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CTRI Number  CTRI/2024/05/066755 [Registered on: 03/05/2024] Trial Registered Prospectively
Last Modified On: 22/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Improving Workouts Using Bands to Boost Blood Flow in diabetic population 
Scientific Title of Study   Effect of blood flow restriction training on foot pain, disability and functional activities of daily living among diabetic adult population- 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  Dr Adarsh Kumar Singh 
Designation  PG students 
Affiliation  Galgotias University 
Address  Room No E003, Department of Physiotherapy, School of Allied Health Sciences, Galgotias University, Plot No 2, Sector 17A, Opposite Buddha international circuit, Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  9162469237  
Fax    
Email  adarshsingh005.as@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Adarsh Kumar Singh 
Designation  PG students 
Affiliation  Galgotias University 
Address  Room No E003, Department of Physiotherapy, School of Allied Health Sciences, Galgotias University, Plot No 2, Sector 17A, Opposite Buddha international circuit, Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  9162469237  
Fax    
Email  adarshsingh005.as@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mohammad Sidiq 
Designation  Associate Professor 
Affiliation  Galgotias University 
Address  Room No B-319, Department of Physiotherapy, School of Allied Health Sciences, Galgotias University, Plot No 2, Sector 17A, Opposite Buddha international circuit, Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  6006204628  
Fax    
Email  sidufatima@gmail.com  
 
Source of Monetary or Material Support  
Galgotias University, Room No A315, Plot No 2, Sector 17A, Opposite Buddha International circuit, Greater Noida, Gautam Buddha Nagar, Uttar Pradesh, Pin code 203201 
 
Primary Sponsor  
Name  Galgotias University 
Address  Room No C102, C Block, Plot No2, Sector 17A,opposite Buddha international Circuit, Greater Noida 
Type of Sponsor  Research institution 
 
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 Adarsh Kumar Singh  Galgotias University  Room No E003, Plot No 2, Sector 17A, Opposite Buddha international circuit, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH 		 9162469237

adarshsingh005.as@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Departmental 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 
Intervention  Blood flow restriction training  All patients diagnosed with foot pain will sign the informed consent. Demographic data, history and other data will be obtained at the baseline. The study will be done in accordance to the declaration of Helsinki. All patients will receive standard physiotherapy care. It will include therapy, foot isotonic exercises. The Experimental group will also receive BFR with single session with 75 vol LOP 40 to 50 % for toe curl exercise (moderate resistance) foot curls and foot flexion and extension using long leavers ankle. Follow up will be done for the patients on second visit after 8 weeks and long-term follow up after 6 months for others on phones who fail to come for follow up. All the patients will be explained about the possible benefits and complete procedure of the study and consent will be signed by each patient who is willing to participate in the study. They will be told its voluntary and they can withdraw anytime from the study and it won’t affect their treatment if they refuse to be part of the study. Patient information will be kept confidential. Each individual will serve as self-control to report about the possible benefit in pain score after receiving BFRT and after follow up. Total duration of the intervention will be 8 weeks. 
Comparator Agent  Standard Physiotherapy Care  All patients diagnosed with foot pain will sign the informed consent. Demographic data, history and other data will be obtained at the baseline. The study will be done in accordance to the declaration of Helsinki. All patients will receive standard physiotherapy care. It will include therapy, foot isotonic exercises. Resistance Dorsiflexion Ankle Training using therbands Resistant plantar flexion ankle training using therabands Total duration 2times per week for 8weeks  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Diabetic adults (Type 1 or Type 2).
Presence of foot pain, disability, or limitations in daily activities.
Stable medical condition without contraindications for exercise. 
 
ExclusionCriteria 
Details  Severe peripheral vascular disease.
Recent foot ulcerations or infections.
Inability to participate in exercise programs due to other medical conditions. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Foot function Index will be used to assess foot-related pain, disability, and activity limitations
The Barthel Index Wwill be used for assessing activities of daily living (ADL) 		 Baseline, 4 weeks and after 6 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
SF36 The SF-36 will be used to assess health-related quality of life  Baseline, 4 weeks and 6 weeks 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "55"
Final Enrollment numbers achieved (India)="55" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   15/05/2024 
Date of Study Completion (India) 04/07/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
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 - Researchers who provide a methodologically sound proposal.

  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 [adarshsingh005.as@gmail.com].

  6. For how long will this data be available start date provided 30-07-2024 and end date provided 30-07-2028?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NA
Brief Summary   This randomized controlled trial investigates the impact of blood flow restriction training on foot pain, disability, and functional activities of daily living in diabetic adults. Participants will be randomized into intervention and control groups, with the intervention group undergoing blood flow restriction training while the control group receives standard care. Outcome measures include foot pain intensity, disability using the Foot Function Index, and functional activities of daily living using the SF-36 Health Survey. The study aims to provide insights into the efficacy of blood flow restriction training in improving the quality of life and functional outcomes in diabetic individuals with foot complications. 
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