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CTRI Number  CTRI/2021/04/032785 [Registered on: 13/04/2021] Trial Registered Prospectively
Last Modified On: 18/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Does physical exercise have an effect on fitness and quality of life in adults with Epilepsy. 
Scientific Title of Study   Effect of Physical Exercise on Fitness and Quality of Life in Adults with Epilepsy 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Geeta Devendra Bhatt 
Designation  PhD Scholar 
Affiliation  K. J. Somaiya College of Physiotherapy 
Address  Ground Floor, Department of Neurophysiotherapy, Neuro OPD, K. J. Somaiya College of Physiotherapy, Somaiya Ayurvihar Complex, Chunabhatti, Sion, Mumbai
Ground Floor, Department of Neurophysiotherapy, Neuro OPD,Somaiya Ayurvihar Complex, Chunabhatti, Sion, Mumbai.
Mumbai (Suburban)
MAHARASHTRA
400022
India 
Phone  9323275268  
Fax    
Email  geeta.bhatt@somaiya.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Lata Parmar 
Designation  Professor and Head 
Affiliation  College of Physiotherapy,  
Address  Ground Floor, Principals Office, College of Physiotherapy,Sumandeep Vidyapeeth, At and Po. Pipariya, Waghodia
Ground Floor, Principals Office, College of Physiotherapy,Sumandeep Vidyapeeth, At and Po. Pipariya, Waghodia
Vadodara
GUJARAT
391760
India 
Phone  9825825578  
Fax    
Email  principal.physiotherapy@sumandeepvidyapeethdu.edu.in  
 
Details of Contact Person
Public Query  
Name  Geeta Devendra Bhatt 
Designation  PhD Scholar 
Affiliation  K. J. Somaiya College of Physiotherapy 
Address  Ground Floor, Department of Neurophysiotherapy, Neuro OPD, K. J. Somaiya College of Physiotherapy, Somaiya Ayurvihar Complex, Chunabhatti, Sion, Mumbai
Ground Floor, Department of Neurophysiotherapy, Neuro OPD, K. J. Somaiya College of Physiotherapy, Somaiya Ayurvihar Complex, Chunabhatti, Sion, Mumbai.
Mumbai (Suburban)
MAHARASHTRA
400022
India 
Phone  9323275268  
Fax    
Email  geeta.bhatt@somaiya.edu  
 
Source of Monetary or Material Support  
K. J. Somaiya Medical College and Research Centre.  
 
Primary Sponsor  
Name  Geeta Devendra Bhatt 
Address  K. J. Somaiya Medical College and Research Centre, Somaiya Ayurvihar Complex, Everard Nagar, Eastern Express Highway, Chunabhatti, Sion, Mumbai- 400 022, Maharashtra 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Sumandeep Vidyapeeth   Sumandeep Vidyapeeth, At & Po. Pipariya, Ta. Waghodia, Dist. Vadodara, Gujarat- 391760 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Geeta Bhatt  Exercisse Physical Fitness Lab, K J Somaiya College of Physiotherapy  Department of Physiotherapy, Ground Floor, Dept of Physiotherapy,K J Somaiya College of Physiotherapy, Ayurvihar Complex, Chunabhatti, Sion, Mumbai
Mumbai (Suburban)
MAHARASHTRA 		 9323275268

geeta.bhatt@somaiya.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sumandeep Vidyapeeth Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G998||Other specified disorders of nervous system in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Effect of Physical Exercise on fitness and quality of life in patients with and without epilepsy  Both the control as well as the epileptic group would be given exercises comprising of stretching, warm up, aerobic exercises and cool down exercises for a total duration of 30 minutes, 3 times a week for a period of 6 months. 
Intervention  Physical Exercises  Aerobic Exercises which will also include stretching, warm up and cool down exercises. These exercises will be conducted for 30 minutes per session, 3 sessions per week for a span of 6 months. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Non Institutionalized Idiopathic Focal or Generalized Epilepsy, seizure free since the past 6 months, ambulatory and Physically active 
 
ExclusionCriteria 
Details  Any acute and chronic illness (including neurological disorders
other than epilepsy)

• Any Injury

• Previous surgery

• Use of pace makers

• Pregnancy

• Chronic or inflammatory diseases like diabetes mellitus, thyroid dysfunction
• Major congenital malformations
• cancer
• Individuals who are already exercising on a regular basis

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Shuttle Walk Test, WHO QOL BREF, and IPAQ Questionnaire  baseline during beginning of study on day 1, after 4 weeks, 3 months and 6 months. 
 
Secondary Outcome  
Outcome  TimePoints 
Vo2 Max  6 months 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/04/2021 
Date of Study Completion (India) 13/10/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 13/10/2022 
Estimated Duration of Trial   Years="0"
Months="6"
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)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [geeta.bhatt@somaiya.edu].

  6. For how long will this data be available start date provided 30-01-2021 and end date provided 30-01-2022?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  
 To study and compare the effect of physical exercise on fitness and quality of life in adults with and without epilepsy. To measure the integrated response of multiple cardiopulmonary and musculoskeletal systems involved in exercise using the Shuttle Walk test and VO2 Max in adults with epilepsy. to study and assess the Quality of life in adults with epilepsy using the WHO- QOL BREF and IPAQ Questionnaire. To measure the integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise using the shuttle walk test and VO2 Max in adults without epilepsy( Control Group). To study and assess the Quality of Life in adults without epilepsy ( Control group)using WHO QOL BREF and IPAQ Questionnaire. To compare the fitness and quality of life of adults with epilepsy with the control group consisting of adults without epilepsy.
HYPOTHESIS:
Null Hypothesis:
1. There is no significant difference in effect of physical exercise on fitness in adults with epilepsy and without epilepsy.
2. There is no significant difference in effect of physical exercise on quality of life in adults with and without epilepsy.

Alternate Hypothesis:
1. There is a significant difference in effect of physical exercise on fitness in adults with and without epilepsy.
2. There is a significant difference in effect of physical exercise on quality of life in adults with and without epilepsy.
 
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