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CTRI Number  CTRI/2024/01/061944 [Registered on: 29/01/2024] Trial Registered Prospectively
Last Modified On: 25/01/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   To see the effect of ankle push up exercise on blood sugar level in diabetic patients  
Scientific Title of Study   Immediate effect of soleus push ups on blood sugar level in patients with type 2 diabetes- A pilot study  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pradnya Mahajan  
Designation  Assistant professor  
Affiliation  Dr. Ulhas Patil college of physiotherapy  
Address  3rd Floor Physiotherapy Department Dr ulhas patil College of physiotherapy Jalgaon

Jalgaon
MAHARASHTRA
425001
India 
Phone  9284034348  
Fax    
Email  ppradz1816@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Pradnya Mahajan  
Designation  Assistant professor  
Affiliation  Dr. Ulhas Patil college of physiotherapy  
Address  3rd Floor Physiotherapy Department Dr ulhas patil College of physiotherapy Jalgaon

Jalgaon
MAHARASHTRA
425001
India 
Phone  9284034348  
Fax    
Email  ppradz1816@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mukesh shinde  
Designation  Assistant professor  
Affiliation  Dr. Ulhas Patil college of physiotherapy  
Address  3rd Floor Physiotherapy Department Dr ulhas patil College of physiotherapy Jalgaon

Jalgaon
MAHARASHTRA
4250001
India 
Phone  9021047555  
Fax    
Email  mukeshshinde31@gmail.com  
 
Source of Monetary or Material Support  
Dr. Ulhas Patil college of physiotherapy khirdi shivar Jalgaon Khurd Jalagon  
 
Primary Sponsor  
Name  Dr Pradnya Mahajan  
Address  3rd Floor Physiotherapy Department Dr ulhas patil College of physiotherapy Jalgaon  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
Dr Mukesh shinde  Soham 30C khote Nagar Jalgaon 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pradnya Mahajan   DR ULHAS PATIL MEDICAL COLLEGE & HOSPITAL, JALGAON   OPD NO. 207 Physiotherapy OPD 1st floor
Jalgaon
MAHARASHTRA 		 9284034348

ppradz1816@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee of Dr. Ulhas Patil college of physiotherapy   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  No intervention   NIL 
Intervention  Soleus push up   A soleus muscle push-up targets the soleus muscle by placing the feet flat on the ground and sitting with your knees at an angle of 90. • This position helps isolate the soleus muscle during the push-up, effectively targets the muscle, and improves glucose utilization, causing the lowering effect. • To perform a soleus muscle push-up, sit and place your feet flat, then raise your heels off the ground. • Pointing toes to the ground and ankle forward. • The tendency is to squeeze the big gastrocnemius muscle but resist this. Emphasis is on pointing toes downwards and ankles forward. With regular practice, you will begin to notice the difference. • Patients will be allowed to drink water between the treatment no cold drinks or beverages will be allow to consume during the treatment. • If the patient ask for food during the intervention then the patient will be drop out from the study. Dosage- 40 minutes of Soleus Push-ups single set. Break 30 sec or 1 minute between the exercise. Termination of exercise: After 40 minutes of Soleus-Pushups. 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Subjects with informed consent.
2 Diabetic patients between 45 60 years of age.
3 Patients with Type 2 Diabetes.
4 BSL more than 200mg per dL. 
 
ExclusionCriteria 
Details  1 Patient with Deep Veins Thrombosis (DVT).
2 Patient with arterial and venous insufficiency (Claudication).
3 Patients on blood thinner medications.
4 Previous fracture and traumatic injuries around lower limb.
• Recent surgeries around lower limb.
• Malignant condition.Soft tissueinjury.
5 Unstable Respiratory and cardiac conditions.
6 Patients on Keto-Diet.
7 Motor or sensory loss following diabetes, neurological & musculoskeletal
condition 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Blood Sugar level  Pre treatment and post treatment  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="22"
Sample Size from India="22" 
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 1 
Date of First Enrollment (India)   15/02/2024 
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="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   Approval of Institutional Ethical Committee (IEC) will be taken. Aim and procedure
of the study will be explained to all subjects before data collection.
subjects will be recruited according to the inclusion criteria & exclusion criteria of
study. A written informed consent form will be taken from all the subjects. After that
selected subjects will be divided into 2 group i.e experimental group & control group
using lottery method.
a. Glucometer reading (Blood Sugar Level) using GLUCOCARD
will be taken before the exercise intervention i.e. Pretest
sample (2 hours pre or post-meal). After taking pre meal
glucometer reading of experimental group immediately soleus
push up exercise will be given for 40 minutes & post
glucometer readings will be recorded. Glucometer reading
(Blood Sugar Level) of control group using GLUCOCARD (r=
95%) will be taken after explaining the procedure & after 40
mins without any intervention. Immediate effect of the test will
be recorded.
❖ INTERVENTION PROTOCOL:
 Patient with Type 2 Diabetes (Diabetes Mellitus) will be
recruited. And the patients will be divided into 2 groups i.e. Control group
(the group which will not receive the intervention) and the Intervention group
(the group which will receive the intervention).
GROUP A (CONTROL GROUP)
• In this group, the patients will not receive any intervention.
• Pre and Post (after 40 min) Blood Sugar level will be taken by using glucometer
GROUP B (INTERVENTION GROUP):
• A soleus muscle push-up targets the soleus muscle by placing the feet flat on
the ground and sitting with your knees at an angle of 90.
• This position helps isolate the soleus muscle during the push-up, effectively
targets the muscle, and improves glucose utilization, causing the lowering
effect.
• To perform a soleus muscle push-up, sit and place your feet flat, then raise
your heels off the ground.
• Pointing toes to the ground and ankle forward.
• The tendency is to squeeze the big gastrocnemius muscle but resist this.
Emphasis is on pointing toes downwards and ankles forward. With regular
practice, you will begin to notice the difference.
• Patients will be allowed to drink water between the treatment no cold drinks
or beverages will be allow to consume during the treatment.
• If the patient ask for food during the intervention then the patient will be drop
out from the study.
Dosage- 40 minutes of Soleus Push-ups single set.
Break- 30 sec or 1 minute between the exercise.
Termination of exercise: After 40 minutes of Soleus-Pushups.
 
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