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CTRI Number  CTRI/2025/12/098723 [Registered on: 10/12/2025] Trial Registered Prospectively
Last Modified On: 09/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Single Arm Study 
Public Title of Study   A study to determine whether the practice of reading followed by comprehension exercise and solving simple math problems as a group of 20 people for 5 days a week for 1 hour over a period of 3 weeks can improve the test scores of attention, concentration and memory in healthy older adults. 
Scientific Title of Study   Impact of arithmetic and reading comprehension exercises on the cognitive abilities of healthy elderly people 
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. Sravani Gaddipati 
Designation  Assistant Professor 
Affiliation  Gayatri Vidya Parishad Institute of Health Care and Medical Technology 
Address  Department of Psychiatry, Gayatri Vidya Parishad Institute of Health Care and Medical Technology, Maridi Valley, Marikavalasa, Visakhapatnam

Visakhapatnam
ANDHRA PRADESH
530048
India 
Phone  9538341749  
Fax    
Email  gaddipatisravani@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrSravani Gaddipati 
Designation  Assistant Professor 
Affiliation  Gayatri Vidya Parishad Institute of Health Care and Medical Technology 
Address  Department of Psychiatry, Gayatri Vidya Parishad Institute of Health Care and Medical Technology
Marikavalasa, Visakhapatnam
Visakhapatnam
ANDHRA PRADESH
530048
India 
Phone  9538341749  
Fax    
Email  gaddipatisravani@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrSravani Gaddipati 
Designation  Assistant Professor 
Affiliation  Gayatri Vidya Parishad Institute of Health Care and Medical Technology 
Address  Department of Psychiatry, Gayatri Vidya Parishad Institute of Health Care and Medical Technology
Marikavalasa, Visakhapatnam
Visakhapatnam
ANDHRA PRADESH
530048
India 
Phone  9538341749  
Fax    
Email  gaddipatisravani@gmail.com  
 
Source of Monetary or Material Support  
Gayatri Vidya Parishad Institute of Health Care and Medical Technology, Visakhapatnam 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrSravani Gaddipati  Gayatri Vidya Parishad Institute of Health Care and Medical Technology  Outpatient number 15, Psychiatry Outpatient, Outpatient Department
Visakhapatnam
ANDHRA PRADESH 
9538341749

gaddipatisravani@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONALETHICSCOMMITTEE(IECGVP)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy participants 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Arithematic and comprehension passages  These include 45 simple arithmetic exercises (addition, subtraction, multiplication, and division), and one 700-1500 word reading passage on various subjects, including but not limited to history, science, and lifestyle. Each reading passage will be accompanied by 5 comprehension questions related to basic facts presented within the reading passages.These exercises will be given for one hour a day, 5 days a week for 3 weeks 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Age above 60 years and should be able to speak and read English with a Hindi Mental Status Examination (HMSE) score more than or equal to 29 years and with an educational background of Diploma or equivalent, and graduation and should be able to provide a written informed consent and have a
Functional Assessment Staging Test (FAST) stage 1 or 2 
 
ExclusionCriteria 
Details  HMSE score less than 29 with a FAST stage greater than 2 with an inability to provide informed consent, suffering from a history of Severe psychiatric illness and recent history of cerebrovascular accident
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
We hypothesize that consistent practice of arithmetic and reading
exercises over several weeks will improve performance on neuropsychological
assessments on PGI memory scale
 
Assessment with PGI memory scale will be performed at the baseline and following intervention, at 3 weeks.  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   26/12/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

1.  Title of the study: Impact of Arithmetic and Reading Comprehension Exercises on

    Cognitive Abilities of Healthy Elderly People

2.  Introduction (Background and Justification):

·        ‘Cognitive functions” refers to includes attention, memory, language, orientation, praxis, executive functions, judgement, and problem-solving. (Deary et al., 2009).

·         The functions of processing speed, memory, reasoning, and executive functions are called fluid mental abilities, and they are known to reduce with age (Harada, Natelson Love, & Triebel, 2013).

·        Cognitive stimulation is listed as an important preventive factor for Dementia by the 2024 report of the Lancet standing commission (Livingston G.,2024).

·         Brain training games like simple arithmetic and reading aloud improved executive function and processing speed in elderly Japanese volunteers (Nouchi et. al (2012)

·        Reading and arithmetic in particular have been shown to improve cognition in the long-term and protect against cognitive decline and development of Alzheimer’s disease (Chang,Y.H.,2021, Smith,G.E.,2009, Singh,P.,2016).

·        Longitudinal studies of brain exercise and cognitive health are currently limited within the literature. Additionally, many studies have tested computer-based training activities, but have not assessed the efficacy of activities on paper, which may be more accessible for certain populations. Finally, studies about the cognitive health of elderly Indian adults are limited.

Aim:

The aim of this study is to understand the potential for brain exercises, specifically

arithmetic and reading, to improve the cognitive abilities of healthy elderly individuals

in the Indian population.

Objective:

 

To assess the impact of arithmetic and reading comprehension exercises on cognitive

abilities on the PGI Memory scale

Hypothesis: We hypothesize that consistent practice of arithmetic and reading

exercises over several weeks will improve performance on neuropsychological

assessments. 

3.  Methodology:

Subjects: The study will be performed on 20 healthy elderly people in the community attending walker’s clubs or senior citizens organizations. The members of the organizations will be informed about the study through their respective groups online or offline in their group meetings and interested participants will be recruited after obtaining written informed consent.

Sample size: 20

Inclusion criteria:

·       Age above 60 years

·       Speaking, reading English

·       Hindi Mental Status Examination (HMSE) score >/=29

·       Education: Diploma or equivalent and graduation

·       Providing written informed consent

·       Functional Assessment Staging Test (FAST) stage 1or 2

Exclusion Criteria:

·       HMSE score < 29

·       FAST stage >2

·       Inability to provide informed consent

·       H/o Severe psychiatric illness

·       History of CVA

·       H/o Uncontrolled Hypertension/ Diabetes

·       History of TBI

·       Medications known to impair cognitive functions

·       Diagnosed case of MCI/Dementia

Study Design: Open-label interventional study

Sample Size : 20

Instruments:

Participant Data Sheet

Hindi Mental Status Examination:

Hindi mental status examination (Ganguly & Ratcliff, 1994). It was prepared in 1995 by Ganguly et al. It is an adapted version of the Mini Mental Status Examination test developed by Folstein. It has items modified from MMSE: Orientation to time in closed sentences, place as per terms used here, task to assess attention is days of week backward instead of spelling WORLD/100-7, sentence for repetition, reading face rather than read instructions, telling a sentence instead of writing a sentence, copying diamond inside a square instead of pentagons, difference in 3 object recall. It measures cognitive functions that are impaired in dementia. It was validated in the Ballabgarh district in India and is widely used all over the world.

PGI memory scale (Pershad et al.,1978):

Tests of attention, working memory, visuospatial processing,Arithmetic and Reading Comprehension Exercises. It is a reliable test and a valid test to assess memory in elderly people (Pershad et al.,1978).

4.Procedure:

Participants will be assigned brain exercises once a day for three weeks. These include 45 simple arithmetic exercises (addition, subtraction, multiplication, and division), and one 700-1500 word reading passage on various subjects, including but not limited to history, science, and lifestyle. Each reading passage will be accompanied by 5 comprehension questions related to basic facts presented within the reading passages. Sessions may be conducted online or offline based on comfort of the participants as a group. In case of online session, link will be provided to the interested participants. In the case that participants have visual or auditory deficits, materials will be adapted to ensure participants can complete both the arithmetic and reading activities. Materials will be developed by experimenters daily. 

After three weeks, participants will take a second HMSE and PGI memory scale assessment. 

4.Data Management and Statistical Plan:  Data will be collected and stored in a confidential manner. Statistical analysis will be performed with a t-test to compare baseline and final scores on the HMSE and PGI-memory scale. Additionally, a repeated measures ANOVA will be performed to analyze differences between the two groups after 6 months to negative the influence of practice-effect. 
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