| CTRI Number |
CTRI/2026/01/100933 [Registered on: 13/01/2026] Trial Registered Prospectively |
| Last Modified On: |
12/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Impact Of Daily Movement Affects The Well-Being Of Women After Menopause |
|
Scientific Title of Study
|
Correlation Between Functional Mobility And Quality Of Life 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 |
Vishali K |
| Designation |
Student |
| Affiliation |
SRM college of physiotherapy,SRMIST,Kattankulathur. |
| Address |
Room no PT 23,4th floor,SRM College Of Physiotherapy, SRM medical college hospital and Research centre,SRMIST,
Kattankulathur
Room no PT 23,4th floor,SRM College Of Physiotherapy, SRM medical college hospital and Research centre,SRMIST,
Kattankulathur
Chennai
TAMIL NADU
603203
India |
| Phone |
9445891255 |
| Fax |
|
| Email |
vk4949@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subicha T S |
| Designation |
Assistant Professor |
| Affiliation |
SRM College Of Physiotherapy,Kattankulathur. |
| Address |
PT No. 14, SRM College Of Physiotherapy, SRM Institute Of Science And Technology ,
Kattankulathur
Chennai
TAMIL NADU
603203
India |
| Phone |
7200337170 |
| Fax |
|
| Email |
subichat@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Vishali K |
| Designation |
Student |
| Affiliation |
SRM College Of Physiotherapy,SRMIST,Kattankulathur. |
| Address |
Room no PT 23,4th floor,SRM College Of Physiotherapy, SRM medical college hospital and Research centre,SRMIST,
Kattankulathur
Room no PT 23,4th floor,SRM College Of Physiotherapy, SRM medical college hospital and Research centre,SRMIST,
Kattankulathur
Chennai
TAMIL NADU
603203
India |
| Phone |
9445891255 |
| Fax |
|
| Email |
vk4949@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM Nagar kattankulathur 603203 |
|
|
Primary Sponsor
|
| Name |
Vishali K |
| Address |
Room no PT 23,4th floor,SRM College Of Physiotherapy, SRM medical college hospital and Research centre,SRMIST,
Kattankulathur
Chennai
TAMIL NADU
603203
India |
| Type of Sponsor |
Other [Self Sponsor] |
|
|
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 |
| Dr Vishali K |
SRM medical college hospital and research centre,SRMIST,Kattankulathur |
Room no PT 23,4th floor,SRM College Of Physiotherapy, SRM medical college hospital and Research centre,SRMIST,
Kattankulathur
Chennai
TAMIL NADU |
9445891255
vk4949@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Medical College Hospital And Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
post menopausal women |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
1.Women who have attained natural menopause .
2.They should not undergone menstruation atleast for 12 consecutive months
3.Patient able to walk independently or with minimal support.
4.Volunteers
|
|
| ExclusionCriteria |
| Details |
1.Neurological disorder affecting mobility
2.They should not have been underwent any ortho surgeries for past 6 months
3.Psychological, chronic illness affecting mobility
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Outcome:
To Determine The Correlation Between Functional Mobility And Overall Quality Of Life QoL In Post-Menopausal Women Measured Using Validated Mobility Tests And a Standardized QoL Questionnaire
Secondary Outcome:
To quantify the strength and direction of association between specific functional mobility measures ( 2 Minute Walk Test, Berg Balance Scale,Single leg stance Test,Barthel index,Lawton instrumental ADL) and QoL domains (physical, psychological, social, environmental).
To compare QoL scores between participants with normal vs. impaired functional mobility
To identify which mobility component (gait speed, balance, endurance) is the strongest predictor of QoL after adjusting for age, BMI, comorbidities, and physical activity level.
To estimate the prevalence of functional mobility impairment in the study sample of post-menopausal women. |
baseline assessments |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To quantify the strength and direction of association between specific functional mobility measures (Timed Up and Go, 6-Minute Walk Test, Berg Balance Scale) and QoL domains (physical, psychological, social, environmental).
To compare QoL scores between participants with normal vs. impaired functional mobility (using predefined cutoffs for the mobility tests).
To identify which mobility component (gait speed, balance, endurance) is the strongest predictor of QoL after adjusting for age, BMI, comorbidities, and physical activity level.
To estimate the prevalence of functional mobility impairment in the study sample of post-menopausal women |
baseline assessments |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
23/01/2026 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Ethical
approval for the study will be obtained from the SRM Institutional Ethical
Committee prior to data collection. Participants will be recruited based on the defined inclusion and exclusion
criteria. The
purpose and procedures of the study will be clearly explained to all eligible
participants, and written informed consent
will be obtained prior to participation. A brief demographic data sheet will be administered to collect relevant
participant details such as age, menopausal status, and duration since
menopause. Participants will then complete the MENQOL (Menopause Specific Quality of Life)
questionnaire to assess menopause related quality of life. Functional
mobility will be assessed using the following standardized measures such as Gait Speed by 2 minute walk test, Balance Berg Balance Scale and Single Leg
Stance Test, Functional Independence is measured using Barthel Index and
Lawton Instrumental Activities of Daily Living (IADL) scale. All collected data will be statistically analyzed to determine the relationship
between menopausal quality of life and functional mobility parameters.
|