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CTRI Number  CTRI/2024/03/063667 [Registered on: 06/03/2024] Trial Registered Prospectively
Last Modified On: 05/03/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Benefits of exercise on blood sugar level post exercises 
Scientific Title of Study   Effect of resistance exercise on blood glucose level in patient with type 2 diabetes mellitus  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prachi Thorat 
Designation  Intern 
Affiliation  Dr Apj Abdul Kalam College Of Physiotherapy 
Address  Dr Apj Abdul Kalam College Of Physiotherapy Loni Pravara Institute of Medical Sciences. Department of orthopedic physiotherapy OPD no.403 Loni Maharashtra

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  8828143929  
Fax    
Email  prachithorat0077@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sukhpreet Pabla 
Designation  Assistant Professor 
Affiliation  Dr Apj Abdul Kalam College Of Physiotherapy 
Address  Pravara Institute Of Medical Sciences. Dr Apj Abdul Kalam College Of Medical Sciences. Orthopaedic Physiotherapy Opd Tal Rahata District Ahmednagar Loni Maharashtra

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  9638299273  
Fax    
Email  pablasukhpreet27@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Prachi Thorat 
Designation  Intern 
Affiliation  Dr Apj Abdul Kalam College Of Physiotherapy 
Address  Dr Apj Abdul Kalam College Of Physiotherapy Loni Department of Orthopedic physiotherapy OPD no.403 Loni Maharashtra

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  8828143929  
Fax    
Email  prachithorat0077@gmail.com  
 
Source of Monetary or Material Support  
Dr Apj Abdul Kalam College Of Physiotherapy, Loni ,Taluka- Rahata, District Ahmednagar Pin-413736  
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Private medical college 
 
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 Prachi Thorat  Dr Apj Abdul Kalam College Of Physiotherapy  Opd no 403 Department Of Orthopaedic Physiotherapy fourth floor Dr Apj Abdul Kalam College Of Physiotherapy
Ahmadnagar
MAHARASHTRA 
8828143929

prachithorat0077@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE  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 
Comparator Agent  Conventional Protocol  1.Hot water fermentation Frequency - 2 times per day for 3 days per week. Duration - 10 min 2.Transcutaneous Electrical Nerve Stimulation Frequency - 3 days per week 10hz and 5 mA Intensity - As per tolerance Time - 7 min Type - Acupuncture Tens 3.Strecthing for upper limb, lower limb Frequency - 3 times per week duration - 30 sec hold 4 set 15 sec relaxation period 4.Aerobic exercise (walking, cycling ). Frequency - 3 days per week Duration - 30 min 5.Strengthening exercise Frequency - 3 times per week 8 to 10 reps 2- 3 reps Intensity - moderate Duration - 10 min per session Type - Resistance Band. The protocol will be 3 days per week for 4 weeks for 40 to 50 min.  
Intervention  Structured Protocol  Exercise protocol will be of 40 Minutes. Subjects will be undergoing the exercise session for 40 min for 3days per week for the period of 4 weeks. The exercise regimen will be consisted of 5mins warm up session which included brisk walking , curl ups, neck rotations and gentle stretching. 30 min intervention phase Upper limb and lower limb patterns was administered in standing, resistance was given through weight cuff (weights cuff were selected ranging from least resistance i.e 0.5 kg to 2kg.) based on 10 RM According To FITT Principle - F - 3days /week (alternate days alternate muscle group ) I- moderate intensity 40% to 60% of 10 RM T- 30 min T- weight cuff Upper Limb Muscles - 1. Trapezius 2.Biceps 3.Triceps 4.Pectoralis major Lower Limb Muscles - 1. Quadriceps 2. Hamstrings 3. Calf 4. Glutei Cool Down Phase: Strechings for the same muscles will be given.  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients willing to participate
2.Patients diagnosed with type 2 DM with HbA1c ≥ 6.4
3.BMI ≥ 23 kg/m2
4.Patient able to perform 10RM using weight cuff
5.Patients hand grade 3 in MMT 
 
ExclusionCriteria 
Details  Cardiac disorders such as coronary artery disease atrial fibrillation
Respiratory disorders
Patient not willing to participate
Orthopaedic Abnormalities 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Glycosylated Haemoglobin(HbA1c)  Data will be recorded baseline and fourth week 
 
Secondary Outcome  
Outcome  TimePoints 
Repitition maximum  Data will be recorded baseline & fourth week 
 
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)   15/03/2024 
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="6"
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   AIMS AND OBJECTIVES 
To study the effect of resistance exercises on blood glucose level (HbA1C) in patients with type 2 Diabetes Mellitus coming to rural health setup
To find out the effect of resistant exercises on blood glucose level
HbA1C 
10RM

SELECTION CRITERIA 
INCLUSION CRITERIA 
1 Patients willing to participate 
2 Patients diagnosed with type 2 DM with HbA1C≥ 6.4
3 BMI ≥ 23 kg/m2
4 Patient able to perform 10RM using weight cuff
5 Patients hand grade 3 in MMT

EXCLUSION CRITERIA 
   1 Elevated BP (resting BP> 200/115)
   2 Cardiac disorders such as coronary artery disease, atrial fibrillation.
   3 Respiratory disorders .
   4 Patient not willing to participate
   5 Orthopaedic Abnormalities

EXERCISE PROTOCOL
 Exercise Protocol will be of 40 Minutes. 
Subjects will be undergoing the exercise session for 40 min for 3days per week for the period of 4 weeks.
The exercise regimen will be consisted of  5mins  warm up session which included  brisk walking , curl ups, neck rotations and gentle stretching. 
30 min intervention phase 
Upper limb and lower limb patterns was administered in standing, resistance was given through weight cuff (weights cuff were selected ranging from least resistance i.e 0.5 kg to 2kg.) based on 10 RM
According To FITT Principle -
F -  3days /week (alternate days alternate muscle group )
I-   moderate intensity 40% to 60% of 10 RM
T-  30 min 
T-  weight cuff 
Upper Limb Muscles -        
1. TRAPEZIUS
2.BICEPS 
3.TRICEPS 
4.PECTORALS  MAJOR
       Lower Limb Muscles -
1. QUADRICEPS 
2.HAMSTRINGS
3.CALF 
4. GLUTEI  
   
COOL DOWN PHASE 
STRECHINGS FOR THE SAME MUSCLES WILL BE GIVEN 

STATISTICAL ANALYSIS
The Data collected will be analyzed by various statistical methods mean, median and test of significance, The data will be analyzed with IBM SPSS 25 for windows statistical software. For all statistical analyses, probability levels of P < 0.05 will be considered statistically significant

STUDY PERIOD  6 Months

 AMENDMENT OF PROTOCOL
No change in the study procedure shall be affected without the mutual agreement of investigator, physician and ethical committee

 CONFIDENTIALITY 
     The identity of patient generated in the study will be bounded in strict confidence. The remaining data will be available only to the investigator involved in the study and to the regulatory authorities. Break in the confidentiality is possible only after detail review by the investigator and with the permission of the ethical committee. Information will be disclosed to the concerned person/authority under special circumstances like severe unreported untoward reactions.



 
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