CTRI

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CTRI Number

CTRI/2023/08/056000 [Registered on: 01/08/2023] Trial Registered Prospectively

Last Modified On:

29/05/2024

Post Graduate Thesis

Yes

Type of Trial

Observational

Type of Study

Cross Sectional Study

Study Design

Other

Public Title of Study

Assessing activity level in women after menopause with osteoporosis

Scientific Title of Study

Physical activity profiling in women with post-menopausal osteoporosis - An observational study

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Maitri Vora
Designation	Post graduate student
Affiliation	Manipal College of Health Professions, Manipal, Karnataka
Address	Department of Physiotherapy, Manipal College Of Health Professions, Manipal Academy of Higher Education, Manipal, Karnataka, India Udupi KARNATAKA 576104 India
Phone	9974052911
Fax
Email	maitri.mchpmpl2022@learner.manipal.edu

Details of Contact Person
Scientific Query

Name	Maitri Vora
Designation	Post graduate student
Affiliation	Manipal College of Health Professions, Manipal, Karnataka
Address	Department of Physiotherapy, Manipal College Of Health Professions, Manipal Academy of Higher Education, Manipal, Karnataka, India Udupi KARNATAKA 576104 India
Phone	9974052911
Fax
Email	maitri.mchpmpl2022@learner.manipal.edu

Details of Contact Person
Public Query

Name	Dr G Arun Maiya
Designation	Dean and Professor
Affiliation	Manipal College of Health Profession, Manipal, Karnataka
Address	Room no.1, Centre for Diabetic foot care and research, Department of Physiotherapy, Manipal college of Health professions, Manipal Academy of Higher Education, Manipal, Karnataka, India Udupi KARNATAKA 576104 India
Phone	9845350823
Fax
Email	arun.maiya@manipal.edu

Source of Monetary or Material Support

Kasturba Hospital, Manipal, Udupi, Karnataka

Primary Sponsor

Name	Maitri Vora
Address	Department of Physiotherapy, Manipal College Of Health Professions, Manipal Academy of Higher Education, Manipal, Karnataka, India
Type of Sponsor	Other [Self]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr G Arun Maiya	Kasturba Hospital	Room no. 1, Centre for diabetic foot care and research, Department of Physiotherapy, Manipal college of health professions, Manipal Academy of higher education, Manipal, Karnataka Udupi KARNATAKA	9845350823 arun.maiya@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

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: M810\|\|Age-related osteoporosis without current pathological fracture,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	NIL	NIL

Inclusion Criteria

Age From	45.00 Year(s)
Age To	65.00 Year(s)
Gender	Female
Details	Diagnosed with post-menopausal osteoporosis (t-score value less than or equal to -2.5), Women can be able to read English or Kannada

ExclusionCriteria

Details

Women with unstable cardio-respiratory disorder, severe osteoarthritis, neurological disorder, musculoskeletal disorder (joint stiffness, recent fracture, rheumatoid arthritis), and women taking medications like phenytoin, thyroid medication, corticosteroids

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Physical activity level using Global Physical Activity Questionnaire (MET- min/week)	At baseline

Secondary Outcome

Outcome	TimePoints
Categorization of participants in percentage based on t-scores	At baseline

Target Sample Size

Total Sample Size="214"
Sample Size from India="214"
Final Enrollment numbers achieved (Total)= "214"
Final Enrollment numbers achieved (India)="214"

Phase of Trial

N/A

Date of First Enrollment (India)

15/08/2023

Date of Study Completion (India)

13/01/2024

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="0"
Months="11"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

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

Permission to conduct the study is obtained from Institutional Research Committee(IRC), MCHP, MAHE, and Institutional Ethics Committee (IEC), Kasturba Hospital, Manipal. After obtaining approval, the study will be registered under the Clinical Trials Registry India (CTRI). Then, Postmenopausal women already diagnosed with osteoporosis will be screened thoroughly for inclusion and exclusion criteria. After explaining the procedure in detail written informed consent is taken from the selected participants. Demographic data will be taken. Body weight and Height will be measured relatively using a stadiometer and weighing machine. The Global Physical Activity Questionnaire (GPAQ) will be administered by the investigator to assess the level of physical activity. Participants will be asked to complete the questionnaire and give it to the investigator. If participants have any doubts about filling out the questionnaire, the investigator will be available for clarification. The collected data will be analyzed. Participants will be categorized according to their T-score as normal bone density, osteopenia, and osteoporosis. Participants will be also categorized according to their level of physical activity with the help of a score obtained from GPAQ.