaning position lead to pelvic inclination.
- This is a Cros-sectional study aims to investigate the relationship between core endurance, hamstring flexibility and pelvic tilt in cyclists who are experiencing low back pain using Mc Gills test, Active knee extension test ,APECS app and Oswestry disability index to find if there is an association between these variables or any one is more significantly related to severity or prevalence for low back pain in Cyclists
- Also, there is limited studies done on Indian cyclists with less insight on body posture awareness on cycling biomechanics.
|