| CTRI Number |
CTRI/2024/11/076435 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
16/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
SELF STRETCHING EXERCISES FOR LOWER BACK PAIN |
|
Scientific Title of Study
|
“Effects of self stretching exercises on managing lower back pain among young adulthood newbie male gym goers – a cross sectional study†|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NA |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NAGESWARI |
| Designation |
Associate professor |
| Affiliation |
Galgotias University |
| Address |
Room No 315, Schoolof Allied Health Science, Department of Physiotherapy, GALGOTIAS UNIVERSITY, SECTOR 17 A YAMUNA EXPRESSWAY, GREATER NOIDA, UTTAR PRADESH-203201
Room No 315, Schoolof Allied Health Science, Department of Physiotherapy, GALGOTIAS UNIVERSITY, SECTOR 17 A YAMUNA EXPRESSWAY, GREATER NOIDA, UTTAR PRADESH-203201
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
09843073406 |
| Fax |
|
| Email |
nagesmpt@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dharam Raj Chauhan |
| Designation |
Student |
| Affiliation |
Galgotias University |
| Address |
E 004, Schoolof Allied Health Science, Department of Physiotherapy, GALGOTIAS UNIVERSITY, SECTOR 17 A YAMUNA EXPRESSWAY, GREATER NOIDA, UTTAR PRADESH-203201
UTTAR PRADESH
203201
India |
| Phone |
09843073406 |
| Fax |
|
| Email |
dharamrajchauhan45@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
NAGESWARI |
| Designation |
Associate professor |
| Affiliation |
Galgotias University |
| Address |
Room No 315, Schoolof Allied Health Science, Department of Physiotherapy, GALGOTIAS UNIVERSITY, SECTOR 17 A YAMUNA EXPRESSWAY, GREATER NOIDA, UTTAR PRADESH-203201
Room No 315, Schoolof Allied Health Science, Department of Physiotherapy, GALGOTIAS UNIVERSITY, SECTOR 17 A YAMUNA EXPRESSWAY, GREATER NOIDA, UTTAR PRADESH-203201
UTTAR PRADESH
203201
India |
| Phone |
09843073406 |
| Fax |
|
| Email |
nagesmpt@gmail.com |
|
|
Source of Monetary or Material Support
|
| GALGOTIAS UNIVERSITY, plot No 2,sector 17 A Yamuna expressway, Greater Noida, uttarpradesh |
|
|
Primary Sponsor
|
| Name |
Galgotias University |
| Address |
GALGOTIAS UNIVERSITY, SECTOR 17 A, GAUTAM BUDDHA NAGAR, YAMUNA EXPRESS WAY, GREATER NOIDA |
| 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 |
| Nageswari |
Galgotias university |
Room No E004, E block first floor, School of Allied Health Science, Department of Physiotherapy, GALGOTIAS UNIVERSITY, SECTOR 17 A YAMUNA EXPRESSWAY, GREATER NOIDA, UTTAR PRADESH-203201
Gautam Buddha Nagar
UTTAR PRADESH |
09843073406
nagesmpt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DEPARTMENTAL RESEARCH COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
YOUNG ADULTHOOD NEWBIE MALE GYM GOERS |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Self stretching exercises |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Male |
| Details |
Young adulthood Male gym goers aged 18 to 25
New to gym workouts with reported lower back pain
Able to commit to a one-month treatment protocol
|
|
| ExclusionCriteria |
| Details |
Individuals with pre-existing chronic lower back conditions or serious medical issues.
Those not adhering to the treatment protocol or unable to complete the study.
Age group of more than 25 and less than 18
Females and transgenders
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reduction of pain |
One month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| increase in the performance in gym |
one month |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
11/11/2024 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Lower
back pain is a common issue faced by individuals who are new to gym workouts,
particularly among adult male gym goers. For beginners, engaging in physical
exercise can lead to a variety of musculoskeletal problems, with lower back
pain being one of the most prevalent. This pain can arise from improper
technique, overuse, or sudden increases in physical activity. As gym goers
adapt to new exercises and routines, their lower back muscles can become
strained or injured, leading to discomfort and potential hindrance in their
fitness journey. Addressing this issue is crucial as it can impact motivation
and overall adherence to a fitness program. Understanding effective management
strategies for lower back pain in this population is essential for both
short-term relief and long-term prevention. |