| 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
|
|
|
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
|
|
|
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
|
|
|
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. |
|
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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. |