| CTRI Number |
CTRI/2024/11/076155 [Registered on: 01/11/2024] Trial Registered Prospectively |
| Last Modified On: |
01/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Functional strength training in knee osteoarthritis. |
|
Scientific Title of Study
|
Effect of functional strength training on sit to stand and functional outcome in Knee Osteoarthritis: 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 |
Dr Sachin Gupta |
| Designation |
Assistant Professor |
| Affiliation |
Galgotias University |
| Address |
Room no. B228 department of physiotherapy SAHS Galgotias University plot no. 2 yamuna expy opposite buddha international circuit sector 17A Greater Noida Uttar Pradesh India
Gautam Buddha Nagar UTTAR PRADESH 203201 India |
| Phone |
9015193829 |
| Fax |
|
| Email |
sachinguptapt3@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Tanisha Shakya |
| Designation |
Research Student |
| Affiliation |
Galgotias University |
| Address |
Room no. E005 department of physiotherapy SAHS Galgotias University plot no. 2 yamuna expy opposite buddha international circuit sector 17a Greater Noida Uttar Pradesh India
Gautam Buddha Nagar UTTAR PRADESH 203201 India |
| Phone |
8791225846 |
| Fax |
|
| Email |
shakyat030@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sachin Gupta |
| Designation |
Assistant Professor |
| Affiliation |
Galgotias University |
| Address |
Room no. B228 department of physiotherapy SAHS Galgotias University plot no. 2 yamuna expy opposite buddha international circuit sector 17A Greater Noida Uttar Pradesh India
Gautam Buddha Nagar UTTAR PRADESH 203201 India |
| Phone |
9015193829 |
| Fax |
|
| Email |
sachinguptapt3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Research and Development Cell, Galgotias University, India , 203201 |
|
|
Primary Sponsor
|
| Name |
Galgotias University |
| Address |
Room No A315 Research and Development Cell, Galgotias University, Plot No 2, Sector 17A, Yamuna Expy, opposite Buddha International circuit, Greater Noida Uttar Pradesh 203201 |
| Type of Sponsor |
Research institution |
|
|
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 Sachin Gupta |
Galgotias University |
Plot No 2, Sector 17A Opposite Gautam Buddha International Circuit, Yamuna expressway Gautam Buddha Nagar UTTAR PRADESH
Gautam Buddha Nagar
UTTAR PRADESH Gautam Buddha Nagar UTTAR PRADESH |
9015193829
sachinguptapt3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Departmental Research Committee Galgotias University Uttar Pradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Functional Strength training |
Functional strength training (FST) is gaining popularity as a new kind of exercise for people with heart conditions, middle-aged adults, athletes, and the elderly. It has been shown to improve health, help people control their weight, and improve daily activity performance. FST simulates specific movements that call for balance, strength, flexibility, and coordination.
1 week
Chair rise
Forward reach to opposite foot
Forward walking
Side step walking
Combined forward and backward walking
At preferred speed (5 rep)
2 week
Same exercises of 1st week at fast speed
Step up forward/down
Marching
Squatting
Forward and upward reach
Upper body rotation
At preferred speed (5rep)
3 week
Same exercises of 1st week at slow speed
Same exercises of 2nd week at fast speed
(5rep)
4 week
Same exercises of 1st week with adding difficulty
(such as adding weight of any object)
Same exercises of 2nd week at slow speed
(7 rep)
5 week
Same exercises of 1st week at slow speed with difficulty
Same exercises of 2nd week with more difficulty
(10rep)
6 week
Same exercises as 1st & 2nd week protocol
with changing the environment
(10 rep)
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1 Pre-diagnosed with knee OA
2 Radiographic imaging.
3 Kellgren-Lawrence scale 1,2,3.
4 Both genders are affected
|
|
| ExclusionCriteria |
| Details |
1 Any history of trauma, fracture, or surgery like total knee replacement (TKR).
2 Sever mobility-related comorbidities (e.g., neurological disorders, sever cardiovascular conditions).
3 Mortin IB, Naproxen sodium is also the first-line treatment for patients with symptomatic osteoarthritis.
4 Intra-articular hyaluronic acid injections (HA) injections and Vit B12 are another injectable option for knee osteoarthritis.
5 Deformity varus and valgus.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Five-Times Sit-to-Stand Test
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) |
Baseline AND 6 WEEKS |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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 1 |
|
Date of First Enrollment (India)
|
12/11/2024 |
| 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="3" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
Subjects fulfilling the inclusion and exclusion criteria will be asked to sign the informed consent form. The subjects will be informed in detail about the procedure of the study and will complete the data collection form. Subjects selected for the study will be randomly allocated to two groups— the experimental group i.e., group A, and an even number of participants will be allocated to the control group i.e., group B.Five-Times Sit-to-Stand Test: Measures lower body strength and endurance by timing how long it takes to stand up and sit down five times. Five-time sit-to-stand test- The participant must stand up and sit down five times as quickly as they can without using their hands to propel themselves out of a chair during the five-time STS. A portable stopwatch was used to record the amount of time it took to complete the assignment. A typical armless chair, measuring 43–47 cm in height, was utilized. To maintain stability and safety, the chair’s back ought to be secured against a wall. To avoid using his or her hands, the subject was told to fold his or her arms across his or her chest. The experiment begins when the subject is given the go-ahead by the researcher and ends when the subject, after five repetitions, fully reclines in the chair with his or her back resting against the chair’s back. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a self-administered questionnaire that assesses pain, stiffness, and physical function in patients with hip or knee osteoarthritis. The Western Ontario MacMaster (WOMAC) is a validated instrument designed specifically for the assessment of lower extremity pain and function in osteoarthritis (OA) of the knee . WOMAC, a measure of lower extremity pain (5 items), stiffness (2 items), and function (17 items), with items rated on a Likert scale of 0 (no symptoms) to 4 (extreme symptoms). The reliability and validity of the WOMAC total score and subscales have been confirmed. The WOMAC has been widely used in trials of behavioral interventions for knee OA, confirming its sensitivity to change.
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