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CTRI Number  CTRI/2018/01/011090 [Registered on: 02/01/2018] Trial Registered Prospectively
Last Modified On: 02/09/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Brain training with mobile application and effect of it on quality of life of older adults 
Scientific Title of Study   Cognition and Technology: Quality of life of older adults 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dhara Abhinav Sharma 
Designation  Principal, Senior Lecturer 
Affiliation  Sharda College Of Physiotherapy 
Address  Principals cabin,Room No: 001, Sharda College of Physiotherapy Opp. Kailash Dham At & Post Pethapur Ta. Dist. Gandhinagar. 382610

Gandhinagar
GUJARAT
380058
India 
Phone  9726649064  
Fax    
Email  dhara23us@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dhara Abhinav Sharma 
Designation  Principal, Senior Lecturer 
Affiliation  Sharda College Of Physiotherapy 
Address  Principals cabin, room no: 001, Sharda College of Physiotherapy Opp. Kailash Dham At & Post Pethapur Ta. Dist. Gandhinagar. 382610

Gandhinagar
GUJARAT
380058
India 
Phone  9726649064  
Fax    
Email  dhara23us@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dhara Abhinav Sharma 
Designation  Principal, Senior Lecturer 
Affiliation  Sharda College Of Physiotherapy 
Address  Principals cabin, Room no: 001, Sharda College of Physiotherapy Opp. Kailash Dham At & Post Pethapur Ta. Dist. Gandhinagar. 382610

Gandhinagar
GUJARAT
380058
India 
Phone  9726649064  
Fax    
Email  dhara23us@gmail.com  
 
Source of Monetary or Material Support  
Dhara Sharma A-1 Vrajnandan II Aarohi Club Road Bopal Ghuma Road Ahmedabad 380058 Gujarat 
 
Primary Sponsor  
Name  Dhara Sharma 
Address  A-1, Vrajnandan II, Aarohi Club road, Opp Axis Bank, Bopal Ghuma road, Ahmedabad, 380058 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
None   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dhara Sharma  Ahmedabad Institute of Medical Sciences  AIMS campus Near Karnavati eye hospital Gota Vadsar Road Lapkaman Ahmedabad Gujarat 380060
Ahmadabad
GUJARAT 
9726649064

dhara23us@gmail.com 
Dhara Sharma  Sharda College Of Physiotherapy  Sharda Campus, Opp Kailash Dham, At and Post. Pethapur, Dist. Gandhinagar
Gandhinagar
GUJARAT 
9726649064

dhara23us@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Ahmedabad Institute Of Medical Sciences  Approved 
Sharda College Of Physiotherapy  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Mild cognitive impairment  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Cognitive training with aerobic exercises  The moderate intensity of aerobic exercise protocol will be given to the control group 
Intervention  Cognitive training with mobile based application  The mobile application Lumosity will be used to train the individuals for the cognition. Lumosity has collaborated to participate in the study without any funding and with no conflict of interest. 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Older adults
2. Both males and females
3. Age of 60 to 75 years
4. Individuals who have smartphones with internet connection
5. Mild cognitive impairment screened with ACE - III
6. Eligibility for aerobic training as per Physical activity readiness Questionnaire
 
 
ExclusionCriteria 
Details  1. Any neurological condition causing cognitive impairment
2. Impaired dexterity of upper limbs
3. Having visual impairment where eyesight cannot be corrected to normal level
4. Having hearing impairment where hearing cannot be corrected to normal level
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Addenbrookes Examination - III  Pre-intervention and post-intervention at the end of 8 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
Quality of Life Alzheimer disease  Pre-intervention and post-intervention at the end of 8 weeks  
Six minute walk test  Pre-intervention and post-intervention at the end of 8 weeks  
Neuro Cognitive Performance test  Pre-intervention and post-intervention at the end of 8 weeks  
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" 
Phase of Trial   N/A 
Date of First Enrollment (India)   16/01/2018 
Date of Study Completion (India) 01/03/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 01/03/2019 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Population ageing is a global phenomenon seen in developed as well as developing countries. As per the ministry of Statistics in India, the number of elderly in India has hit the all-time high. Aging brings age-related degenerative changes. Degeneration of Nervous system at old age causes cognitive impairment and degeneration of cardiorespiratory system causes a decrease in aerobic capacity.

Cognitive impairment and declined aerobic capacity have a detrimental effect on quality of life with hindrance in carrying out activities of daily living.  Mobile phone usage is increasing in India and mobile phone users are expected to rise to 703.7 million by 2017. Mobile based cognitive training may be one of the easiest modes of training and may also be cost effective.  On the other hand, there are abundant evidence suggestive importance of aerobic exercises in older adults, not only improving the aerobic capacity but also showing positive cognitive effects.

Though there is a wide variety of mobile applications available, yet, there is scant evidence on the effectiveness of these applications on cognition in India. Whereas, there is a wide range of researches available on the effect of aerobic exercises on older adults, also many of them proving the effect of aerobic exercises on cognition. Hence the need arises for the study to see the effect of mobile application based cognitive training on cognition and quality of life in older adults and also compare the effect of aerobic exercises and mobile-based application cognitive training on cognition and quality of life in older adults.

Hypothesis:

1.      There is no difference between the effect of aerobic training and mobile application based cognitive training on level of cognition in older adults

2.      There is no difference between the effect of aerobic training and mobile application based cognitive training on Quality of life in older adults

    3. There is no difference between the effect of aerobic training and mobile application based cognitive training on aerobic capacity in older adults

        Procedure:

       Those in Group A will be made to install the mobile-based application "Lumosity" for cognitive training. The participants will be instructed in detail about ‘how to play’. All the participants will be asked to ‘play’ for 5 days a week, for eight weeks. All the individuals in group A will be trained on all possible aspects of cognition.

       Group B will be given aerobic exercise protocol for eight weeks. They will be prescribed physical exercises in the form of the moderate intensity aerobic exercises regimen of 30 minutes, 5 days a week for eight weeks as per the ACSM guidelines for older adults. At the end of eight weeks, individuals of both the groups will be assessed for cognition and quality of life.    

             

       The data will be analysed using the appropriate statistical tool. Level of significance will be kept at 5%.


 
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