| CTRI Number |
CTRI/2024/03/064608 [Registered on: 21/03/2024] Trial Registered Prospectively |
| Last Modified On: |
13/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To check connection between how well older adults living in oldage home can move and how strong are their breathing muscles |
|
Scientific Title of Study
|
Relationship between physical performance and respiratory muscle strength among older adults residing in long-term care settings. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arjun A Achar |
| Designation |
PG student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Physiotherapy
Manipal College of Health Professions
MAHE Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7026353064 |
| Fax |
|
| Email |
arjun1.mchpmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaishali K |
| Designation |
Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Physiotherapy
Manipal College of Health Professions
MAHE Manipal
308,Cardiopulmonary rehabilitation unit, Department of Physiotherapy
Kasturba Hospital, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9353039762 |
| Fax |
|
| Email |
vaishali.kh@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaishali K |
| Designation |
Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Physiotherapy
Manipal College of Health Professions
MAHE Manipal
308,Cardiopulmonary rehabilitation unit, Department of Physiotherapy
Kasturba Hospital, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9353039762 |
| Fax |
|
| Email |
vaishali.kh@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, MCHP MAHE |
|
|
Primary Sponsor
|
| Name |
Arjun A Achar |
| Address |
Department of Physiotherapy, Manipal College of Physiotherapy, MAHE, Manipal 576104 |
| 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 |
| Arjun A Achar |
AV Baliga, Home for senior citizen |
Guest room 2nd floor, Dr. AV Baliga Memorial Hospital 6th Main, V. M. Nagar Doddanagudde, Udupi 576102
Udupi
KARNATAKA
Udupi
KARNATAKA |
7026353064
arjun1.mchpmpl2023@learner.manipal.edu |
| Arjun A Achar |
Karunalya oldage home |
Dinning hall ground floor, Karunalaya, Doopadakatte Herror post, Brahmavar 576213
Udupi
KARNATAKA
Udupi
KARNATAKA |
7026353064
arjun1.mchpmpl2023@learner.manipal.edu |
| Arjun A Achar |
Kuteera oldage home |
veranda ground floor, D.No. 3-3-10A, "Shanthi Sadana" Beedu Marga, Ambalpady Post, Udupi 576101
Udupi
KARNATAKA
Udupi
KARNATAKA |
7026353064
arjun1.mchpmpl2023@learner.manipal.edu |
| Arjun A Achar |
Ozanam Home For Aged |
Dinning hall ground floor, Maria Kripa Convent Kaliyanpur, Santhekatte 576105
Udupi
KARNATAKA
Udupi
KARNATAKA |
7026353064
arjun1.mchpmpl2023@learner.manipal.edu |
| Arjun A Achar |
Shri Krishna |
Dinning hall ground floor, Behind Moodubetta School, Post Krodashrama, Kodavoor, Udupi 57610
Udupi
KARNATAKA
Udupi
KARNATAKA |
7026353064
arjun1.mchpmpl2023@learner.manipal.edu |
| Arjun A Achar |
Vishranthi Dhama |
Visitors hall ground floor, Adarsha nagara, Manipal 576104 Udupi
Udupi
KARNATAKA
Udupi
KARNATAKA |
7026353064
arjun1.mchpmpl2023@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research) |
Approved |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research) |
No Objection Certificate |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research) |
No Objection Certificate |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research) |
No Objection Certificate |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research) |
No Objection Certificate |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research) |
No Objection Certificate |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research) |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Older adults (60-80years) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1) Older adults of age 60-80 years
2) Living in long-term care facility for more than 6 months
3) Both genders
4) Ability to walk unaided
5) Willingness to take part in the study
|
|
| ExclusionCriteria |
| Details |
1) Cognitive score less than 3 in Mini-Cog scale
2) Critically ill or terminally ill
3) Known case of cardiorespiratory, musculoskeletal, neurological and metabolic disorders which restrict mobility.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Physical performance
(Short physical performance battery)
Respiratory muscle strength
(Micro rpm) |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hand grip strength |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="87"
Sample Size from India="87"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/04/2024 |
| Date of Study Completion (India) |
Date Missing |
| 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 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
|
To look at the relationship between physical performance (performing daily activity) and respiratory muscle strength (breathing muscle strength) among older people living in long-term care settings for more than 6 months. A total of 87 participants will be included based on the following eligibilty criteria. Inclusion criteria: 1) Older adults of age 60-80 years. 2) Living in a long-term care facility for more than 6 months 3) Both genders 4) Ability to walk unaided 5) Willingness to take part in the study Exclusion criteria: 1) Cognitive score less than 3 in the Mini-Cog scale 2) Critically ill or terminally ill conditions such as kidney failure, stroke and cancer etc. 3) Known cases of cardiorespiratory, musculoskeletal, neurological and metabolic disorders which restrict mobility. It is an observational study. Participants will be screened based on the eligibility criteria and those who fulfill the criteria and willing to participate in the study will be included. One-time assessment of physical performance and respiratory muscle strength in older individual living in long-term care setting will be performed. Total study duration is 1 year. |