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CTRI Number  CTRI/2024/07/070544 [Registered on: 13/07/2024] Trial Registered Prospectively
Last Modified On: 12/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Impact of blood flow restriction training on lower limb muscle strength along with blood glucose level and lipid profile in type 2 diabetes patients.  
Scientific Title of Study   EFFECTS OF BLOOD FLOW RESTRICTION TRAINING ON QUADRICEPS MUSCLE STRENGTH AND BIOCHEMICAL PARAMETERS AMONG INDIVIDUALS WITH TYPE 2 DIABETES MELLITUS: A RANDOMIZED CONTROLLED TRIAL 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Arghya Mondal 
Designation  Master of Physiotherapy Student 
Affiliation  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation 
Address  B-31/6, Cardiopulmonary Physiotherapy Research Lab
Maharishi Markandeshwar(Deemed to be University), Mullana-Ambala, Haryana, India Pin 133207
Ambala
HARYANA
133207
India 
Phone  9748881715  
Fax    
Email  arghyamondal1809@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mandeep Kumar Jangra 
Designation  Assistant Professor 
Affiliation  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation 
Address  B-31/6, Cardiopulmonary Physiotherapy Research Lab
Maharishi Markandeshwar(Deemed to be University), Mullana-Ambala, Haryana, India Pin 133207
Ambala
HARYANA
133207
India 
Phone  9416797708  
Fax    
Email  mandeep.jangra@mmumullana.org  
 
Details of Contact Person
Public Query  
Name  Dr Mandeep Kumar Jangra 
Designation  Assistant Professor 
Affiliation  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation 
Address  B-31/6, Cardiopulmonary Physiotherapy Research lab
Maharishi Markandeshwar(Deemed to be University), Mullana, Ambala, Haryana, India Pin 133207
Ambala
HARYANA
133207
India 
Phone  9416797708  
Fax    
Email  mandeep.jangra@mmumullana.org  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Arghya Mondal 
Address  Maharishi Markandeshwar institute of physiotherapy and rehabilitation Maharishi Markandeshwar deemed to be university 
Type of Sponsor  Other [Self] 
 
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 Mandeep Kumar Jangra  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation  Room No. B-31/6, Cardiopulmonary Research Lab, Department of Physiotherapy
Ambala
HARYANA 		 9416797708

mandeep.jangra@mmumullana.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Maharishi Markandeshwar Institute of Medical Sciences and Research  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  Blood flow restriction training utilizes the partial restriction of blood flow to the muscles being exercised by applying an inflatable cuff. Protocols for lower extremity exercises are leg extension, leg curl, straight leg raise hip flexion. Leg extension is performed with long sitting, leg curl is performed with prone lying, and straight leg raising is performed with supine lying position. Protocols for upper extremity exercises are arm extension and arm curl. Both upper limb exercises are performed with long standing position. Frequency for both lower limb and upper limb exercises is 4 sets with 30,15,15,15 reps, 3 days in a week, and 4 weeks protocol. Warm-up and cool-down exercises are performed before and after the intervention. 
Comparator Agent  Resistance Training  Resistance training is referred to as strength training is a progressive use of varying loads, movements, and velocities to gain muscle mass & strength. Exercise protocols with resistance band for the upper extremity are rowing, standing bench press, and arm curl, and for lower limb are knee extension, knee flexion, and forward walking with 75% of 1 RM intensity. Frequency is 3 sets of 10 reps each, 30-sec intervals, 3 days in a week, and 4 weeks protocol. Warm-up and cool-down exercises are performed before and after exercises. 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Atleast 2 years history of Type 2 Diabetes
HBA1C more than 6
Non Smoker & Non Alcoholic 
 
ExclusionCriteria 
Details  Respiratory problem,
Severe complications of diseases(peripheral diabetic neuropathy, cardiovascular, renal, visual, cerebral)
Neurological disorders,
Musculoskeletal disorders 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Quadriceps muscle strength,
Haemoglobin A1c,
Low-density lipoproteins, High-density lipoproteins, Very low-density lipoproteins, Triglycerides, Total cholesterol 		 Baseline & After intervention of 4 weeks (3 days per week) 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="58"
Sample Size from India="58" 
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 2/ Phase 3 
Date of First Enrollment (India)   23/07/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  23/07/2024 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [arghyamondal1809@gmail.com].

  6. For how long will this data be available start date provided 30-04-2025 and end date provided 30-04-2028?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Blood flow restriction training (BFRT) involves partially occluding blood flow to exercising muscles, offering a promising alternative for individuals with type 2 diabetes. This study aims to compare BFRT with resistance training in improving quadriceps strength and biochemical parameters in individuals with type 2 diabetes. Participants will be randomly assigned to either BFRT or resistance training groups for 4 weeks. Outcome measures include quadriceps strength, HbA1C, and lipid profiles. BFRT may offer effective muscle strengthening and metabolic benefits for individuals with type 2 diabetes.
Patients will be recruited after getting CTRI registration no.
 
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