| CTRI Number |
CTRI/2024/04/066103 [Registered on: 23/04/2024] Trial Registered Prospectively |
| Last Modified On: |
18/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Decreasing Pain, Improving Muscle Strength and Quality of Life For OA Knee Patients Using Hydrotherapy and Progressive Resistance Exercises |
|
Scientific Title of Study
|
Effects of Hydrotherapy Versus Progressive Resistance Exercise in Patients With Primary Tibiofemoral Osteoarthritis of Knee in Decreasing Pain, Improving Muscle Strength and Quality of Life |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kavya M |
| Designation |
MPT orthopaedic student |
| Affiliation |
The Tamilnadu Dr M G R Medical University |
| Address |
Sri Ramakrishna Institute of Paramedical Sciences Room no 4017 Division of Orthopaedics Physiotherapy #395 Sarojini Naidu Road Sidhapudur Coimbatore
Tamil Nadu 641044
India
Coimbatore
TAMIL NADU
641044
India |
| Phone |
8608268905 |
| Fax |
|
| Email |
kavyamohankumar25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof VS Seetharaman |
| Designation |
Principal |
| Affiliation |
Sri Ramakrishna Institute of Paramedical Sciences |
| Address |
Sri Ramakrishna Institute of Paramedical Sciences Room no 4017 Division of Physiotherapy #395 Sarojini Naidu Road Sidhapudur Coimbatore
Tamilnadu 641044
India
Coimbatore
TAMIL NADU
641044
India |
| Phone |
9842744406 |
| Fax |
|
| Email |
seeraman_vs@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof V S Seetharaman |
| Designation |
Principal |
| Affiliation |
Sri Ramakrishna Institute of Paramedical Sciences |
| Address |
Sri Ramakrishna Institute of Paramedical Sciences Room no 4017 Division of Physiotherapy #395 Sarojini Naidu Road Sidhapudur Coimbatore
Tamilnadu 641044
India
TAMIL NADU
641044
India |
| Phone |
9842744406 |
| Fax |
|
| Email |
seeraman_vs@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramakrishna Institute of Paramedical Sciences Room no 4017 Division of Orthopaedics Physiotherapy #395 Sarojini Naidu Road Sidhapudur Coimbatore
Tamil Nadu 641044
India |
|
|
Primary Sponsor
|
| Name |
Kavya M |
| Address |
Sri Ramakrishna Institute of Paramedical Sciences Room no 4017 Division of Orthopaedics Physiotherapy #395 Sarojini Naidu Road Sidhapudur Coimbatore
Tamil Nadu 641044
India |
| Type of Sponsor |
Other [Self] |
|
|
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 V S Seetharaman PT |
Sri Ramakrishna Multi Speciality Hospital |
Sri Ramakrishna Institute of Paramedical Sciences Room no 4017 Division of Orthopaedics Physiotherapy #395 Sarojini Naidu Road Sidhapudur Coimbatore
Tamil Nadu 641044
India
Coimbatore
TAMIL NADU |
9842744406
principal@sriramakrishnacollegeofphysiotherapy.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramakrishna hospital ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
hydrotherapy |
40 minutes of treatment duration for alternate days for 6 weeks for each subects |
| Comparator Agent |
progressive resistance exercise |
40 minutes of treatment duration for alternate days for 6 weeks for each subects |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Mild and moderate primary tibiofemoral osteoarthritis of knee according to Kellgren and Lawrence classification
Male and female
Unilateral primary tibiofemoral OA of knee
Age group 45 to 55 years
|
|
| ExclusionCriteria |
| Details |
Hydrophobia
Lower limb joint replacement
Recent trauma in lower limb
Using any walking support and inability to walk
Open wounds
Skin infection
Urinary or fecal incontinence
Neurological disease
Psychiatric disorder
Epilepsy
Knee deformities
Spinal surgeries
Limb shortening
ACL injuries and reconstruction
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Decreasing Pain
Improving Muscle Strength
Quality of Life |
At baseline and after 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
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 3 |
|
Date of First Enrollment (India)
|
02/05/2024 |
| 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="8"
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
|
Effects of Hydrotherapy Versus Progressive Resistance Exercise in Patients With Primary Tibiofemoral Osteoarthritis of Knee in Decreasing Pain, Improving Muscle Strength and Quality of Life
Introduction The prevalence of OA increases with age and eventually leads to joint stiffness, progressive deformity and functional impairment which in turn negatively affect the individual’s quality of life. The initiation, progression and severity of tibiofemoral knee OA has been associated with decreased muscular strength. Aquatic therapy uses the principles of water, known as hydrodynamics, to cause physiological changes. These principles are buoyancy, density, viscosity, thermodynamics and hydrostatic pressure which act together to give the patient a unique sensory experience to facilitate range of motion, functional strength and balance. Resistance training has beneficial effects on musculoskeletal function and body composition, cardiovascular disease, insulin action, bone health, energy metabolism, psychological health and functional status. Aim The aim of the study is to find out the effects of hydrotherapy versus progressive resistance exercise on patients with primary tibiofemoral osteoarthritis of knee in decreasing pain, improving muscle strength and quality of life. Objective The objective of study is to compare the effects between hydrotherapy and progressive resistance training in primary tibiofemoral osteoarthritis of knee in decreasing pain, improving muscle strength and quality of life. Methodology Group A Hydrotherapy and Group B Progressive resistance exercise. 6 weeks for alternative days Results Results will be drawn after statistical analysis.
|