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CTRI Number  CTRI/2025/08/092499 [Registered on: 06/08/2025] Trial Registered Prospectively
Last Modified On: 07/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   A study to compare the effect of mild blood flow restriction in limbs with exercise vs exercise without blood flow restriction on blood sugar levels in diabetic people 
Scientific Title of Study   The Impact of Blood Flow Restriction Training Combined with Low to Moderate Intensity Exercise versus Traditional Exercise on Glycemic Control in Individuals with Type 2 Diabetes Mellitus.”– An Experimental Study  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Alex Collins Mathew 
Designation  Student 
Affiliation  Sri Ramachandra Institute Of Higher Education and Research (DU) 
Address  Department of Physiotherapy Division of Cardiopulmonary Physiotherapy Sri Ramachandra Institute of Higher Education and Research (Deemed to be University) No. 1, Ramachandra Nagar, Porur Chennai – 600116, Tamil Nadu, India

Chennai
TAMIL NADU
600116
India 
Phone  7223904655  
Fax    
Email  t0121065@sriher.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Ajith Kumar P 
Designation  Lecturer 
Affiliation  Sri Ramachandra Institute Of Higher Education and Research (DU) 
Address  Department of Physiotherapy Division of Cardiopulmonary Physiotherapy Sri Ramachandra Institute of Higher Education and Research (Deemed to be University) No. 1, Ramachandra Nagar, Porur Chennai – 600116, Tamil Nadu, India

Chennai
TAMIL NADU
600116
India 
Phone  9087350257  
Fax    
Email  ajithkumarp@sriramachandra.edu.in  
 
Details of Contact Person
Public Query
 
Name  Alex Collins Mathew 
Designation  Student 
Affiliation  Sri Ramachandra Institute Of Higher Education and Research (DU) 
Address  Department of Physiotherapy Division of Cardiopulmonary Physiotherapy Sri Ramachandra Institute of Higher Education and Research (Deemed to be University) No. 1, Ramachandra Nagar, Porur Chennai – 600116, Tamil Nadu, India

Chennai
TAMIL NADU
600116
India 
Phone  7223904655  
Fax    
Email  t0121065@sriher.edu.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Alex Collins Mathew 
Address  Sri Ramachandra Institute Of Higher Education and Research (DU) 
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 
Alex Collins Mathew  Sri Ramachandra Institute Of Higher Education and Research (DU)  Outpatient Department of physiotherapy Ground Floor division of cardiopulmonary physiotherapy
Chennai
TAMIL NADU 
7223904655

t0121065@sriher.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee Sri Ramachandra Institute of Higher Education & Research Porur, Chennai - 600116  Approved 
Institutional Ethics Committee Sri Ramachandra Institute of Higher Education & Research Porur, Chennai - 600116  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  Blood Flow Restriction Training with Low to Moderate Intensity Exercise  Participants will undergo supervised blood flow restriction (BFR) training using elastic cuffs on the proximal thigh. Exercises will include low to moderate intensity lower limb resistance and aerobic activities for 3 sessions per week over a period of 8 weeks. BFR pressure will be individually calibrated. The exercise protocol includes warm-up, resistance training (e.g., leg extensions, squats), and aerobic walking or cycling. Session duration: approximately 30–45 minutes.  
Comparator Agent  Traditional Low to Moderate Intensity Exercise  Participants will perform traditional low to moderate intensity exercise without blood flow restriction. This includes resistance and aerobic training, 3 sessions per week for 8 weeks. Exercises include leg presses, bodyweight squats, and treadmill walking or stationary cycling. Each session will last for 30–45 minutes, matching the BFR group in duration and structure.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  The study includes individuals with type 2 diabetes mellitus, both males and females, aged between 18 and 55 years. Participants must have provided consent and have a glycated hemoglobin (HbA1c) level between 7 and 10.
 
 
ExclusionCriteria 
Details  Individuals with a history of certain medical conditions are excluded, including cerebrovascular accident (CVA), chronic kidney disease (CKD), coronary artery disease (CAD), heart failure, and uncontrolled hypertension. Additionally, those with musculoskeletal impairment, peripheral vascular disease (PVD), deep vein thrombosis (DVT), or thromboembolic events are not eligible. Patients with severe neuropathy, sensory deficits, open wounds, skin infections, or compromised skin integrity in the limb undergoing blood flow restriction training (BFRT) are also excluded. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Glycated Hemoglobin (HbA1c), Fasting Blood Sugar( FBS)  Baseline (Pre-intervention)
8 Weeks (Post-intervention) 
 
Secondary Outcome  
Outcome  TimePoints 
Handgrip Strength (HGS)
Diabetes-Specific Quality of Life Questionnaire (DM-QOL) 
Baseline (Pre-intervention)
8 Weeks (Post-intervention) 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   18/08/2025 
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="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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
Modification(s)  

A experimental trial is planned to be conducted at the Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research (Deemed to be University). An informed consent will be obtained from the study population. The Individuals glycemic levels, quality of life and muscle strength are to be measured, using HbA1c, QoL-Q Diabetes and Hand-Held Dynamometer respectively. The study population will be allocated into two groups, the experimental group and the control group. The experimental group will undergo BFRT with low to moderate intensity exercise whereas the control group will undergo same exercise regimen without the application of BFRT. The intervention will run for eight weeks with outcome measures assessed both at baseline (pre-intervention) and after completion of the exercise program (post-intervention). The participants in the experimental group will be made to perform Blood Flow Restriction training BFRT that will target the upper limbs using compound resitstance exercises such as seated rows, upright rows and shoulder presses while a BFRT cuff inflated to 40% of arterial occlusion pressure (AOP) is applied over the proximal portion of both upper arms. The exercise performed will consist of 3 sets of 30 seconds (continuos repititions) with rests between each set of 30 seconds. The cuff will remain inflated for the entireity of the exercise, The total occlusion time per exercise will be 3 minutes and after completion of 3 sets in an exercise, the cuffs will be deflated and participants will be allowed to rest for 1-3 minutes to allow for vascular reperfusion before proceeding to the next exercise. AOP will be measured for each individual using either Doppler Ultrasound or standardized palpatory methods.

 
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