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CTRI Number  CTRI/2025/01/079014 [Registered on: 20/01/2025] Trial Registered Prospectively
Last Modified On: 21/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Effect of upright sitting on abdominal strength as compared to core exercises in University students  
Scientific Title of Study   Effect of sensor monitored upright sitting as intervention on core muscle thickness and contractibility spinal posture in asymptomatic university students A Randomized controlled trial  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Varsha Huddar 
Designation  Assistant Professor 
Affiliation  KLE Institute of Physiotherapy 
Address  Dept of Biomechanics Physiotherapy KLE Institute of Physiotherapy Nehru Nagar Belagavi Dept of Biomechanics Physiotherapy KLE Institute of Physiotherapy Nehru Nagar Belagavi Belgaum
KLE INSTITUTE OF PHYSIOTHERAPY
Belgaum
KARNATAKA
590010
India 
Phone  9880733370  
Fax    
Email  drvarshabadli@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Varsha Huddar 
Designation  Assistant Professor 
Affiliation  KLE Institute of Physiotherapy 
Address  Dept of Biomechanics Physiotherapy KLE Institute of Physiotherapy Nehru Nagar Belagavi Dept of Biomechanics Physiotherapy KLE Institute of Physiotherapy Nehru Nagar Belagavi Belgaum
KLE INSTITUTE OF PHYSIOTHERAPY
Belgaum
KARNATAKA
590010
India 
Phone  9880733370  
Fax    
Email  drvarshabadli@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sanjiv Kumar 
Designation  Professor Principal 
Affiliation  KLE Institute of Physiotherapy 
Address  KLE Institute of Physiotherapy Nehru Nagar Belagavi KLE Institute of Physiotherapy Nehru Nagar Belgaum
KLE INSTITUTE OF PHYSIOTHERAPY
Belgaum
KARNATAKA
590010
India 
Phone  9448745648  
Fax    
Email  sanjiv3303@rediffmail.com  
 
Source of Monetary or Material Support  
KLE Institute Physiotherapy Belagavi-590010 Karnataka 
 
Primary Sponsor  
Name  Varsha Huddar 
Address  KLE Institute of Physiotherapy Belagavi-590010 Karnataka 
Type of Sponsor  Other [[Individual Primary researcher]] 
 
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 Varsha Huddar  KLE Institute of Physiotherapy  Fitness room, 2nd floor room no 24 Nehru Nagar Belagavi Belgaum KARNATAKA
Belgaum
KARNATAKA 
9880733370

drvarshabadli@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KAHER Ethics Committee on Human Subjects  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy individuals with core weakness  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  conventional exercises   following exercises will be given one leg sliding Supine lying Leg lifts Crook lying with Crunches Knee to Chest Static back Pelvic bridging Lumbar spine rotation Prone lying Leg lifts Cat and Camel exercises Prone lying Trunk lifts All these exercises will be give for 1 time 10 repetition  
Intervention  upright sitting combined with conventional exercises   upright sitting as a intervention will be given which will be monitored by sensors attached at lumbar spine for 1 hour every alternate days for 4 weeks along with this conventional exercises will be given every alternate day for 4 weeks  
Intervention  upright sitting monitored by sensor  upright sitting will be used as a intervention which will be monitored with the help of sensor attached at lumbar spine level for the duration of 1 hour every alternate days for 4 weeks  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  Asymptomatic individuals of all genders
Age 18 to 25 years
Plank hold test- less than or equal to below average 
 
ExclusionCriteria 
Details  Diagnosed musculoskeletal and systemic disorders which have a impact on posture and pulmonary functions
Currently on any exercise training programs
Physical disabilities
Any other medical or surgical condition that prevents person from participating in exercise program 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
core muscle strength by plank hold test
core muscle contractibility as assessed by surface EMG
core muscle thickness as assessed by ultrasonography  
3 time points (0 4 and 8)
Baseline data at 0 week
Post intervention at 4th weeks
Follow up 8th week  
 
Secondary Outcome  
Outcome  TimePoints 
posture as assessed by APECS application
Respiratory function as assessed by portable spirometer  
pre (0week) and post (4th week) intervention 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   01/02/2025 
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="3"
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  

Students spend majority of their time sitting in classrooms, especially healthcare students due to prolonged sitting hours for extended teaching classes and for study purpose are prone for bad posture, muscle imbalance and low back pain. Increasing literature supports extended period of bad posture, such as slouching, are linked to the development of non-specific lower back pain (LBP). Prevalence of back (including lower back and thoracic) pain was 76% across India and people spent nearly 62,880 INR on medical consultation. Low back pain often is a result of muscle imbalance of back and core muscle.. There are many prevalence studies towards low back pain in healthcare students, but dearth in prevention studies to address the posture and muscle imbalance. 

As per literature many exercise therapies like core stability exercise, resistance training have been tried for core muscle strengthening and they have shown good improvement, but there are many barriers attached with home based exercise programs given for a patients with back pain. It is also noted that home based exercises are effective only when are monitored by an expert. Research recognized many treatment for low back pain, once it has started however it would seem logical to prevent the conditionThere are many lumbar support chairs available in market to help maintain the correct posture encouraging more neutral low back posture while sitting but reduces muscle activity.

The tonic activation of the core muscles that maintain the spine increases when seated upright in a chair, as well has positive effect on pulmonary function and overall wellbeing of the person. Though there are many articles supporting the upright sitting posture for abdominal muscle activation but there is dearth of literature of upright sitting as a intervention monitored by sensors on abdominal muscle strength. Sensors can give a valid data for the duration of a person sitting upright which can help to quantify the effect of upright sitting on core muscles 

This intervention if proven significant for improving muscle strength would be one of the cost-effective method, which can be administered and practiced by all age groups. Hence the current study is undertaken to check the effectiveness of sensor monitored upright sitting on abdominal muscle strength alone and in combination with conventional exercises on core muscle strength.

 
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