| CTRI Number |
CTRI/2025/08/092266 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
01/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Studying How Muscle-Lengthening, Muscle-Shortening, and Static Leg Exercises Affect Knee Function in People with Knee Osteoarthritis |
|
Scientific Title of Study
|
Comparative Effects of Isometric, Concentric, and Eccentric Contraction Exercises on Knee Function in Individuals with Knee Osteoarthritis: A Quasi-Experimental Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mr YESHWANTH S S |
| Designation |
Under graduate |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research[Deemed to be university] |
| Address |
Faculty of Physiotherapy, Room No 4.3, Floor 4, Sri Ramachandra
Institute of Higher Education and Research[Deemed to be university],Porur,Chennai-600116,Tamil Nadu, India.
Chennai
TAMIL NADU
600116
India |
| Phone |
08072360123 |
| Fax |
|
| Email |
t0121074@sriher.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DR K SOUNDARARAJAN |
| Designation |
Assistant Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research[Deemed to be university] |
| Address |
Faculty of Physiotherapy, Room No 2.3, Floor 2, Sri Ramachandra
Institute of Higher Education and Research[Deemed to be university],Porur,Chennai-600116,Tamil Nadu, India.
Chennai
TAMIL NADU
600116
India |
| Phone |
9551163416 |
| Fax |
|
| Email |
soundararajan.k@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
DR K SOUNDARARAJAN |
| Designation |
Assistant Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research[Deemed to be university] |
| Address |
Faculty of Physiotherapy, Room No 2.3, Floor 2, Sri Ramachandra
Institute of Higher Education and Research[Deemed to be university],Porur,Chennai-600116,Tamil Nadu, India.
TAMIL NADU
600116
India |
| Phone |
9551163416 |
| Fax |
|
| Email |
soundararajan.k@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Faculty of Physiotherapy, Sri Ramachandra
Institute of Higher Education and Research[Deemed to be university], Porur, Chennai-600116, Tamil Nadu, India |
|
|
Primary Sponsor
|
| Name |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Faculty of Physiotherapy, Room No 4.3, Floor 4, Sri Ramachandra
Institute of Higher Education and Research[Deemed to be university],Porur,Chennai-600116,Tamil Nadu, India. |
| 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 |
| DR K SOUNDARARAJAN |
Sri Ramachandra Hospital |
New Block Physiotherapy OPD, ground Floor , Room No 1, Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research[Deemed to be university], Porur, Chennai-600116, Tamil Nadu,India
Chennai
TAMIL NADU |
9551163416
soundararajan.k@sriramachandra.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Students Project, Faculty of Physiotherapy,Sri Ramachandra Institute of Higher Education and Research[Deemed to be university], Porur, Chennai- 600116, Tamil Nadu, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Concentric group |
seated knee extension with/without resistance.
step up exercise.
prone hamstring curls.
Frequency 4-5 times per week, Duration : 10-15 minutes |
| Intervention |
Eccentric group |
step down
wall sit
terminal knee extension
Frequency 4-5 times per week, Duration : 10-15 minutes |
| Comparator Agent |
isometric group |
quadriceps hold
hamstring hold
straight leg raise hold
half squat
Frequency 4-5 times per week, Duration : 10-15 minutes |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Individuals clinically diagnosed with unilateral or bilateral Knee OA (Kellgren–Lawrence grade I to II).
Age more than 45 years including both men and women.
Individuals can walk independently without any assistive devices.
NPRS less than 8 score.
|
|
| ExclusionCriteria |
| Details |
Healthy people.
People with walking aids.
Individuals who have medical impairments that affect their ability to walk.
Participants who are unable to understand or follow instructions due to cognitive impairments or language barriers.
Pain Score more than 8 in NPRS.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. 6-minute walk test
2. Handheld dynamometer
3. TUG test |
at baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NPRS |
at baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
14/08/2025 |
| 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="0"
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
|
Background:
Knee Osteoarthritis (OA) is a common degenerative joint disorder that
leads to pain, reduced mobility, and impaired functional capacity. Exercise
therapy is a cornerstone of non-pharmacological management for OA. However, the
differential effects of specific muscle contraction types—isometric,
concentric, and eccentric—on knee function remain under-investigated.
Understanding the optimal contraction modality could help refine rehabilitation
strategies for improved clinical outcomes.
Aim
This study compares the effects of isometric,
concentric, and eccentric exercises on knee function in individuals with knee
osteoarthritis, focusing on pain, mobility, strength, and quality of life.
OBJECTIVE:
To compare the effects of isometric, concentric, and eccentric
quadriceps exercises on pain, mobility, and functional performance in
individuals with Knee OA and to identify the most effective contraction
modality for improving overall knee function.
Procedure:
Institutional Ethical Committee, SRIHER will be obtained,
and the Study will be registered in the Clinical Trial Registry of India. The
participants will be screened for eligibility criteria. Once the participant
fulfils the inclusion criteria, informed consent will be obtained, and all the
baseline assessments will be done for both knee Osteoarthritis individuals. Participants
will be allocated into three intervention groups (n=15 per group).
·
Isometric Group: Static quadriceps holds
·
Concentric Group: Active knee extension
exercises
·
Eccentric Group: Controlled knee flexion under
resistance.
All groups will undergo supervised exercise sessions, 3 times per week
for 8 weeks. Baseline and post-intervention measurements will be taken. |