| CTRI Number |
CTRI/2022/11/046951 [Registered on: 01/11/2022] Trial Registered Prospectively |
| Last Modified On: |
31/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Physical activity levels among people living in old age homes in coastal Karnataka |
|
Scientific Title of Study
|
Physical activity levels among older adults residing in long term care facilities in coastal Karnataka-a cross-sectional study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashuthosh U Nayak |
| Designation |
Post-Graduate student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Physiotherapy Manipal College of Health Professions MAHE Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9148848301 |
| Fax |
|
| Email |
ashuthosh.nayak@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Girish N |
| Designation |
Associate professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Physiotherapy Manipal College of Health Professions MAHE Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9886782114 |
| Fax |
|
| Email |
girish.n@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Kavitha Vishal |
| Designation |
assistant professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Physiotherapy Manipal College of Health Professions MAHE Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9986526077 |
| Fax |
|
| Email |
kavitha.vishal@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, Manipal College of Health Professions, MAHE, Manipal- 576104 |
|
|
Primary Sponsor
|
| Name |
Ashuthosh U Nayak |
| Address |
Department of Physiotherapy Manipal College of Health Professions MAHE Manipal |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ashuthosh U Nayak |
Dr.A V BALIGA HOME FOR SENIOR CITIZEN |
Room-Common activity room, Ashraya, Haradi, Bhramavar
Udupi
KARNATAKA |
9148848301
nayakashuthosh07@gmail.com |
| Ashuthosh U Nayak |
KARUNALAYA CHARITABLE TRUST |
Room-Dining hall, Karunalaya old age home, Bhramavar
Udupi
KARNATAKA |
9148848301
nayakashuthosh07@gmail.com |
| Ashuthosh U Nayak |
KUTEERA OLD AGE HOME |
Room-Dining hall, Kuteera old age home, Ambagilu
Udupi
KARNATAKA |
9148848301
nayakashuthosh07@gmail.com |
| Ashuthosh U Nayak |
OZANAM HOME FOR THE AGED |
Room- Dormitory room, Ozanam home for the aged, Kallianpur, Santhekatte
Udupi
KARNATAKA |
9148848301
nayakashuthosh07@gmail.com |
| Ashuthosh U Nayak |
SRI KRISHNA OLD AGE HOME |
Room-Corridor, Sri Krishna old age home, Moodabettu, Kodavoor
Udupi
KARNATAKA |
9148848301
nayakashuthosh07@gmail.com |
| Ashuthosh U Nayak |
VISHRANTHI DHAMA OLD AGE HOME |
Room-Dining hall, Vishranthi Dhama old age home, Adarshnagar, Manipal
Udupi
KARNATAKA |
9148848301
nayakashuthosh07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| DR. AV BALIGA HOME FOR SENIOR CITIZEN |
No Objection Certificate |
| KARUNALAYA CHARITABLE TRUST |
No Objection Certificate |
| Kasturba medical college and Kasturba hospital IEC-2 |
Approved |
| KUTEERA OLD AGE HOME |
No Objection Certificate |
| OZANAM HOME FOR THE AGED |
No Objection Certificate |
| SRI KRISHNA OLD AGE HOME |
No Objection Certificate |
| VISHRANTHI DHAMA OLD AGE HOME |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
No diagnosed health-condition |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Long term care facility residents who have stayed for more than or equal to one year. Residents cognitive status will be evaluated by using Mini COG scale and residents scoring more than two will be included. |
|
| ExclusionCriteria |
| Details |
Bed ridden residents or residents who need special care and attention on daily basis will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Physical Activity Scale for the Elderly (PASE) |
one time during baseline residents of old age home will be asked to fill the PASE questionnaire. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="183"
Sample Size from India="183"
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)
|
07/11/2022 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Permission is obtained from Institutional Research Committee, MCHP and Institutional Ethics Committee (IEC), Kasturba Hospital, Manipal and registration will be done in Clinical Trial Registry India. Contact details and Information on Long Term Care Facilities in Udupi, Dakshina Kannada and Karkala will be obtained from Department for the Empowerment of Differently Abled and Senior Citizen Udupi and Mangalore. Permission to conduct the study would be obtained from the administrators of the old age homes by establishing a telephonic call or by visiting the facility during clinical out postings. Permissions for old age homes from Mangalore and Karkala district is on-going. During first visit, residents will be screened for the inclusion and exclusion criteria. Next a participation information sheet will be given to residents who are willing to participate in the study, followed by informed consent will be taken. The investigator will sit next to the participant and will read out the questionnaire and fill it according to the participants answers.
|