| 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
|
|
|
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
|
|
|
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 condition. There 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. |