| CTRI Number |
CTRI/2024/11/076325 [Registered on: 06/11/2024] Trial Registered Prospectively |
| Last Modified On: |
05/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Comparing uphill walking and aerobic exercise for knee pain relief in osteoarthritis patients. |
|
Scientific Title of Study
|
Effect of Uphill walking vs Aerobic exercise on Functional capacity and Pain in subjects with grade 2&3 knee osteoarthritis: A Randomised clinical 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 Ganesh B R |
| Designation |
Professor and Head of CVTS department |
| Affiliation |
KLE Institute of Physiotherapy , professor and head of department of CVTS |
| Address |
Advanced Physiotherapy center OPD no:39, CVTS department,Room no: 06, Sagar floor KLEs Dr Prabhakar Kore Hospital and MRC Nehrunagar Belagavi-590010 Karnataka India.
Belgaum
KARNATAKA
590010
India |
| Phone |
9844857581 |
| Fax |
|
| Email |
ganeshbr@klekipt.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ganesh B R |
| Designation |
Professor and Head of CVTS department |
| Affiliation |
KLE Institute of Physiotherapy,Belagavi. Professor and head of CVTS department |
| Address |
Advanced Physiotherapy center OPD no:39, CVTS department,Room no: 06, Sagar floor KLEs Dr Prabhakar Kore Hospital and MRC Nehrunagar Belagavi-590010 Karnataka India.
Belgaum
KARNATAKA
590010
India |
| Phone |
9844857581 |
| Fax |
|
| Email |
ganeshbr@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Bradley Carvalho |
| Designation |
Physiotherapy Intern |
| Affiliation |
KLE Institute of Physiotherapy Belagavi |
| Address |
Advanced Physiotherapy center OPD no:39, CVTS department,Room no: 06, Sagar floor KLEs Dr Prabhakar Kore Hospital and MRC Nehrunagar Belagavi-590010 Karnataka India.
Belgaum
KARNATAKA
590010
India |
| Phone |
7721826957 |
| Fax |
|
| Email |
bradleycarvalho123456789@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLEs Dr. Prabhakar Kore Hospital and MRC, Nehrunagar Belagavi-590010, Karnataka India. |
|
|
Primary Sponsor
|
| Name |
KAHER Institute of Physiotherapy |
| Address |
KAHER Institute of Physiotherapy, JNMC Campus, Nehru nagar,Belagavi-590010, Karnataka India. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Charu Kashyap |
KLES Dr. Prabhakar Kore Hospital and M.R.C. |
Advanced Physiotherapy center, OPD no:39,Department of CVTS room no:06, Sagar floor Belagavi-590010, Karnataka India.
Belgaum
KARNATAKA |
6203375202
Charukashyap2002@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Scientific and Ethics committee, KLEU Institute of Physiotherapy |
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 |
(Group A) Uphill walking along with conventional exercises. |
(Group A) UPHILL WALKING
10 sessions of 30 mins each.
3 times a week for 4 weeks
1.Warm-up: 2 mins at 0-degree slope
2.Inclined walking: 15 mins at 8-degree incline
3.Cool-down period
Conventional exercises 10 mins:Mini squats, heel slides, dynamic quads, single leg raises, quadriceps stretch and Hamstring stretch.
Total duration- 4 weeks 10 sessions ( 300 mins ) |
| Comparator Agent |
(Grpup B) Aerobic strengthening exercises along with conventional exercises. |
(Group B) Aerobic strengthening exercises
10 sessions of 30 mins each
3times a week for 4weeks
Exercises:
1.Seated marching (3x10)
2.Seated leg extension (3x10)
3.Calf raises (3x10)
4.Tandem walking 5mins
5.Walking for 10 mins
Conventional exercises 10 mins:
Mini squats, heel slides, dynamic quads, single leg raises, quadriceps stretch and Hamstring stretch.
Total duration- 4 weeks 10 sessions (300 mins) |
|
|
Inclusion Criteria
|
| Age From |
55.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed cases of unilateral knee osteoarthritis grade 2 and 3 based on Kellegren and Lawrence classification. Knee pain ranging between 2-7/10 on VAS scale. Subjects having knee pain from 3 weeks to 2 months. |
|
| ExclusionCriteria |
| Details |
Undergone recent surgical intervention ,fractutes in lower limbs. Any Neuropathies, Neurological conditions, cardiac conditions or ulcers in lower limbs |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate functional capacity using 6 minute walk test and Pain using Numerical Pain Rating Scale (VAS) . |
At Baseline and at 4 weeks. |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
16/11/2024 |
| 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="90"
Months="0"
Days="3" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The subjects will be recruited on the basis of inclusion and exclusion criteria. The recruited individuals will be tested for the functional capacity using 6 minutes walk test and pain using numerical pain rating scale, the participants will be given an intervention i.e Group A: warm up, inclined walking, and cool down Group B: aerobic strengthening exercises, seated marching, seated heel leg extension, calf raises, tandem walking and walking. Four week intervention three times a week. After the intervention completes post outcome measures will be assessed |