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CTRI Number  CTRI/2018/12/016520 [Registered on: 03/12/2018] Trial Registered Prospectively
Last Modified On: 09/05/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [an acute bout of exercise]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of an acute bout of exercise on cognition 
Scientific Title of Study   PSYCHOPHYSIOLOGICAL EVALUTATION OF THE EFFECT OF DIFFERENT INTENSITIES OF AEROBIC EXERCISE AMONG HEALTHY INDIVIDUALS – A RANDOMIZED CONTROL STUDY 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Monica Jasti 
Designation  Post-Graduate 
Affiliation  M.S. Ramaiah Medical College 
Address  Department of Physiology, M.S. Ramaiah Medical College, Mathikere, Bangalore.

Bangalore
KARNATAKA
560054
India 
Phone  9591649285  
Fax    
Email  dr.moni9492@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vasanthi Ananthakrishnan 
Designation  Professor and Heafd 
Affiliation  M.S. Ramaiah Medical College 
Address  Department of Physiology, M.S. Ramaiah Medical College, Mathikere, Bangalore.

Bangalore
KARNATAKA
560054
India 
Phone  9880373409  
Fax    
Email  dr_vasanthi_a@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Monica Jasti 
Designation  Post-Graduate 
Affiliation  M.S. Ramaiah Medical College 
Address  Department of Physiology, M.S. Ramaiah Medical College, Mathikere, Bangalore.

Bangalore
KARNATAKA
560054
India 
Phone  9591649285  
Fax    
Email  dr.moni9492@gmail.com  
 
Source of Monetary or Material Support  
Monica Jasti 
 
Primary Sponsor  
Name  Monica Jasti 
Address  Department of Physiology, M.S. Ramaiah Medical College, Mathikere, Bangalore-560054 
Type of Sponsor  Other [Self] 
 
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 
Dr Monica Jasti  M.S. Ramaiah Group of Institutios  M.S. Ramaiah Group of Institutions, MSR Nagar, Mathikere, Bangalore-560054
Bangalore
KARNATAKA 		 9591649285

SearchofMJ@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Commitee, M.S. Ramaiah Medical College and Hospitals  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  apparently healthy with no known past or present history of non-communicable disorders 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  An acute bout of exercise.  The grouping is based on the intensity of exercise the participant has to perform. Three groups will be allotted for different intensities (measured using maximum heart rate) of an aerobic exercise in the form of Harvard 2 step test wherein, heart rate maximum of 70 - 80% (Severe), 60 - 70% (moderate) & 50 – 60% (mild) will be the three exercise intervention groups, as a maximum heart rate of more than 80% would indicate anaerobic level of exhaustion. Once recruited, the data collection will be done as follows: The subject is asked to relax for 5 minutes in sitting position and then an open eye EEG (Neurosky MindWave4) will be recorded. A battery of cognitive ability testing for various cognitive abilities such as like attention, vigilance, visual search, spatial and numerical recognition, memory and executive functioning along with cognitive flexibility such as the trail making B-test, in which the ability is measured in seconds, are considered. The 3 intervention arms will be performing different intensities of aerobic exercise (mild, moderate & severe) for 5 minutes. After intervention, an open eye EEG recording will be done followed by cognitive assessment (post intervention). The duration of the complete protocol will be about 30-45 minutes per subject.  
Comparator Agent  staying sedentary  Once recruited, the data collection will be done as follows: The subject is asked to relax for 5 minutes in sitting position and then an open eye EEG (Neurosky MindWave) will be recorded. A battery of cognitive ability testing for various cognitive abilities such as like attention, vigilance, visual search, spatial and numerical recognition, memory and executive functioning along with cognitive flexibility such as the trail making B-test, in which the ability is measured in seconds, are considered. The 3 intervention arms will be performing different intensities of aerobic exercise (mild, moderate & severe) for 5 minutes. The control arm will be sedentary, in sitting position with open eyes, for the same duration. After intervention, an open eye EEG recording will be done followed by cognitive assessment (post intervention). The duration of the complete protocol will be about 30-45 minutes per subject.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  Apparently healthy individuals. 
 
ExclusionCriteria 
Details  1) History of non-communicable disorders.
2) History of mental disorders
3) Alcoholics and smokers
4) On any treatment protocols that affect EEG or cognition
5) Any other health condition that could alter the EEG
6) Unable to perform the exercise due to any structural or functional deformity or derangement. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
estimating the effects of different intensities of aerobic exercise on the EEG waves and cognitive ability of young adults.  1 year. 
 
Secondary Outcome  
Outcome  TimePoints 
estimating gender differentiation in the influence of an acute bout of exercise on cognitive ability and brain activity(EEG).  1 year. 
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/08/2019 
Date of Study Completion (India) 10/09/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 10/09/2020 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

The influence of regular aerobic exercise on an individual’s physical and mental health has been looked into, but, only a few studies have quantified the intensity or evaluated the effects of an acute bout of exercise. Older age groups have received more focus, to the best of our knowledge. Thus, we plan to study the change in cognition and EEG waves after an acute bout of exercise of different intensities, among young adults.

Varied intensities of exercise can have varied psychophysiological aspects of a person similar to the cardiorespiratory and muscular effects. Clear knowledge of influence of exercise on psychophysiological aspects can help in employing customized physical activity to the general population. This can help improve the quality of life greatly by attenuating cognitive decline that begins to occur at a very early age.

 A lack of numerous studies explaining the effects of different intensities of exercise on cognition was noted after an elaborate review of literature. This study was designed to know the effects of an acute bout of varied intensities of aerobic exercise on the cognitive ability and electrical activity of the brain among young and healthy individuals.

Hundred participants were recruited and randomly allocated into groups. Pre and post exercise cognitive assessment and EEG recording were obtained and analysed to understand the variation.

 It was noted that maximum benefits on cognition as well as EEG recordings were seen among the participants performing high intensity aerobic exercise. Distinct cognitive benefits were also noted with lower moderate intensity aerobic exercise. The younger age group usually has a health and physical status that can support regular performance of high intensity exercise. A habit of regular high intensity physical activity can help the younger age group delay the onset of cognitive decline. A lower moderate intensity exercise can be adviced to the people of older age groups in order to maintain compliance. It helps them in attenuating the cognitive decline among these individuals and provide them with an improved quality of life for the rest of years.

The knowledge of the influence of an acute bout of exercise can be utilized for a clear understanding of its influence pf physical activity on a chronic basis. Future efforts can be put towards the same.


 
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