| CTRI Number |
CTRI/2019/04/018628 [Registered on: 15/04/2019] Trial Registered Prospectively |
| Last Modified On: |
12/04/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Association between anthropometric measurements and back muscles endurance along with sex difference in young adults |
|
Scientific Title of Study
|
Association of anthropometric measurements, lumbar lordosis, gender based differences on flexor and extensor trunk muscle endurance in young adults |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| - |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shabnam Joshi |
| Designation |
Assistant Professor |
| Affiliation |
Guru Jambheshwar University of Science and Technology |
| Address |
9, Ground Floor,
Department of Physiotherapy,
Health Center,
Guru Jambheshwar University of Science and Technology,
Hisar.
Hisar
HARYANA
125001
India |
| Phone |
9729922466 |
| Fax |
|
| Email |
shabnamphysio@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shabnam Joshi |
| Designation |
Assistant Professor |
| Affiliation |
Guru Jambheshwar University of Science and Technology |
| Address |
9, Ground Floor,
Department of Physiotherapy,
Health Center,
Guru Jambheshwar University of Science and Technology,
Hisar.
HARYANA
125001
India |
| Phone |
9729922466 |
| Fax |
|
| Email |
shabnamphysio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rekha Chaturvedi |
| Designation |
Assistant Professor |
| Affiliation |
Guru Jambheshwar University of Science and Technology |
| Address |
101, First Floor,
Department of Physiotherapy,
Health Center,
Guru Jambheshwar University of Science and Technology,
Hisar.
Hisar
HARYANA
125001
India |
| Phone |
7206322394 |
| Fax |
|
| Email |
rekhachaturvedi85@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self (Manoj Purohit, (MPT)),
B-98, Block-B, Street No 10,
Shashi Garden, Mayur Vihar I, New Delhi- 110091. |
|
|
Primary Sponsor
|
| Name |
Department of Physiotherapy |
| Address |
Guru Jambheshwar University of Science and Technology,
NH 10, New Delhi- Rohtak- Sirsa National Highway,
Hisar-125001.
Haryana. |
| Type of Sponsor |
Research institution |
|
|
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 |
| Manoj Purohit |
Department of Physiotherapy |
Room No 4, Ground Floor,
Health Center,
Guru Jambheshwar University of Science and Technology,
Hisar.
Hisar
HARYANA |
8054790535
manojpurohit55@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Department Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Lumbar Lordosis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
- |
|
| ExclusionCriteria |
| Details |
1. Patients with symptomatic back pain
2. Thoracic and cervical pain
3. Spinal deformity
4. Any history of fracture in back and lower limb
5. History of neurological, orthopaedic and cardiopulmonary diseases
6. Congenital and acquired chest wall deformities |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Trunk muscle endurance (both flexors and extensors)
2. Lumbar lordosis |
Single time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Body mass index (BMI)
2. Waist circumference (WC) |
Single time |
|
|
Target Sample Size
|
Total Sample Size="354"
Sample Size from India="354"
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
|
N/A |
|
Date of First Enrollment (India)
|
22/04/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Back flexors and extensors endurance integral part of core stability which is essential for pain free ADL activities. Obesity, both general and abdominal, reduce the back muscle endurance which will affect the prolonged normal ADL activities like standing. Girls generally use high-heel foot wear which will reduce base of support and increase lumbar lordosis, whereas in boys accumulation of fat will be in abdomen which again increase the lumbar lordosis. It is well known than increased lumbar lordosis accellerate the low back pain hence increase the disability. The purpose of this study is to see association between anthropometric variables and lumbar lordosis with reference to gender difference. The significance of this study is that by identifying gender based correlation and lumbar lordosis will help the therapist to identify the young adults who may later develop low back pain and implement prehabilitative measures. |