| 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
|
|
|
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
|
|
|
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. |