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impact of Cognitive Harmony Program on Cognitive Health at Ayushman Arogya Mandir among 40 to 60 years

Evaluating the Effect of the ICMR-NCTB Mudra Toolbox and Cognitive Harmony Program on Cognitive Health at Ayushman Arogya Mandir: A Multi-Centric, Mixed-Method, Pragmatic Quasi-Experimental Trial. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/02/080699
Enrollment
1832
Registered
2025-02-17
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F039- Unspecified dementia

Interventions

Intervention1: Cognitive Harmony Program: Physical Activity- 30 minutes per session (4 times per week), Yoga and Meditation - 30 minutes per session (4 times per week), Music-Based Intervention- 15 mi

Sponsors

INDIAN COUNCIL OF MEDICAL RESEARCH
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Individuals aged between 40 to 60 years with early signs of cognitive decline as assessed by the cognitive screening instrument i.e Montreal Cognitive Assessment tool(part of ICMR-NCTB Mudra toolbox) 2. Permanent residents within the service area of Ayushman Arogya Mandir Centers 3. Individuals capable of providing informed consent. 4. Able to read and write independently (minimum one year of formal education). 5. No history of severe psychiatric disorders that could interfere with study participation. 6. Not currently enrolled in any other interventional study.

Exclusion criteria

Exclusion criteria: 1. Diagnosis of severe dementia or any significant neurological disorder. 2. History of head trauma, infections, or other neurological conditions (excluding stroke or neurodegenerative diseases) that may contribute to cognitive impairment. 3. Terminal illness with a life expectancy of less than 6 months. 4. Severe hearing or visual impairments that would prevent participation. 5. Physical limitations that would impede regular attendance at study sessions. Expanded Exclusion Criteria: 1. Individuals undergoing treatment for any cognitive disorder unrelated to MCI or AD. 2. Recent or ongoing use of anti-dementia medications (e.g., donepezil, galantamine) during the study period. 3. Individuals with a high risk of adverse cardiovascular events during physical activities (e.g., yoga), inability to adjust activities according to program guidance, or failure to achieve recommended activity levels despite understanding instructions.

Design outcomes

Primary

MeasureTime frame
The study anticipates demonstrating significant improvements in cognitive function among participants of the Cognitive Harmony Program compared to control groups. Qualitative findings are expected to reveal positive participant experiences and identify areas for further enhancement of the program, contributing valuable insights into the integration of holistic health practices into cognitive care.Timepoint: Baseline, at 6 months, at 1 year

Secondary

MeasureTime frame
To conduct qualitative surveys from each group after the 12-month intervention period, to evaluate their experiences, perceived benefits, and any challenges encountered during the programTimepoint: at the end of 1 year of intervention.

Countries

India

Contacts

Public ContactDr U Venkatesh

Department of Community and Family Medicine, All India Institute of Medical Sciences, Gorakhpur, Uttar Pradesh

venkatesh2007mbbs@gmail.com08285681837

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026