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CTRI Number  CTRI/2023/10/059073 [Registered on: 25/10/2023] Trial Registered Prospectively
Last Modified On: 23/10/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Importance of lumbar core stabilization exercises on pulmonary functions, pain, dynamic balance and functional activities in patients with knee Osteoarthritis 
Scientific Title of Study   Effects of lumbar core endurance training and stabilization exercises on pulmonary functions, pain, dynamic balance and functional activities in patients with knee OA 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  MAULIK SHAH 
Designation  Consultant Physiotherapist 
Affiliation  Civil Hospital 
Address  Physiotherapy Department, Civil Hospital, Bhagavatpara, Gondal.
Bhagavatpara,Gondal
Rajkot
GUJARAT
360005
India 
Phone  9426818495  
Fax    
Email  maulikshah50@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  MAULIK SHAH 
Designation  Consultant Physiotherapist 
Affiliation  Civil Hospital 
Address  Physiotherapy Department, Civil Hospital, Gondal
Bhagavatpara,Gondal
Rajkot
GUJARAT
360311
India 
Phone  9426818495  
Fax    
Email  maulikshah50@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  MAULIK SHAH 
Designation  Consultant Physiotherapist 
Affiliation  Civil Hospital 
Address  Superintendent office, Civil Hospital, Gondal.
Bhagavatpara,Gondal
Rajkot
GUJARAT
360311
India 
Phone  9426818495  
Fax    
Email  maulikshah50@yahoo.com  
 
Source of Monetary or Material Support  
Government Hospital, Bhagvatpara, Gondal , Dist - Rajkot, Gujarat 
 
Primary Sponsor  
Name  Government Hospital 
Address  Government Hospital, Bhagvatpara, Gondal , Dist - Rajkot, Gujarat 
Type of Sponsor  Other [Gujarat Government Hospital] 
 
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 Maulik Shah  Civil Hospital,Gondal  Physiotherapy Department,Civil Hospital,BhagavatPara,Gondal
Rajkot
GUJARAT 
9426818495

maulikshah50@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Local NOC from Civil Hospital Gondal  Approved 
Shree Giriraj Hospital Research Ethics Commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  TENS, Infrared rays, Ultrasound, Q - Drills Exercises  1) Ultrasound- 1MHz, 1.2 Watts/cm2 for 5 minutes 2) IR – 10 minutes with comfortable heating 3) TENS for 10 minutes, using modulated mode with comfortable intensity 4) Q- drill exercises(Knee muscles strengthening protocol) Static quadriceps exercise, Terminal knee extension, Straight leg raise, Hip abductors strengthening, High sitting quadriceps strengthening. Frequency: 2 sets of 10 repetitions.  
Comparator Agent  TENS, Infrared Rays, Ultrasound, Q - Drills Exercises, Lumbar Core Stability Exercises   1) Ultrasound- 1MHz, 1.2 Watts/cm2 for 5 minutes 2) IR – 10 minutes with comfortable heating 3) TENS for 10 minutes, using modulated mode with comfortable intensity 4) Q- drill exercises(Knee muscles strengthening protocol) Static quadriceps exercise, Terminal knee extension, Straight leg raise, Hip abductors strengthening, High sitting quadriceps strengthening, Frequency: 2 sets of 10 repetitions. lumbar core endurance training: 1. Supine Abdominal Draw In 2. Abdominal Draw In with Heel Slide 3. Abdominal Draw In with Double Knee to Chest 4. Supine Twist 5. Dead Bug exercise 6. Supine Butt Lift with Arms at Side 7. Abdominal Draw In with feet on the ball Patients would receive treatment 6 days a week for 6 weeks of duration.  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patient referred to physiotherapy department by orthopedician or any medical practioner for Knee OA with kellgren Lawrence classification grade II & grade III from x ray defined by an orthopedician.
2. Patients’ chief complaint is related to pain around the knee joint with difficulties in ADLs like sit to stand, stair climbing etc...
3. Age of patient- 40 years & above
4. Genders : Male & females both are included
5. Patients who are able to comprehend commands
 
 
ExclusionCriteria 
Details  1.Trauma and neurological condition of lumbosacral spine.
2.Previous surgery over lumbar spine/ hip / knee / ankle
3.Systemic illness like lower extremity vascular disorder
4.Patients with known case of pulmonary disorders
5.History of lower limb fracture
6.Medical red flags
7.Non-cooperative patient
The above stated conditions will be ruled out on the discretion of a Medical Professional.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Score with Numeric Pain Rating Scale, Score With Modified WOMAC Scale, Score with Community Balance & Mobility Scale, Litre with FEV1, Litre with FVC, % with FEV1/FVC  NPRS, Modified WOMAC scale score, Value of FEV1 & FVC will be measured at the first day of treatment & 6 weeks of treatment. 
 
Secondary Outcome  
Outcome  TimePoints 
Sociodemographic Charecteristics Questionnaire, Visual analogue scale to evaluate Fatigue Severity, Visual Analogue Scale, Beck depresson inventory.   Follow up would be taken at 6 months regular intervals for 3 years. 
 
Target Sample Size   Total Sample Size="310"
Sample Size from India="310" 
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 3 
Date of First Enrollment (India)   06/11/2023 
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="9"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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  

Osteoarthritis (OA) is a degenerative joint disease & the knee is the most common site for OA with the prevalence varying from 26% to 63% depending on age and gender. Knee OA is a multifactorial disorder resulting from several contributing factors including trauma, anatomical factors, biomechanical muscle imbalance, and occupational hazards.

                        Few studies have focused on the contribution of core stability to dynamic knee joint stability, mobility & function. The core of the body provides a foundation upon which the muscles of the lower extremities produce or resist force. The core is constructively a muscular box in which diaphragm is on the top, the pelvic floor and hip girdle musculature as the bottom, abdominals in the anterior, and the paraspinal and gluteal muscles behind. All the hip musculatures have their origins in pelvic and lumbar regions s o that the compromised core can be responsible for an unstable proximal base and quality muscle recruitments for stability as well as mobility.          

               There is always a vicious cycle related to weakness of core stabilizers/ spinal stabilizers and lower extremity muscles. Initially there would be weakness of lower limb muscles that overburdened core muscles due to length – tension relationship between them.Decreased core stability and muscular synergism of the trunk and hip stabilizers may affect performance in ADLs as well affect balance & mobility.

              The weakening of core muscles in knee OA patients also affects their primary and secondary respiratory muscles. Strong Abdominal muscle contraction is needed to increase intra-abdominal pressure, dis­charges the air to the outside of the diaphragm, and is necessary for bucking for airway clearance. Weak abdominals used to affect FEV1 & FVC value, thus affecting respiratory functions.

 

NEED OF THE STUDY

In spite of many researches done on proximal stability training i.e. core and hip strengthening

for prevention of lower extremity injuries and also studies done on deficits of neuromuscular control of the trunk to predict risks of knee injuries, there are no studies correlating the core and lower limb muscles strength, functional activity level as well as correlation between core strength and pulmonary functions influencing the most common musculoskeletal condition i.e. knee osteoarthritis. Therefore, the purpose of our study is to find out Effects of lumbar core endurance training and stabilization exercises on pulmonary function, pain, dynamic balance and functional activities in patients with knee OA.

AIM & OBJECTIVES

The aim of the present work is to study the Effects of lumbar core endurance training and stabilization exercises on pulmonary function, pain, dynamic balance and functional activities in patients with knee OA.

OBJECTIVES

·         To study the additive effect of lumbar core endurance training and stabilization exercises on pulmonary function, pain, dynamic balance and functional activities in patients with knee OA.

 

·         To study the effect of conventional physiotherapy treatment on pulmonary function, pain, dynamic balance and functional activities in patients with knee OA.

 

·         To compare the effect of lumbar core endurance training and stabilization exercises and conventional physiotherapy on pulmonary function, pain, dynamic balance and functional activities in patients with knee OA.

 
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