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CTRI Number  CTRI/2024/09/074350 [Registered on: 25/09/2024] Trial Registered Prospectively
Last Modified On: 20/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Measurement of fitness measures and effect of continuous ,fast running in Diabetic Population  
Scientific Title of Study   Assessment of Physical Fitness Parameter And Effect of Fartlek Training in Person With Type -2 Diabetes – Mixed Method Study. 
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 Dwija Yagnik 
Designation  Assistant Professor  
Affiliation  PARUL INSTITUTE OF PHYSIOTHERAPY ,PARUL UNIVERSITY 
Address  Parul Institute Of Physiotherapy ,Limda ,Waghodia ,Vadodara -391760
Parul Institute Of Physiotherapy ,Limda ,Waghodia ,Vadodara -391760
Vadodara
GUJARAT
391760
India 
Phone  9909021553  
Fax    
Email  dwija2988@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bhavna Gadhavi 
Designation  Dean and Principal 
Affiliation  PARUL INSTITUTE OF PHYSIOTHERAPY ,PARUL UNIVERSITY 
Address  Parul Institute Of Physiotherapy, Limda , Waghodia, Vadodara-391760
Parul Institute Of Physiotherapy, Limda , Waghodia, Vadodara-391760
Vadodara
GUJARAT
391760
India 
Phone  9773256412  
Fax    
Email  bhavana.gadhavi28222@paruluniversity.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Bhavna Gadhavi 
Designation  DEAN & PRINCIPAL 
Affiliation  PARUL INSTITUTE OF PHYSIOTHERAPY ,PARUL UNIVERSITY 
Address  Parul Institute of Physiotherapy ,Limda ,Waghodia, Vadodara-391760
Parul Institute of Physiotherapy ,Limda ,Waghodia, Vadodara-391760
Vadodara
GUJARAT
391760
India 
Phone  9773256412  
Fax    
Email  bhavana.gadhavi28222@paruluniversity.ac.in  
 
Source of Monetary or Material Support  
Parul Sevashram Hospital Room no 220 ,Second floor, Department of Physiotherapy Parul Sevashram Hospital, Parul University, p.o. Limda Waghodia Vadodara- 391760 Gujarat India  
 
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 
DrDwija Yagnik  Parul Sevashram Hospital  Parul Sevashram Hospital room no.220 department of physiotherapy
Vadodara
GUJARAT 		 9909021553
391760
dwija2988@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Parul University Institutional Ethics Committee For Human Research   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Fartlek training  total 5 weeks protocol(4 days per week) Duration - 30 minutes No repetations - 3  
Comparator Agent  Walking  Total 5 weeks protocol Duration - 4 days per week 
 
Inclusion Criteria  
Age From  44.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  All subjects with pre-diagnosed of T2 –DM
Both male and female participants will be included.
Subjects with middle age group 44-60yrs
Subjects willing to participate.
Subjects not included in any other study in the past year.
 
 
ExclusionCriteria 
Details  Subjects with recent injuries
Subjects having Sensory Loss/ symptoms of Diabetic Neuropathy
Subjects diagnosed with any Cardiovascular and Respiratory illness.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
6 minute walk test  5 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
SF36 Quality of life  5 weeks 
 
Target Sample Size   Total Sample Size="94"
Sample Size from India="94" 
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)   23/10/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  23/10/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
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   AIM- To find out effect of fartlek training on affected parameters of phase one in middle aged individual  with type II diabetes.
INTRODUCTION - The burden of diabetes is high and increasing globally, and in developing economies like India, mainly fueled by the increasing prevalence of overweight/obesity and unhealthy lifestyles. A reduction in daily physical activity may result in obesity and insulin resistance, which are important components of metabolic syndrome. This syndrome predicts an increased risk of developing type 2 diabetes mellitus (T2DM) and cardiovascular diseases, as well [2] Exercise has significant effects on the metabolism of nutrients. It diminishes the blood glucose levels and plays an important role in the treatment of patients with diabetes. Regular exercise may improve glycemic control, reduce cardiovascular risk factors, play a role in weight loss and, consequently, improve well-being among these patients.[4]Fartlek, which means "speed play" in Swedish, is a training method that blends continuous training with interval training. Fartlek runs are a very simple form of a long-distance run. Fartlek training “is simply defined as periods of fast running intermixed with periods of slower running."[7] The aerobic, anaerobic, and anaerobic system gets activated due to fluctuations in intensity and pace.[8] Studies have shown that Maximum oxygen consumption is reduced due to obesity as there is decreased body metabolism .Studies have also suggested that VO2 max is reduced in obese population. There is lack of evidence that show effect of Fartlek training in non-athletic young population. Fewer literatures have shown effect of Fartlek training on maximum oxygen consumption in obese type 2 diabetic population.[8]
NEED OF THE STUDY - â€¢       
There are multiple protocols have been given to these patients for the different physical activities. Though there are various training protocols, a confirmatory effective training method that gives an idea about how much intensity and time duration of a particular exercise is needed to be performed daily is a still debatable topic. So here this study will help to get more prescribed exercise protocol and this study will help to find out a single protocol that enhances the overall metabolism in diabetes patients.
•        Most of the studies for the fartlek training are done on the athletic population. So, there is a need for a study that can help to find out the different aspects of health benefits of fartlek training in type-2 diabetic population for their regular physical activities
PROCEDURE - After taking approval from ctri and ethical committee informed consent will be taken from the patients and pre and post assessment done according to the inclusion criteria. Participants will be divided into two groups in Group A will receive Fartlek training and group B Walking for 5 weeks and post assessment will be taken after 5 weeks conclusion of the study will be made after statistical analysis.
 

 
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