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CTRI Number  CTRI/2018/04/013321 [Registered on: 17/04/2018] Trial Registered Prospectively
Last Modified On: 17/04/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of resistance training on cardiac autonomic control of Type 2 Diabetes Mellitus Patients 
Scientific Title of Study   Modulation of cardiac autonomic control by resistance training in Type 2 Diabetes Mellitus 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  M Ejaz Hussain 
Designation  Professor and Director 
Affiliation  Jamia Millia Islamia 
Address  Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, New Delhi, India
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia Jamia Nagar New Delhi
South
DELHI
110025
India 
Phone  9899339816  
Fax    
Email  ehusain@jmi.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  M Ejaz Hussain 
Designation  Professor and Director 
Affiliation  Jamia Millia Islamia 
Address  Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, New Delhi, India
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia Jamia Nagar New Delhi
South
DELHI
110025
India 
Phone  9899339816  
Fax    
Email  ehusain@jmi.ac.in  
 
Details of Contact Person
Public Query
 
Name  Pooja Bhati 
Designation  PhD Scholar 
Affiliation  Jamia MIllia Islamia 
Address  Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, New Delhi, India

South
DELHI
110025
India 
Phone    
Fax    
Email  pooja.bhati092@gmail.com  
 
Source of Monetary or Material Support  
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, New Delhi-110025, India 
 
Primary Sponsor  
Name  Centre for Physiotherapy and Rehabilitation Sciences 
Address  JAMIA MILLIA ISLAMIA, JAMIA NAGAR, NEW DELHI-25 
Type of Sponsor  Other [[CENTRAL UNIVERSITY]] 
 
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 
M Ejaz Hussain  Jamia Millia Islamia  Room no 2, Ground floor, PhD laboratory, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, New Delhi-110025, India
South
DELHI 
9899339816

ehusain@jmi.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Type 2 Diabetes Mellitus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control group  Participants in this group will receive conventional medical treatment of type 2 diabetes 
Intervention  Resistance Training  Participants in this group will perform whole body resistance exercises along with the conventional medical treatment of type 2 diabetes 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  59.00 Year(s)
Gender  Both 
Details  Type 2 Diabetes Mellitus patients with impaired cardiac autonomic control 
 
ExclusionCriteria 
Details  Type 2 Diabetes Mellitus patients involved in aerobic and resistance training for last 6 months

Type 2 Diabetes Mellitus patients with any severe cardiac disease

Type 2 Diabetes Mellitus patients with uncontrolled hypertension

Type 2 Diabetes Mellitus patients that are unable to follow directions and recognise symptom

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1) Measures of Cardiac autonomic control
2) Glycemic control
3) Metabolic control 
BASELINE
13TH WEEK 
 
Secondary Outcome  
Outcome  TimePoints 
Sleep quality
Blood lactate
Body composition
Muscle function
Muscle strength
Muscle fatigue
Quality of life
Well being
Biomarkers of endothelial function
Biomarkers of systemic inflammation
Vascular function 
BASELINE
13TH WEEK 
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
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)   01/05/2018 
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="1"
Days="1" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
Cardiac autonomic neuropathy (CAN) is a common yet overlooked complication of type 2 diabetes mellitus (T2DM). It has been found to be associated with various cardiovascular diseases and mortality but still there is lack of specific interventions targeting diabetic CAN. Exercise training has been shown be an effective adjunct therapy to modulate impaired cardiac autonomic control of T2DM patients, however, there is so far no study on the effect of resistance training (RT) on cardiac autonomic control of T2DM patients. Although neuromuscular benefits of RT are well established in scientific literature, there is no consensus on its cardiac autonomic effects. Therefore, the present study is a randomised, signle blinded, parallel group trial to ascertain the effects of RT on the cardiac autonomic control of T2DM patients. Apart from cardiac autonomic control, this study intends to investigate the effect of RT on biomarkers of systemic inflammation & endothelial function, glycemic & metabolic profile, muscle function, vascular function, blood lactate, body composition, quality of life, well-being and sleep quality of T2DM patients. This study is to be conducted at Jamia Millia Islamia. The patients will be recruited M A Ansari Health Centre, Jamia Millia Islamia. If came out with positive results, this study has the potential to help clinicians working with T2DM patients in formulating exercise protocols for optimal benefits.
 
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