| CTRI Number |
CTRI/2025/10/096161 [Registered on: 16/10/2025] Trial Registered Prospectively |
| Last Modified On: |
14/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Physiotherapeutic Treatment For Postmenopausal Women |
|
Scientific Title of Study
|
Effectiveness Of Technology Based And Conventional Physiotherapeutic Interventions On Musculoskeletal Bio Markers, Balance And Quality Of Life Among Postmenopausal 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 |
Priyadharshini P |
| Designation |
Assistant Professor |
| Affiliation |
Dr. M.G.R. Educational and Research Institute ,Chennai-77. |
| Address |
Faculty of Physiotherapy,Dr.M.G.R. Educational and Research Institute,Chennai-77.
Faculty of physiotherapy Dr.M.G.R.Educational and Research Institute,Velappanchavadi,chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
8608174351 |
| Fax |
|
| Email |
dharshinipriya1409@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Veenakirthika S |
| Designation |
Vice Principal / Joint Registrar |
| Affiliation |
Dr. M.G.R. Educational and Research Institute,Chennai-77. |
| Address |
Faculty of Physiotherapy
Dr. M.G.R. Educational and Research Institute,Velappanchavadi, Chennai-77.
Chennai
TAMIL NADU
600077
India |
| Phone |
9884224990 |
| Fax |
|
| Email |
veena.physio@drmgrdu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Veenakirthika S |
| Designation |
Vice Principal/Joint Registrar |
| Affiliation |
Dr. M.G.R. Educational and Research Institute,Chennai -77. |
| Address |
Faculty Of Physiotherapy,Dr. M.G.R.Educational and Research Institute,chennai-77.
Chennai
TAMIL NADU
600077
India |
| Phone |
09884224990 |
| Fax |
|
| Email |
veena.physio@drmgrdu.ac.in |
|
|
Source of Monetary or Material Support
|
| Faculty of Physiotherapy,Dr.M.G.R. Educational and Research Institute,Chennai-77. |
|
|
Primary Sponsor
|
| Name |
Priyadharshini P |
| Address |
Faculty of Physiotherapy,Dr.M.G.R. Educational and Research Institute,chennai-77. |
| Type of Sponsor |
Other [other(self)] |
|
|
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 |
| PRIYADHARSHINI P |
Physiotherapy Out Patient,A.C.S Medical College and Hospital |
Faculty of Physiotherapy,Dr.M.G.R. Educational and Research Institute, Chennai-77.
Chennai
TAMIL NADU |
8608174351
dharshinipriya1409@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr.M.G.R. Educational And Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
POSTMENOPAUSAL WOMEN WITH BALANCE PROBLEM REDUCED MUSCLE STRENGTH REDUCED BONE MINERAL DENSITY |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
technology based physiotherapy
whole body vibration technique 10 min per day (in ten sets of I min with vibration and 1 min break between vibration bouts)12 HZ /3 sessions for 12 weeks. |
conventional physiotherapy
warm up 15 mins, workout for 35 minutes resistance exercises by using dumbbells and Thera bands , cool down stretches 10 minutes/ 3times /per week for 12 weeks
|
| Intervention |
whole body vibration technique for 10 min per day (in ten sets of I min with vibration and 1 min break between vibration bouts)12 HZ /3 sessions/ per week for 12 weeks.Virtual reality - The training to be performed for 45 minutes in a day for 4 days in a week for strengthening exercises
|
conventional physiotherapy technique
warm up 15 mins, workout for 35 minutes resistance exercises by using dumbbells and Thera bands , cool down stretches 10 minutes/3times /12 weeks
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
Women with low bone mineral density with calcaneal ultrasound t-score between -1 to -2.5
BMI 25 -29.9 kg/m2 normal to overweight
|
|
| ExclusionCriteria |
| Details |
Postmenopausal Women with Neurological problem
postmenopausal Women undergone Hormonal replacement therapy
postmenopausal Women who are at risk of cancer
postmenopausal Women with cardiovascular diseases
menopausal women with recent fracture
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the technology based and conventional physiotherapuetic interventions on muscle strength, bone denisty, balance and quality of life among postmenopausal women |
To compare the technology based and conventional physiotherapuetic interventions on muscle strength, bone denisty, balance and quality of life among postmenopausal women this outcome for 8weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To improve the sleep quality
To reduce the stress, anxiety & depression |
To improve the sleep quality
To reduce the stress, anxiety & depression this outcome measure for 8 weeks. |
|
|
Target Sample Size
|
Total Sample Size="371"
Sample Size from India="371"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
28/10/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This study explores the association between musculoskeletal parameters, balance, and quality of life in postmenopausal women. A total of 371 participants were recruited based on specific inclusion and exclusion criteria and randomly allocated to study groups. The research focuses on key musculoskeletal factors including bone mineral density, muscle strength, and balance and their impact on overall quality of life. Findings from this study aim to highlight how targeted interventions can enhance bone health, improve physical stability, and significantly elevate the quality of life in postmenopausal women. |