| CTRI Number |
CTRI/2025/01/079470 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
27/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Frailty Management Model for older people aged 60 years or above |
|
Scientific Title of Study
|
Development and Application of Frailty Management Model for Community Dwelling Elderly |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Indranil Saha |
| Designation |
Scientist E (Medical) |
| Affiliation |
ICMR Centre for Ageing and Mental Health. Indian Council of Medical Research |
| Address |
1st Floor, Department of Ageing & Mental Health, Division of Non-communicable Diseases, ICMR Centre for Ageing and Mental Health. Indian Council of Medical Research. Block DP 1, Sector V, Salt lake, Kolkata
Kolkata
WEST BENGAL
700091
India |
| Phone |
9830019016 |
| Fax |
|
| Email |
saha.indranil@icmr.gov.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Indranil Saha |
| Designation |
Scientist E (Medical) |
| Affiliation |
ICMR Centre for Ageing and Mental Health. Indian Council of Medical Research |
| Address |
1st floor, Department of Ageing & Mental Health, ICMR Centre for Ageing and Mental Health. Division of Non-communicable Diseases. Indian Council of Medical Research. Block DP 1, Sector V, Salt lake, Kolkata
Kolkata
WEST BENGAL
700091
India |
| Phone |
9830019016 |
| Fax |
|
| Email |
saha.indranil@icmr.gov.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Indranil Saha |
| Designation |
Scientist E (Medical) |
| Affiliation |
ICMR Centre for Ageing and Mental Health. Indian Council of Medical Research |
| Address |
1st floor, Department of Ageing & Mental Health, ICMR Centre for Ageing and Mental Health. Division of Non-communicable Diseases. Indian Council of Medical Research. Block DP 1, Sector V, Salt lake, Kolkata
Kolkata
WEST BENGAL
700091
India |
| Phone |
9830019016 |
| Fax |
|
| Email |
saha.indranil@icmr.gov.in |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
V. Ramalingaswami Bhawan, PO Box No. 4911 Ansari Nagar, New Delhi 110029, India |
| Type of Sponsor |
Government funding agency |
|
|
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 Indranil Saha |
ICMR Centre for Ageing and Mental Health |
1st floor, Department of Ageing & Mental Health, ICMR Centre for Ageing and Mental Health. Division of Non-communicable Diseases. Indian Council of Medical Research. Block DP 1, Sector V, Salt lake, Kolkata
Kolkata
WEST BENGAL |
9830019016
saha.indranil@icmr.gov.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ICMR Centre for Ageing and Mental Health |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
• Subjects aged 60 years or more residing in the study area permanently for more than 2 years
• Ability to speak and understand command |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Existing activities provided from NP NCD program towards elderly population aged 60 years or more |
1. Behaviour change: Communication campaigns to promote healthy behaviors, such as eating healthy foods, increasing physical activity, avoiding tobacco and alcohol, managing stress, and recognizing warning signs of cancer
2. Early diagnosis and management: Integrating with the primary health care system through NCD cells at different levels
|
| Intervention |
Frailty management model for frail, pre-frail and robust (non-frail/normal) elderly population separately |
1. Education to caregiver of elderly people through regular contact program / social media to do aerobic & resistance exercise regularly - one to two one-hour sessions per week for three to 12 months. Upper and lower-limb muscle strength and endurance will be improved with this exercise. In addition, body flexibility will be increased with a sense of balance & coordination. The exercise will be divided into three parts viz. warm-up, main exercise & cool down. (videos showing aerobic & resistance exercises will be circulated in WhatsApp group / social media particularly targeting elderly participants & caregivers).
2. Nutritional component (protein intake, calorie intake, balanced food, Mediterranean diet) (videos showing maintenance of nutritional status will be circulated in WhatsApp group / social media particularly targeting elderly participants & caregivers).
3. Health care professionals to regularly reinforce importance of exercise & nutrition during home visit or communication during Village Health Sanitation & Nutrition Day (VHSND).
4. Morbidity (non-communicable disease, common mental health disorders) management through existing non-communicable disease program. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects aged 60 years or more residing in the study area permanently for more than 2 years
2. Ability to speak and understand command
|
|
| ExclusionCriteria |
| Details |
1. Elderly subjects having cognitive impairment
2. Elderly subjects with some specific diseases that would restrict them for dietary and physical activity like heart disease, end-stage kidney disease, cancer, visual and hearing impairments, severe bone and joint diseases (e.g., severe osteoporosis, severe knee, or shoulder joint degeneration)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Frailty: It will be assessed by FAST scale both categorical and continuous assessment.
2.Fried frailty index: It encompasses components like nutritional status, physical activity, mobility, strength, energy. Its score ranges from 0 to 5. It identifies three categories as robust, pre-frail and frail.
3.Clinical frailty scale: It indicates overall level of fitness or frailty. |
Baseline, 3 months, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nutritional status: Nutritional status will be assessed by MNA scale. Final result will be compared with baseline nutritional assessment of the participants |
Baseline, 3 months, 6 months |
|
|
Target Sample Size
|
Total Sample Size="388"
Sample Size from India="388"
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)
|
15/03/2025 |
| 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="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Rationale: Frailty is one of the common geriatric syndromes and is a major challenge for the healthcare system. In our country, around 1/4th of older adults in rural areas are suffering from frailty (prevalence 24.7%–38.8%). Novelty: This proposal addresses the development of a frailty management model and its implementation among community-dwelling elderly people. Objectives: To develop & implement a frailty management model for community-dwelling elderly and to assess the effectiveness of this model. Methods: The study will be conducted in both urban and rural areas of West Bengal. In the first phase, from the available literature and evidence, a frailty management model will be prepared with the help of related stakeholders like geriatric specialists, nutrition specialists, neuromedicine specialists, physical medicine specialists, mental health specialists & public health specialists. After that, the proposed model will be validated by related experts by using the Delphi technique (qualitative). In the second phase, the prepared model will be implemented among community-dwelling elderly participants by implementation research design involving related stakeholders like family members, Urban Accredited Social Health Activists, ASHA, ANM, and CHO. In the third phase, the outcome of this frailty management model will be assessed on selected variables post-intervention 6 months and 12 months by quantitative assessment. Expected outcome: Development of a frailty management model for community-dwelling elderly population (robust, pre-frail & frail) in a modular format for an Indian setting and its implementation by training related healthcare workers and caregivers. The effectiveness of this frailty management model will also be assessed. |