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CTRI Number  CTRI/2025/03/082428 [Registered on: 17/03/2025] Trial Registered Prospectively
Last Modified On: 19/03/2025
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   How calf muscle exercises and full body exercises helps to improve walking, stamina and blood sugar in prediabetics 
Scientific Title of Study   Effect of Soleus muscle exercise and aerobics exercises on gait speed, endurance and glycated hemoglobin test in pre-diabetics 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rudri Vora 
Designation  MPT Student 
Affiliation  Sunandan Divatia School of Science 
Address  Department of Physiotherapy, Ground Floor, Nanavati Max Super Speciality Hospital, Swami Vivekananda Rd, next to Suresh Colony, LIC Colony, Suresh Colony, Vile Parle West, Mumbai, Maharashtra 400056
Sunandan Divatia School of Science, Bhaktivedanta Road, Vile Parle West Mumbai MAHARASHTRA 400056 India
Mumbai (Suburban)
MAHARASHTRA
400056
India 
Phone  9969320567  
Fax    
Email  rudrivora25@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shailja Mehta 
Designation  Assistant Professor 
Affiliation  Sunandan Divatia School of Science 
Address  Sunandan Divatia School of Science, Department of Physiotherapy 7th floor Mithibai College Building, Bhaktivedanta Road, Vile Parle West Mumbai MAHARASHTRA 400056 India

Mumbai (Suburban)
MAHARASHTRA
400056
India 
Phone  9825382610  
Fax    
Email  shailja.mehta@nmims.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Shailja Mehta 
Designation  Assistant Professor 
Affiliation  Sunandan Divatia School of Science 
Address  Sunandan Divatia School of Science, Department of Physiotherapy 7th floor Mithibai College Building, Bhaktivedanta Road, Vile Parle West Mumbai MAHARASHTRA 400056 India

Mumbai (Suburban)
MAHARASHTRA
400056
India 
Phone  9825382610  
Fax    
Email  shailja.mehta@nmims.edu  
 
Source of Monetary or Material Support  
Nanavati Max Super Specialty Hospital, Swami Vivekananda Road, Next to Suresh colony Mumbai, LIC Colony, Vile parle (west), Mumbai (400056), India 
 
Primary Sponsor  
Name  NONE 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 Shailija Mehta  Nanavati Max Super Specialty Hospital  Department of Physiotherapy, Ground Floor, Nanavati Max Super Specialty Hospital, Swami Vivekananda Rd, next to Suresh Colony, LIC Colony, Suresh Colony, Vile Parle West, Mumbai, Maharashtra 400056
Mumbai (Suburban)
MAHARASHTRA 
02261347560

shailja.mehta@nmims.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Nanavati Max Super Specialty Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  Aerobic exercises + soleus exercises   A total 39 participants were divided into groups. Group 1 with soleus muscle exercises. the duration is for 6 weeks 3 days per week  
Comparator Agent  only aerobic exercises   Group 3 with soleus muscle and aerobic exercise the duration is for 6 weeks 3 days per week  
Comparator Agent  only soleus exercises   Group 2 with aerobic exercises the duration is for 6 weeks 3 days per week  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with prediabetes HBA1C between 5.7percent 6.4 percent
Age group 40 to 60
 
 
ExclusionCriteria 
Details  Diabetes mellitus (type 1)
Recent history of cardiopulmonary surgery
Patient with history of vertigo and stroke and any neurological disease
Patient with recent history of musculoskeletal injury or surgery that would hamper participation in the study
 
 
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   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1 Six Minute Walk Test
2 Gait speed test  
Pre and Post 6 weeks interventions 
 
Secondary Outcome  
Outcome  TimePoints 
Glycated Hemoglobin Test will be taken pre & post  6 weeks intervention 
 
Target Sample Size   Total Sample Size="39"
Sample Size from India="39" 
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)   24/03/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

TITLE: Effect of Soleus muscle exercises and aerobic exercises in gait speed, endurance and glycated hemoglobin on pre-diabetics

INTRODUCTION: Pre-diabetes is a significant public health concern, characterized by elevated blood glucose levels that do not yet meet the criteria for diabetes. Lifestyle modification based on exercise intervention is still the primary way to delay or reverse the development of diabetes in patients with prediabetes. However, there are still challenges in setting up a detailed exercise prescription for people with prediabetes. 

RATIONALE: Prediabetes is a high-risk state for diabetes. Therefore, prediabetes is subject to early intervention to mitigate some of the potential consequences of developing diabetes. Various studies have demonstrated that lifestyle modification and pharmacological interventions play a significant role in delaying the progression of prediabetes to diabetes. Moreover, the choice of pharmacological interventions appears to put patients at higher risk. Therefore, lifestyle is currently the intervention of choice for prediabetes. As an essential component of lifestyle interventions, exercise interventions have been shown to aid the benign regression of prediabetes. Moreover, evidence has shown improvement in prediabetes with aerobic and resistance exercises, but the study has not been done for the individual muscle training as soleus muscles exercises.

AIM: To assess the impact of soleus muscle exercises and aerobic exercises on gait speed, endurance, and glycated hemoglobin (HbA1c) in pre-diabetic individuals.

OBJECTIVES: To assess the effect of soleus muscle exercises on gait speed, endurance and glycated hemoglobin. To assess effect of aerobic exercises on gait speed, endurance and glycated hemoglobin. To assess the effect of soleus muscle exercises and aerobic exercises on gait speed, endurance and glycated hemoglobin. To compare effect of three groups

OUTCOME MEASURES: 1. Gait speed test - To assess walking speed in m/s. 2. 6-minute walk test - to assess endurance. 3. Glycated hemoglobin – To assess blood sugar level

PROTOCOL: The intervention is developed for group 1 will be given soleus muscles exercise for 6 weeks. Group 2 will be given aerobic exercises (heel digs, step touch, 1,2,3 tap, marching, walking kick, slide, grape vine, V box steps, jazz walk, shuffle back, lunges, step up and down, jumping jack) for 6 weeks and group 3 will be given aerobic and soleus muscle exercises for 6 weeks. Gait speed and endurance were assessed using a gait speed test and a six-minute walk test, respectively and glycated hemoglobin levels were measured. Above mentioned test will be performed before and after the intervention period. 

Key Words: Prediabetes, Solus muscle exercises and aerobic exercises,

 
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