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CTRI Number  CTRI/2024/07/070192 [Registered on: 08/07/2024] Trial Registered Prospectively
Last Modified On: 07/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Single Arm Study 
Public Title of Study   To see effects of strength and aerobics combined exercise training in children with Juvenile Diabetes Mellitus on Glucose control and improving Quality of life 
Scientific Title of Study   Effectiveness of Concurrent Resistance and Aerobic Exercise on Glycaemic Control and Quality of Life in Juvenile Diabetes Children 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Lavanya D 
Designation  PG student 
Affiliation  SDM COLLEGE OF PHYSIOTHERAPY 
Address  OPD No 13, Paediatrics Physiotherapy OPD, SDM Hospital, Sattur, Dharwad

Dharwad
KARNATAKA
580009
India 
Phone  8861885287  
Fax    
Email  lavanyaad.2000.28@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sanjay Parmar 
Designation  Professor, PG Guide, Principal of SDM College of Physiotherapy 
Affiliation  SDM COLLEGE OF PHYSIOTHERAPY 
Address  SDM College of Physiotherapy, Sattur, Dharwad

Dharwad
KARNATAKA
580009
India 
Phone  9845340450  
Fax    
Email  sanjaytparmar777@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Lavanya D 
Designation  PG student 
Affiliation  SDM COLLEGE OF PHYSIOTHERAPY 
Address  OPD No 13, Paediatrics Physiotherapy OPD, SDM Hospital, Sattur, Dharwad

Dharwad
KARNATAKA
580009
India 
Phone  8861885287  
Fax    
Email  lavanyaad.2000.28@gmail.com  
 
Source of Monetary or Material Support  
OPD No 13, Paediatrics Physiotherapy OPD, SDM Hospital, Sattur, Dharwad, Karnataka 580009 
self funded  
 
Primary Sponsor  
Name  Lavanya D  
Address  SDM College of Physiotherapy, Manjushree Nagar, Sattur, Dharwad 
Type of Sponsor  Other [Self funding ] 
 
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 Sanjay Parmar   SDM hospital   OPD No 13, Paediatrics Physiotherapy OPD, SDM Hospital, Sattur, Dharwad, Karnataka 580009
Dharwad
KARNATAKA 
9845340450

sanjaytparmar777@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC-SDM College sciences and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E109||Type 1 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  concurrent resistance and aerobics exercise  concurrent resistance and aerobics exercise for 45-60 mins, 3 session a week followed up for 8 weeks  
Comparator Agent  NOT APPLICABLE  NOT APPLICATION 
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  Confirmed Juvenile diabetes mellitus in paediatric population
Patients falling in the age group of 8 years to 16 years of either gender
Duration of diabetes for at least one year or over
Glycated haemoglobin (HbA1c) more than 7 percentile
Patients on insulin therapy (on Multiple dose injections Basal Bolus regimen)
Patients willing to participate 
 
ExclusionCriteria 
Details  Non-willing parent not given consent
Patients with cardiovascular risk
uncontrolled diabetes
Severe hypoglycaemia
Other systemic disorders like Cushings disease and on steroid usage
Diabetic Retinopathy Neuropathy Nephropathy
Morbid obesity 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Glycated haemoglobin (HbA1c)
Fasting blood sugar
Post prandial blood sugar
Random blood sugar
Daily total insulin dose
Number of hypoglycaemic events 
At baseline and after 8 weeks of intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Peds QL (Diabetes Module) scale
Peds QL (Generic core) scale 
At baseline & after 8 weeks of intervention 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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   Phase 3 
Date of First Enrollment (India)   22/07/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   Juvenile diabetes is a chronic metabolic disorder characterized by high plasma levels of glucose resulting from defect in insulin secretion, insulin action, or both. In juvenile DM autoantibodies of oneself attack Beta cells of pancreas which inhibits the synthesis of insulin from pancreas. Type 1 / Juvenile DM is a insulin dependent DM where there is absolute or no insulin production caused by autoimmune beta cell destruction in the pancreas. It usually occurs in children or adolescents therefore it is named as Juvenile DM When the glycemia is not under control children experience severe complication like Diabetic ketoacidosis, diabetic neuropathy, nephropathy, retinopathy, heart and blood vessel diseases.
Exercise has a direct positive effect on glycaemic control by promoting insulin secretion from beta pancreatic cells and by increasing skeletal muscle glucose uptake. Exercise promotes glucose uptake both acutely and overtime through the contraction mediated and insulin stimulated pathways therefore moderate to vigorous daily exercises can improve blood glucose management in patients with Juvenile DM Many families do not follow the recommendations that children and adolescents should spend in 60min or more of physical activity daily. Majority of young adults do not achieve physical fitness goals, especially in juvenile diabetes children there are many contributing factors like maintaining stable blood glucose levels before during and after exercise and also the fear of hypoglycaemia, therapist can play an important role in assisting families with these challenges as physical activity benefits with managing diabetes by improving glycaemic control, general health management and psychological well being.
Previous clinical trials have been conducted which provide evidence regarding the effectiveness of concurrent training for duration ranging from 12 weeks up to 32 weeks and these studies did not encourage overall body training. As there are no supporting studies which have intervened exercise prescription for children with juvenile diabetes in Karnataka and India, hence the purpose of the study arises to study the effectiveness of concurrent resistance and aerobics training using Peds QL Diabetes Module for a period of 8 weeks in children aged between 8 to 16 years with Juvenile diabetes while monitoring their glucose throughout the intervention under the supervision of a registered medical practitioner and to see the improvement in quality of life of juvenile diabetic population. This study can encourage physical activity in children with T1DM and improve the quality of living with the disease.
 
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