| CTRI Number |
CTRI/2025/06/089794 [Registered on: 30/06/2025] Trial Registered Prospectively |
| Last Modified On: |
24/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Creating an Easy to use Physical Activity Questionnaire for Seniors in Indian Nepali Communities |
|
Scientific Title of Study
|
Cross-Cultural Adaptation of Physical Activity Scale for the Elderly (PASE) into Indian Nepali Language |
| Trial Acronym |
CAPE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sourav Thapa |
| Designation |
Post Graduate Student |
| Affiliation |
Sikkim Manipal College of Physiotherapy |
| Address |
Central Referral Hospital, Department of Physiotherapy, 5th mile Tadong,Gangtok, East Sikkim, Sikkim India.
Central Referral Hospital, Department of Physiotherapy, 5th mile Tadong,Gangtok, East Sikkim, Sikkim India.
East
SIKKIM
737102
India |
| Phone |
8794707144 |
| Fax |
|
| Email |
sourav.thapa2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bishal Bista |
| Designation |
Associate Professor |
| Affiliation |
Sikkim Manipal College of Physiotherapy |
| Address |
Central Referral Hospital, Department of Physiotherapy, 5th mile Tadong,Gangtok, East Sikkim, Sikkim India.
Central Referral Hospital, Department of Physiotherapy, 5th mile Tadong,Gangtok, East Sikkim, Sikkim India.
East
SIKKIM
737102
India |
| Phone |
9593782814 |
| Fax |
|
| Email |
bishal.b@smims.smu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Frieda P Bokali |
| Designation |
Lecturer |
| Affiliation |
Sikkim Manipal College of Physiotherapy |
| Address |
Central Referral Hospital, Department of Physiotherapy, 5th mile Tadong,Gangtok, East Sikkim, Sikkim India.
Central Referral Hospital, Department of Physiotherapy, 5th mile Tadong,Gangtok, East Sikkim, Sikkim India.
East
SIKKIM
737102
India |
| Phone |
9593372169 |
| Fax |
|
| Email |
friedabokali.e@smims.smu.edu.in |
|
|
Source of Monetary or Material Support
|
| Central Referral Hospital, 5th mile Tadong,Gangtok, East Sikkim, Sikkim India.737102 |
|
|
Primary Sponsor
|
| Name |
Sourav thapa |
| Address |
Central Referral Hospital, Department of Physiotherapy, 5th mile Tadong,Gangtok, East Sikkim, Sikkim India. 737102 |
| Type of Sponsor |
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 |
| Dr Sourav Thapa PT |
Central Referral Hospital (Community Based) |
5th mile Tadong, Gangtok, East Sikkim, Sikkim India. 737102
East
SIKKIM |
8794707144
sourav.thapa2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMIMS Institution Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Geriatric |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Individuals who can read and understand Nepali and English Language. |
|
| ExclusionCriteria |
| Details |
1. Unwillingness to participate.
2.Cognitive impairments. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Validity of the questionnaire |
Short-term retest (24-48 hours) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
Nil |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
10/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/07/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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 is conducted with an aim for conducting a cross-cultural adaptation of Physical Activity Scale for the Elderly questionnaire into Indian Nepali language for improving the overall accessibility and use of the questionnaire in assessing the level of physical activity ibn elderlies communicating i n Nepali language. |