FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2018/05/013708 [Registered on: 07/05/2018] Trial Registered Prospectively
Last Modified On: 23/11/2019
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Association of Obesity and knee strength in older adults with pain in the knee joint 
Scientific Title of Study   Association of BMI and Quadriceps Muscle Strength with Physical Function in Community-dwelling Older adults with Knee Osteoarthritis: A Cross-Sectional Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sonali Krushna Vispute 
Designation  Postgraduation Student 
Affiliation  DVVPFs College of Physiotherapy 
Address  DVVPFs College of Physiotherapy, Opposite to Government Milk Dairy, MIDC, Ahmednagar.
DVVPFs College of Physiotherapy, Opposite to Government Milk Dairy, MIDC, Ahmednagar.
Ahmadnagar
MAHARASHTRA
431003
India 
Phone  8208056102  
Fax    
Email  sonalivispute17@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shyam D Ganvir 
Designation  PRINCIPAL, PROFESSOR, H.O.D. Dept. of Community Medical Sciences 
Affiliation  DVVPFs College of Physiotherapy 
Address  Dr. vitthalrao vikhe patil college of physiotherapy. opp. govt milk dairy, M.I.D.C., AHMEDNAGAR opp. govt milk dairy, M.I.D.C., AHMEDNAGAR.
DVVPFs College of Physiotherapy, Opposite to Government Milk Dairy, MIDC, Ahmednagar.
Ahmadnagar
MAHARASHTRA
414111
India 
Phone  8554990224  
Fax    
Email  shyam.ganvir@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sonali Krushna Vispute 
Designation  Postgraduation Student 
Affiliation  DVVPFs College of Physiotherapy 
Address  Plot No. F-11/A, Sambhaji Colony, N-6 , CIDCO, Aurangabad.
DVVPFs College of Physiotherapy, Opposite to Government Milk Dairy, MIDC, Ahmednagar.
Ahmadnagar
MAHARASHTRA
431003
India 
Phone  8208056102  
Fax    
Email  sonalivispute17@gmail.com  
 
Source of Monetary or Material Support  
Dr. Vithalrao Vikhe Patil Foundations College of Physiotherapy, Opp Govt. Milk Dairy, MIDC, Ahmednagar-414111 
 
Primary Sponsor  
Name  DVVPFS College of Physiotherapy 
Address  opp. govt milk dairy, M.I.D.C., AHMEDNAGAR. 
Type of Sponsor  Private medical college 
 
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 
Sonali Vispute  DVVPFs COLLEGE OF PHYSIOTHERAPY  opp. govt milk dairy, M.I.D.C., AHMEDNAGAR Ahmadnagar MAHARASHTRA
Ahmadnagar
MAHARASHTRA 
8208056102

sonalivispute17@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Knee Osteoarthritis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1) Community- dwelling older adults.
2) Diagnosed osteoarthritis of knee joint (Kellgren-Lawrence Grade 1 and 2). 
 
ExclusionCriteria 
Details  1) History of recent B/L or U/L knee replacement.
2) History of Rheumatologic disease.
3) Had any medical conditions that would compromise physical function.
4) Required another person or an assistive device to walk. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Body Mass Index  single time 
 
Secondary Outcome  
Outcome  TimePoints 
Quadriceps Muscle Strength  single time 
30-second Chair Stand Test  single time 
Older people’s Quality of Life Questionnaire  single time 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   07/05/2018 
Date of Study Completion (India) 05/11/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  
Aims and Objectives:
1. To determine whether there is association of BMI with Physical function in community-dwelling older adults with knee osteoarthritis.
2. To determine whether there is association of quadriceps muscle strength with Physical function in community-dwelling older adults with knee osteoarthritis.
3.To find out quality of life in community-dwelling older adults with knee osteoarthritis.
Method:
Subjects with osteoarthritis of knee joint will be enrolled in this study. Written informed consent will be obtained from all participants after explanation of the details of this study and its benefits and risk in their own language. The study protocol will be approved by the ethical committee of College of Physiotherapy. Subjects will be selected based on inclusion and exclusion criteria by purposive sampling technique. The Body Mass Index will be derived from data collection sheet and quadriceps muscle strength will be assessed by Modified sphygmomanometer instrument. The 30-second Chair Stand Test will be used to assess the Physical Function in older adults with osteoarthritis knee. The older people’s quality of life questionnaire is a tool to assess the quality of life in the following domains: life overall, health, social relationships, independence, home and neighbourhood, psychological and emotional well-being, financial circumstances, leisure and activities.
PROCEDURE:
BODY MASS INDEX:
Calculated by = Weight (kg)/ Height (cm2)
QUADRICEPS MUSCLE STRENGTH:
It is measured by Modified Sphygmomanometer instrument.
Procedure:
In the high sitting position, hip and knee flexed to 90°, resistance will be applied just proximal to the ankle on the anterior surface of leg. For the quadriceps muscle, manual stabilization will be provided at distal and anterior on the thigh. Before the assessments, the subjects will be asked to perform a submaximal isometric contraction with modified sphygmomanometer, which will be pre-inflated to 20 mmHg, will be then placed in a position to resist the movements generated by the muscle group. During trial efforts, the subjects will be verbally encouraged to exert their maximal isometric contractions over 5 sec. The examiners will apply manual resistance against the movement, maintaining the body segment static. After familiarization, 3 trials of maximal isometric contractions will be performed by the patient, with the sphygmomanometer. The peak values will be recorded. Rest intervals of 15 s between trials will be allowed.
30-SECOND CHAIR STAND TEST:
Abbreviation: 30s-CST
Description
The maximum number of chair stand repetitions possible in a 30 second period.
Equipment
Timer/stop watch.
Straight back chair with a 44cm (17 inch) seat height, preferably without arms.
Preparation
Environment
Ensure the chair cannot slide backwards by placing the back of the chair against a wall.
Participant
Comfortable walking footwear should be worn.
The participant sits in the chair in a position that allows them to place their feet flat on the floor, shoulder width apart, with knees flexed slightly more than 90 degrees so that their heels are somewhat closer to the chair than the back of their knees.
The arms are crossed at the wrists and held close to the chest (across chest).
Tester
The tester stands close to the side of the chair for safety and so as they can observe the technique, ensure that the participant comes to a full stand and full sit position during the test.
Procedure
From the sitting position, the participant stands up completely up so hips and knees are fully extended, then completely back down, so that the bottom fully touches the seat. This is repeated for 30 seconds.
Same chair should be used for re-testing within site.
If the person cannot stand even once then allow the hands to be placed on their legs or use their regular mobility aid. This is
then scored as an adapted test score.
Verbal instructions
“For this test, do the best you can by going as fast as you can but don’t push yourself to a point of overexertion or beyond
what you think is safe for you.
Place your hands on the opposite shoulder so that your arms are crossed at the wrists and held close across your chest. Keep your arms in this position for the test.
Keep your feet flat on the floor and at shoulder width apart.
On the signal to begin, stand up to a full stand position and then sit back down again so as your bottom fully touches the seat.
Keep going for 30 seconds and until I say stop.
Get ready and START”.
Scoring
On the signal to begin, start the stop watch. Count the total number of chair stands (up and down equals one stand) completed in 30 seconds. If a full stand has been completed at 30 seconds (i.e. standing fully erect or on the way down to the sitting position), then this final stand is counted in the total.
The participant can stop and rest if they become tired. The time keeps going.
If a person cannot stand even once then the score for the test is zero.
Next, allow the hands to be placed on their legs or use their regular mobility aid. If the person can stand with adaptions, then record the number of stands as an adapted test score.

 
Close