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CTRI Number  CTRI/2023/11/060077 [Registered on: 21/11/2023] Trial Registered Prospectively
Last Modified On: 07/11/2023
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 exercise on heart function in type 2 diabetes mellitus  
Scientific Title of Study   Effect of exercise training on cardiac autonomic function and left ventricular mass index in type 2 diabetes mellitus with cardiac autonomic neuropathy 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sohini Shailesh Raje 
Designation  PhD Scholar 
Affiliation  Manipal Academy of Higher Education 
Address  Centre for Podiatry and Diabetic Foot Care and Research, Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8879625591  
Fax    
Email  sohini.mchpmpl2022@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Sohini Shailesh Raje 
Designation  PhD Scholar 
Affiliation  Manipal Academy of Higher Education 
Address  Centre for Podiatry and Diabetic Foot Care and Research, Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8879625591  
Fax    
Email  sohini.mchpmpl2022@learner.manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr G Arun Maiya 
Designation  Dean- Manipal College of Health Professions; Professor- Department of Physiotherapy 
Affiliation  Manipal Academy of Higher Education 
Address  Centre for Podiatry and Diabetic Foot Care and Research, Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9845350823  
Fax    
Email  arun.maiya@manipal.edu  
 
Source of Monetary or Material Support  
Centre for Podiatry and Diabetic Foot Care and Research, Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal-576104, Karnataka 
 
Primary Sponsor  
Name  Human Resource Development Group- Council of Scientific Research 
Address  Council of Scientific and Industrial Research, Anusandhan Bhawan, 2 Rafi Ahmed Kidwai Marg, New Delhi- 110001 
Type of Sponsor  Government funding agency 
 
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 G Arun Maiya  Kasturba Hospital  Centre for Podiatry and Diabetic Foot Care and Research, Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA 		 9845350823

arun.maiya@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Manipal Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control   Standard Protocol- Standard Physician care and education about routine physical activity, diabetes and heart 
Intervention  Exercise   Standard Physician Care Education about routine physical activity, diabetes and heart. Exercise program will consist of aerobic exercises (walking, jogging, cycling, swimming), resistance exercises (Lower limb & upper limb strengthening, abdominal strengthening) and flexibility/stretching exercises. Participants will be asked to follow exercise program for 3-5 days per week for 12 weeks (Week1-2- Supervised; Week 3- 12- Virtually supervised). After 12 weeks, the participants are asked to follow the same exercise protocol to check maintenance. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  - Individuals with type 2 diabetes mellitus with cardiac autonomic neuropathy 
 
ExclusionCriteria 
Details  -Type 1 diabetes mellitus, gestational diabetes mellitus and other genetic forms.
-Presence of underlying conditions- Rheumatic heart disease, recent myocardial infarction, coronary artery bypass graft, heart failure, abdominal surgery in past 3 months, end stage renal disease, acute kidney injury, diabetic foot ulcers, severe systemic disease, any systemic neuromuscular disorder, any orthopedic surgery in past 6 months or injury limiting participation in exercise
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Cardiac autonomic function and left ventricular mass index  Cardiac autonomic function at 3 time points- baseline, 12th week and 24th week

left ventricular mass index at 2 time points- baseline and 24th week 
 
Secondary Outcome  
Outcome  TimePoints 
Heart rate variability, glycemic parameters, functional capacity, quality of life  Heart rate variability, functional capacity, quality of life at 3 timepoints- baseline, 12th week and 24th week

Glycemic parameters at 2 timepoints- baseline and 24th week 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
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 4 
Date of First Enrollment (India)   01/12/2023 
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="3"
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   The study is randomized controlled trial in individuals with type 2 diabetes mellitus with cardiac autonomic neuropathy, between ages 40 to 65 years of any gender. Participants with type 2 diabetes mellitus will be screened for cardiac autonomic neuropathy (CAN) using Cardiac Autonomic Reflex Tests (Ewing’s battery of 5 tests). Participants falling in the inclusion will be informed about the study and written informed consent will be taken. Baseline assessments of cardiac autonomic function (using cardiac autonomic reflex tests) left ventricular mass index (2D Echocardiography), heart rate variability, glycemic parameters, functional capacity (6-minute walk test) and quality of life (WHO QOL-BREF Questionnaire).  Participants will be randomized into intervention group (Standard care, routine physical activity education, exercise training) and control group (Standard care and routine physical activity education). The intervention will be for the duration of 12 weeks- consisting of aerobic, resistance and flexibility exercises. First 2 weeks of intervention will be supervised followed by a virtually supervised exercise program (using a validated digital application). After 12 weeks, cardiac autonomic function, heart rate variability, functional capacity and quality of life will be assessed in all participants. At 24th week (maintenance phase), all outcomes assessed at baseline will be reassessed in all participants. 
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