| 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
|
|
|
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
|
|
|
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, |