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CTRI Number  CTRI/2025/07/091958 [Registered on: 29/07/2025] Trial Registered Prospectively
Last Modified On: 25/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Development of supervised exercise training protocol and comparison with conventional exercises in asymptomatic peripheral arterial disease with type II diabetes mellitus patients on Ankle brachial index, HbA1c, functional capacity and quality of life 
Scientific Title of Study   Development of supervised exercise training protocol and comparison with conventional exercises in asymptomatic peripheral arterial disease with type II diabetes mellitus patients 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mayuri Shah 
Designation  Associate Professor 
Affiliation  Dr. D. Y. Patil College of Physiotherapy 
Address  Dr. D.Y.PATIL college of physiotherapy, Sant tukaram nagar, Pimpri Cardiopulmonary Department Out patient department

Pune
MAHARASHTRA
411018
India 
Phone  8087861628  
Fax    
Email  plkshah829@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Roopa Desai 
Designation  Professor 
Affiliation  Dr. D. Y. Patil College of Physiotherapy 
Address  Dr. D.Y.PATIL college of physiotherapy, Sant tukaram nagar, Pimpri Kinesiology and Movement science department 3rd floor

Pune
MAHARASHTRA
411018
India 
Phone  9890992383  
Fax    
Email  roopa.desai@dpu.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Roopa Desai 
Designation  Professor 
Affiliation  Dr. D. Y. Patil College of Physiotherapy 
Address  Dr. D.Y.PATIL college of physiotherapy, Sant tukaram nagar, Pimpri Kinesiology and Movement science department 3rd floor

Pune
MAHARASHTRA
411018
India 
Phone  9890992383  
Fax    
Email  roopa.desai@dpu.edu.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Mayuri R. Shah 
Address  Dr. D.Y. Patil College of Physiotherapy, Pimpri, Pune- 411018 
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 
Mayuri R Shah  Dr. D. Y. Patil College of Physiotherapy  Out patient department and Cardiopulmonary department
Pune
MAHARASHTRA 		 8087861628

plkshah829@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I70-I79||Diseases of arteries, arterioles and capillaries,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Supervised exercise training protocol  Supervised exercise training protocol will be designed and validated using delphi method. Post validation the protocol will be supervised and will include warm up exercises, stretching of major muscles, aerobic exercises, resistance exercises with duration starting with 30 minute session in first week to 45 minute session in twelfth week. Session will be carried for 3 alternate days per week. 
Comparator Agent  Walking and Buergers exercises  Walking on flat surface for 15 min per session in first week proceeding to 45 min in twelfth week. Session will be given for 3 alternate days per week. Since patients will be asymptomatic progression will be based on rate of perceived exertion using borg scale. Buergers exercises will be given in 3 positions namely elevation, dependent and horizontal. Patients will perform these exercises 3 times a day with 3-6 cycles per maneuver. 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Patients diagnosed by diabetologist with Type II Diabetes Mellitus for more than or equal to 10 years and who will be asymptomatic for symptoms of Peripheral arterial disease
2.Score of 6.5 percent to 11 percent of HbA1C
3.Score of less than 6 on Rapid assessment of Physical Activity
4.Score of 0.5 to less than or equal to 0.9 on 5.Ankle Brachial Index
6.Patients if diagnosed with OA knee, Score on Numeric Pain Rating Scale less than or equal to 3
 
 
ExclusionCriteria 
Details  1.Patient following any kind of exercise regime like going to gym, yoga etc.
2.Patient having addiction of smoking, tobacco, and alcohol intake
3.Patients already having complications like diabetic foot ulcer, amputation, neuropathy with renal failure and symptoms of claudication
4.Known Cardiopulmonary disorders like Bronchial Asthma, COPD, Myocardial Ishchemia, Angina, Coronary artery disease
5.Patients on Anticoagulants 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Ankle Brachial Index
2. HbA1c 		 1. Pre treatment
2. After 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1. 6 minute walk distance
2. SF 36 		 1. Pre treatment
2. After 12 weeks 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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 
Date of First Enrollment (India)   15/09/2025 
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="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  
People with type 2 diabetes should engage in physical activity regularly and be encouraged to reduce sedentary time and break up sitting time with frequent activity breaks according to ACSM criteria 2022. Asymptomatic PAD remains the most common presentation of the disease. The detailed clinical history, physical changes in the lower leg skin, and examination of peripheral pulses can provide clues to the diagnosis. For decades, exercise has been considered a cornerstone of diabetes management, along with diet and medication.

However, high-quality evidence on the importance of exercise and fitness in diabetes was lacking until recent years. Exercise can directly improve physiological function by reducing blood glucose levels, increasing stamina and emotional well-being and increasing circulation. Peripheral artery disease is independently associated with impaired function, an increased risk of mortality, and decreased quality of life. 

RESEARCH GAP:

1. Lack of standardized protocol for asymptomatic Peripheral arterial disease with Type II diabetes mellitus patients.

2. Lack of Randomized control trials in evaluating the efficacy of supervised exercises in asymptomatic Peripheral arterial disease with Type II diabetes mellitus patients.

3. Need for outcome-based trials to determine if Supervised Exercise Training protocol offers vascular protection in asymptomatic Peripheral arterial disease with Type II diabetes mellitus patients.

4. Research needed to evaluate outcomes of early Supervised Exercise Training protocol based on  Ankle Brachial Index (ABI) screening in diabetes care.

5. A lack of Supervised Exercise Training protocol designed for early-stage asymptomatic Peripheral arterial disease for prevention of further complications due to Type II diabetes mellitus.

 
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