| CTRI Number |
CTRI/2024/11/077054 [Registered on: 19/11/2024] Trial Registered Prospectively |
| Last Modified On: |
16/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
EXERCISES FOR POST MENOPAUSAL WOMEN |
|
Scientific Title of Study
|
Impact of 8 weeks aerobic exercises on reducing non specific low back pain and improving the flexibility among Post menopausal women |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
C 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
Thanjavur
TAMIL NADU
203201
India |
| Phone |
9843073406 |
| Fax |
|
| Email |
nagesmpt@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shruti Tyagi |
| Designation |
|
| 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
E 004 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 |
8287750323 |
| Fax |
|
| Email |
nagesmpt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
C 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
TAMIL NADU
203201
India |
| Phone |
9843073406 |
| Fax |
|
| Email |
nagesmpt@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room No 315, Schoolof Allied Health Science, Department of Physiotherapy, GALGOTIAS UNIVERSITY, SECTOR 17 A YAMUNA EXPRESSWAY, GREATER NOIDA, UTTAR PRADESH-203201 |
|
|
Primary Sponsor
|
| Name |
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 |
| 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 |
| DrC Nageswari |
Galgotias university |
E Block, Ground floor, Room no E004, 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 |
Post menopausal women non specific low back pain |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
advice on general physical activity without a structured exercise program |
advice on general physical activity without a structured exercise program |
| Intervention |
The structured 8-week aerobic exercise |
The structured 8-week aerobic exercise intervention, including the type, duration, intensity, and frequency of exercise, applied to the experimental group. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Diagnosed with nonspecific low back pain for at least 3 months.
Able to perform moderate-intensity aerobic exercise as determined by a medical screening.
No engagement in regular aerobic exercise programs (less than 2 times per week) prior to the study.
Willingness to participate in an 8-week structured aerobic exercise program.
Ability to provide informed consent
|
|
| ExclusionCriteria |
| Details |
History of recent surgery or injury in the lower back or other parts of the musculoskeletal system. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of non specific low back pain |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Increased flexibility and functional performance |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
27/11/2024 |
| 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
|
Nonspecific
low back pain (NSLBP) is a common condition affecting post-menopausal women due
to various physiological, hormonal, and lifestyle factors. Effective,
non-invasive treatments are essential for improving the quality of life in this
population. While aerobic exercise is known for its cardiovascular benefits,
its impact on reducing NSLBP in post-menopausal women remains underexplored.
This study seeks to investigate the effectiveness of an 8-week aerobic exercise
program in reducing NSLBP and improving functional outcomes among
post-menopausal women. |