| CTRI Number |
CTRI/2024/04/066420 [Registered on: 26/04/2024] Trial Registered Prospectively |
| Last Modified On: |
18/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
This study will help in finding the relationship between physical activity, perception of personal fitness and body image among women in menopausal transition stage |
|
Scientific Title of Study
|
Relationship between physical activity, self-perceived fitness and body image
among perimenopausal 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 |
Naraharisetty Naga Kanaka Durga |
| Designation |
MPT student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Room no.215
Department of Physiotherapy
Second floor,
Manipal College of Health Professions
Manipal Academy of higher education
Madhav Nagar
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9989168730 |
| Fax |
|
| Email |
naraharisetty.mchpmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Preetha R |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Room no. 215
Department of Physiotherapy
Second floor,
Manipal College of Health Professions
Manipal Academy of higher education
Madhav Nagar
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9945670669 |
| Fax |
|
| Email |
preetha.r@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Preetha R |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Room no. 215
Department of Physiotherapy
Second floor,
Manipal College of Health Professions
Manipal Academy of higher education
Madhav Nagar
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9945670669 |
| Fax |
|
| Email |
preetha.r@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital, Manipal, Udupi, Karnataka |
|
|
Primary Sponsor
|
| Name |
Manipal college of health professions |
| Address |
Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Karnataka, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Shripad Hebbar |
Kasturba hospital, Manipal |
Room number 1, Womens health Physiotherapy, near scan room,3rd floor, WH wards, Kasturba hospital, Manipal
Udupi
KARNATAKA |
9611786463
shripad.hebbar@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N959||Unspecified menopausal and perimenopausal disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
Perimenopausal women, Women who can understand English and Kannada |
|
| ExclusionCriteria |
| Details |
Any cardiorespiratory, neurological or musculoskeletal disorders which can affect
their physical function, Diagnosed psychiatric disorders/ major depression, Patients who are on
hormonal therapy, Acute febrile illness, Recent accidents/trauma, surgeries, Cancer patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Physical activity using International Physical Activity Questionnaire, Body image using Multidimensional Body-Self Relations Questionnaire, Self-perceived fitness using 10-point rating scale |
Once only as baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="94"
Sample Size from India="94"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="89" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/05/2024 |
| Date of Study Completion (India) |
26/12/2024 |
| 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)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Perimenopausal women undergo several body image issues which may
affect their physical and mental health. Disparity in the level of one’s self-perceived fitness and body
image issues may be a contributing factor to reduced physical activity. Hence, it is important to
understand the relationship between these factors. Practice of physical activity may have a positive
effect on women, thereby increasing self-esteem, producing positive body image. Few studies in the
existing literature show that there is an association between physical activity with self-perceived fitness
and physical activity with body image in women among western population. There are several studies
involving physical activity, self- perceived fitness and body image issues in adults, while it is
understudied in perimenopausal women.
Participants will be included based
on the screening criteria. Perimenopausal women who will be visiting Department of OBG and
Department of Physiotherapy will be recruited. Perimenopausal women from the community setting will
be recruited who will meet the inclusion criteria. After explaining the procedure in detail written informed
consent will be obtained from the selected participants. Demographics will be collected from the
participants. MBSRQ will be administered by investigator to assess body image. Self-perceived fitness
will be assessed using 10-point rating scale. International Physical Activity Questionnaire-SF will be
administered to assess physical activity. Participants will be requested to fill out a questionnaire and
return it to the investigator. Investigator will be present in the vicinity to clarify the doubts. Data will be
collected and analysed. |