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
|
|
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
|
|
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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