| CTRI Number |
CTRI/2023/10/058828 [Registered on: 18/10/2023] Trial Registered Prospectively |
| Last Modified On: |
12/10/2023 |
| 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
|
Effects of Abdominal Strengthening exercises in fitness in diabetes patient |
|
Scientific Title of Study
|
Effects of core strengthening exercises on cardio respiratory fitness in type 2 diabetes |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shaheen Arkate |
| Designation |
MPT Student |
| Affiliation |
|
| Address |
Department of Physiotherapy, Ground Floor, Nanavati Max Super Speciality Hospital SV Road, Vile Parle-West, Bhaktivedanta Road, Mumbai(Suburban)
Sunandan Divatia School of Science SVKMs Bhaktivedanta Swami Road Vile Parle West Mumbai Maharashtra 400056
Mumbai (Suburban)
MAHARASHTRA
400056
India |
| Phone |
9967024702 |
| Fax |
|
| Email |
arkateshaheen40@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Poonam Parulekar |
| Designation |
Assistant Professor |
| Affiliation |
Sunandan Divatia School of Science |
| Address |
Department of Physiotherapy Sunandan Divatia School of Science 7th floor Mithibai College building SVKMs Bhaktivedanta Swami Road Vile Parle West Mumbai Maharashtra 400056
Mumbai (Suburban)
MAHARASHTRA
400056
India |
| Phone |
9821820233 |
| Fax |
|
| Email |
poonam.parulekar@nmims.edu |
|
Details of Contact Person
Public Query
|
| Name |
Shaheen Arkate |
| Designation |
MPT Student |
| Affiliation |
|
| Address |
Department of Physiotherapy, Ground Floor, Nanavati Max Super Speciality Hospital SV Road, Vile Parle-West, Bhaktivedanta Road, Mumbai(Suburban)
Sunandan Divatia School of Science SVKMs Bhaktivedanta Swami Road Vile Parle West Mumbai Maharashtra 400056
Mumbai (Suburban)
MAHARASHTRA
400056
India |
| Phone |
9967024702 |
| Fax |
|
| Email |
arkateshaheen40@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nanavati Max Super Specialty Hospital LIC Colony Suresh Colony Vile Parle West Mumbai Maharashtra 400056 |
|
|
Primary Sponsor
|
| Name |
Shaheen Arkate |
| Address |
Department of Physiotherapy, Ground Floor, Nanavati Max Super Speciality Hospital SV Road, Vile Parle-West, Bhaktivedanta Road, Mumbai(Suburban), Maharashtra, 400056
|
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Shaheen Arkate |
Nanavati Max Super Speciality Hospital |
Department of Physiotherapy, Ground Floor, Nanavati Max
Superspeciality Hospital, SV road, Vile Parle
west, Mumbai 400056
MAHARASHTRA
Mumbai (Suburban)
MAHARASHTRA |
9967024702
arkateshaheen40@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. Balabhai Nanavati Hospital (Charitable) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
core strengthening exercises in type 2 diabetes mellitus |
pre and post assessment of outcome measures will be taken after 4 weeks. |
| Intervention |
core strengthening exercises in type 2 diabetes mellitus |
pre assessment will be taken patient has to perform core strengthening exercises for 4 weeks 3 times per week after 12 sessions post assessment that the outcome measures will be reassessed
total duration- one month i.e four weeks |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Individuals diagnosed with type 2 diabetes mellitus and are on regular medications. |
|
| ExclusionCriteria |
| Details |
individuals having any cardiovascular or musculoskeletal problems
BMI of more than 40kg/m2
any chronic respiratory condition |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
VO2max
Vital Capacity
Endurance
Core Strength |
pre and post assessment of the outcome measures will taken after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
waist hip ratio
abdominal girth |
pre and post assessment of the outcome measures will taken after 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
24/10/2023 |
| 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 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
|
Type 2 Diabetes Mellitus is one of the most common non-communicable disease in India. Type 2 Diabetes affects the way the body regulates and uses glucose. the pancreas in unable to produce sufficient insulin, which results in impaired uptake of sugar by the body. Now-a-days Diabetes is predominantly seen in younger populations having sedentary lifestyle, genetic exposure, increased carbohydrate and fat intake, reduced physical activity etc. Diabetes affect various systems of the body respiratory system being one of them. Due to Diabetes the endothelial lining of the pulmonary vessels get affected, which leads reduced vital capacity and FEV1, giving a restrictive pattern in long term. A good core muscle will help in good pulmonary functions as diaphragm and transversus abdominis muscle go hand in hand. Aim of the study: To assess the effects of core strengthening exercises on cardio respiratory fitness of patients with type 2 diabetes. Objectives: To assess effect of core strengthening exercise on the following parameters:1.Core Strength 2.VO2 Max 3.Vital Capacity 4.Abdominal Girth 5.Waist Hip Ratio. Procedure: young participants age group(35 to 60 years) having type 2 diabetes for more than one year and are on regular medications will be recruited for the study. the study will explained and consent will be taken from the participants. outcome measures will assessed at the start of the protocol. 12 sessions would be administered. week1 exercises- core activation, bridging, heel to hand, cat and camel, high knees prone- alternate arm and leg raise. week2 exercises- alongwith week 1 exercises, eccentric crunches on stool, air cycling, incline plank, jack twists, squat and side chops, side plank and prone plank and flutter kicks will be added. week3 exercises- alongwith week 1 and week 2 exercises russian twists, lower limb raises at multiple angles will be added. week4 exercises- alongwith week 1, week 2 and week 3 exercises crunches and obliques, side plank with pelvic movement and hundreds will be added. After completion of this protocol for 4 weeks i.e 3 sessions per week, post assessment of all the outcome measures will be taken. w |