| CTRI Number |
CTRI/2023/04/051282 [Registered on: 04/04/2023] Trial Registered Prospectively |
| Last Modified On: |
03/04/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
IS STRENGTH TRAINING SUPERIOR TO STRETCHING FOR IMPROVING HAMSTRING FLEXIBILITY IN INDIVIDUALS WITH HAMSTRING TIGHTNESS
|
|
Scientific Title of Study
|
IS ECCENTRIC TRAINING SUPERIOR TO STRETCHING FOR IMPROVING HAMSTRING FLEXIBILITY IN INDIVIDUALS WITH HAMSTRING TIGHTNESS
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| FMIEC/CCM/085/2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sheetal Vivek Pai |
| Designation |
Lecturer |
| Affiliation |
Father Muller Medical College |
| Address |
Father Muller Medical College,
Department of Physiotherapy, Father Muller Road, Kankanady, Mangalore
Father Muller Medical College,
Department of Physiotherapy, Father Muller Road, Kankanady, Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
6363194619 |
| Fax |
|
| Email |
sheetal120395@fathermuller.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Jaya P |
| Designation |
Lecturer |
| Affiliation |
Father Muller Medical College |
| Address |
Father Muller Medical College,
Department of Physiotherapy, Father Muller Road, Kankanady, Mangalore
Father Muller Medical College,
Department of Physiotherapy, Father Muller Road, Kankanady, Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9611057292 |
| Fax |
|
| Email |
jayakulal55@fathermuller.in |
|
Details of Contact Person
Public Query
|
| Name |
Sheetal Vivek Pai |
| Designation |
Lecturer |
| Affiliation |
Father Muller Medical College |
| Address |
Father Muller Medical College,
Department of Physiotherapy, Father Muller Road, Kankanady, Mangalore
Father Muller Medical College,
Department of Physiotherapy, Father Muller Road, Kankanady, Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
6363194619 |
| Fax |
|
| Email |
sheetal120395@fathermuller.in |
|
|
Source of Monetary or Material Support
|
| Father Mullers Medical College, Father Muller Road, Kankanady, Mangaluru |
| Funding will be managed by the 3 researchers involved in the study |
|
|
Primary Sponsor
|
| Name |
Sheetal Pai |
| Address |
Father Muller Medical College,
Department of Physiotherapy, Father Muller Road, Kankanady, Mangalore |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| SHEETAL VIVEK PAI |
Father Muller Medical College |
Father Muller Medical College,
Department of Physiotherapy, Father Muller Road, Kankanady, Mangalore
Dakshina Kannada
KARNATAKA |
6363194619
sheetal120395@fathermuller.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Hamstring Tightness
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Eccentric training |
The “hamstring lowers†protocol involves participants to kneel on the floor with upright trunk perpendicular to floor. Feet will be supported under a low bench or held by an assistant. Arms will be kept folded across chest and body will be lowered forward. Participants will lower their body until they can no longer hold their position, at which point the participant will be allowed to relax and use their arms to catch themselves as they reach the floor. Dosage of the exercise will be 2 sets of 5 repetitions each as per the protocol suggested by Mjolsnes et al. This will be a one day intervention |
| Intervention |
Static Stretching |
Subjects will perform a string stretch by standing erect with the left foot planted on the floor and the toes pointing forward. The heel of the foot to be stretched will be placed on a plinth/chair with the toes directed toward the ceiling. The subject will then flex forward at the hip, maintaining the spine in a neutral position while reaching the arms forward. The knee will remain fully extended. The subject will continue to flex at the hip until a gentle stretch is felt in the posterior thigh. Once this position is achieved, the subject will maintain this position for 30 seconds and repeat for 3 times. This will be a one day intervention |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Individuals with hamstring tightness |
|
| ExclusionCriteria |
| Details |
1. History of impairment to the knee, thigh, hip, or lower back for 1 year before the study
2. Subjects already involved in exercise program for trunk and lower extremities
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Knee extension range of motion with goniometer |
Baseline and immediately post treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Lumbar flexion range of motion with inch tape |
Baseline and immediately post treatment |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/04/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/04/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
One publication done previously in Critical Reviews in Physical and Rehabilitation Medicine. None for the current topic |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Hamstring
tightness leads to posterior pelvic tilt and increased lordosis of the lumbar
spine. There is limited evidence
to determine the effects a
single session of eccentric training on flexibility as well its comparison with
static stretching. Therefore, the study aims to determine if one
session of eccentric training will improve hamstring flexibility as compared to
one bout of static stretching. This study may help in reducing the risk of having postural
changes due to hamstring tightness that could result in musculoskeletal pain
and dysfunction. As the study will be conducted on asymptomatic individuals, it
will be a guiding tool for conducting trials on symptomatic individuals. |