| CTRI Number |
CTRI/2019/06/019503 [Registered on: 03/06/2019] Trial Registered Prospectively |
| Last Modified On: |
04/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Effect of physical activity on women whose having menopause |
|
Scientific Title of Study
|
Influence of physical activity on quality of life in postmenopausal women |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Adithi Nair |
| Designation |
Post-graduate Student |
| Affiliation |
School of Allied Health Sciences |
| Address |
School of Allied Health Sciences,Department of Physiotherapy MAHE Manipal-576104
Udupi
KARNATAKA
576104
India |
| Phone |
7349020367 |
| Fax |
|
| Email |
nairadithi@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arun G Maiya |
| Designation |
Dean ,Professor |
| Affiliation |
School of Allied Health Sciences |
| Address |
School of Allied Health Sciences,Department of Physiotherapy MAHE
Manipal-576104
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
ajmaiya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Preetha R |
| Designation |
Associate Professor |
| Affiliation |
School of Allied Health Sciences |
| Address |
School of Allied Health Sciences Department of Physiotherapy MAHE
Manipal-576104
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
preetha.r@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Adithi Nair |
| Address |
School of Allied Health Sciences,Department of Physiotherapy MAHE Manipal-576104 |
| Type of Sponsor |
Other [Self ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Adithi Nair |
Kasturba Hopsital,Manipal |
Department of Physiotherapy,Obg consultation room
Udupi
KARNATAKA |
7349020367
nairadithi@yahoo.com |
| Adithi Nair |
Kasturba Hopsital,Manipal |
Department of Physiotherapy,Obg physiotherapy consultation room
Udupi
KARNATAKA |
7349020367
nairadithi@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Kasturba Hospital Institutional Comittee |
Approved |
| Kasturba Hospital Institutional Ethics Comittee |
Approved |
| KH, Institutional Ethics Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Postmenopausal women |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
Physical activity promotion programme |
Volunteers will be given verbal advertisment and participants will be screened on the basis of inclusion and exclusion criteria.The procedure will be explained and written informed consent will be obtained from the participant who will meet inclusion criteria.
GPAQ,WHOQOL-BREF,Menopause rating scale,Body mass index,Fat percentage will be assessed at the baseline.An individualized physical activity promotion program will be implemented based on baseline physical activity level at the hospital when the patient comes for regular checkup of bone mineral densitometry.Adherence to physical activity program will be noted every week through phone alls and a log book will be maintained.Following 4weeks,progression in level of physical activty will be done.If any other activity included by the participant in this duration will be taken into account.Post 8weeks,all parameters will be assessed when patient comes for follow up. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Post menopausal women aged 40-50years of age |
|
| ExclusionCriteria |
| Details |
Acute cardiovascular events in past 1month, unstable cardiac diseases, uncontrolled hypertension, undergoing psychotropic medications, hormone replacement therapy, consuming birth control pills, diagnosed with orthopedic problems that restrict ambulation, absolute bed rest |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Screening of Physical activity using GPAQ(Global Physical Activity Questionniare) |
At the baseline and after 8 weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Menopause rating Scale Body mass index body fat percentage |
At the baseline,and after 8 weeks duration will be reassessed |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
Final Enrollment numbers achieved (Total)= "42"
Final Enrollment numbers achieved (India)="42" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/06/2019 |
| Date of Study Completion (India) |
15/03/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Once data collection is completed,study will be published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Approval from Institutional Research Committee(IRC),SOAHSis taken.Ethical clearance has been obtained from Institutional Ethics Committee(IEC),Kasturba Hospital.Study is registered under Clinical trial Registry of India(CTRI).Volunteers will be given verbal advertisement and participants will be screened on the basis of inclusion and exclusion criteria.The procedure will be explained and written informed consent will be obtained from the participants who will meet the inclusion criteria. Global physical activity questioniare,WHOQOL-BREF,Menopause rating Scale,body mass index and fat percentage will be assessed at the baseline.An individualized physical activity promotion program will be implented based on baseline physical activity level at the hospital when the patient comes for checkup of bone mineral densitometry. Adherence to physical activity program will be noted every week through phone calls and a log book will be maintained. Following 4weeks,progression in level of physical activity will be done.If any other activity included by the participant in this duration will be taken into account.Post 8weeks,all the parameters will be assessed when the patient comes for regular follow up. There are no risk involved in undergoing physical activity promotion programme. If the results are found out to be effective.it will helpful as a lifestyle modification in postmenopausal women. |