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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Knee Osteoarthritis, |
|
Intervention / Comparator Agent
|
|
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 STARTâ€. 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.
|