| CTRI Number |
CTRI/2023/10/058743 [Registered on: 17/10/2023] Trial Registered Prospectively |
| Last Modified On: |
17/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
A study to see the effect of aerobic exercise and breathing exercise on energy expenditure and aerobic capacity in patients with knee osteoarthritis. |
|
Scientific Title of Study
|
Effect of aerobic exercise and breathing exercise on energy expenditure and aerobic capacity in patients with knee osteoarthritis. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manisha |
| Designation |
PG Student |
| Affiliation |
COLLEGE OF PHYSIOTHERAPY, E-BLOCK, Pt. BD SHARMA UNIVERSITY of HEALTH SCIENCES, ROHTAK |
| Address |
COLLEGE OF PHYSIOTHERAPY, E-BLOCK,
Pt. BD SHARMA UNIVERSITY of HEALTH SCIENCES, ROHTAK
Rohtak
HARYANA
124001
India |
| Phone |
9991261785 |
| Fax |
|
| Email |
dangi11manisha22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Suman |
| Designation |
Assistant Professor |
| Affiliation |
COLLEGE OF PHYSIOTHERAPY, E-BLOCK, Pt. BD SHARMA UNIVERSITY of HEALTH SCIENCES, ROHTAK |
| Address |
COLLEGE OF PHYSIOTHERAPY, E-BLOCK,
Pt. BD SHARMA UNIVERSITY of HEALTH SCIENCES, ROHTAK
Rohtak
HARYANA
124001
India |
| Phone |
8814063412 |
| Fax |
|
| Email |
sumanmehra2017@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Manisha |
| Designation |
PG Student |
| Affiliation |
COLLEGE OF PHYSIOTHERAPY, E-BLOCK, Pt. BD SHARMA UNIVERSITY of HEALTH SCIENCES, ROHTAK |
| Address |
COLLEGE OF PHYSIOTHERAPY, E-BLOCK,
Pt. BD SHARMA UNIVERSITY of HEALTH SCIENCES, ROHTAK
COLLEGE OF PHYSIOTHERAPY, E-BLOCK,
Pt. BD SHARMA UNIVERSITY of HEALTH SCIENCES, ROHTAK
Rohtak
HARYANA
124001
India |
| Phone |
9991261785 |
| Fax |
|
| Email |
dangi11manisha22@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt. BD SHARMA UNIVERSITY of HEALTH SCIENCES, ROHTAK |
|
|
Primary Sponsor
|
| Name |
College of Physiotherapy, PGIMS, Rohtak |
| Address |
Pt.BD Sharma PGIMS, Rohtak |
| Type of Sponsor |
Government 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 Suman |
College of Physiotherapy |
COLLEGE OF PHYSIOTHERAPY, E-BLOCK,
Pt. BD SHARMA UNIVERSITY of HEALTH SCIENCES, ROHTAK
Rohtak
HARYANA |
8814063412
sumanmehra2017@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee, Pt. BD Sharma PGIMS/UHS Rohtak |
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 |
Aerobic exercise, Breathing exercise |
Uphill treadmill walking for 3 days/week for 4 weeks
Breathing awareness, costal expansion, diaphragmatic breathing for 3 days/week for 4 weeks.
|
| Comparator Agent |
Conventional Physiotherapy |
Hot pack 3 days/week for 4 weeks
Isometric quadriceps 3 days/week for 4 weeks
SLR 3 days/week for 4 weeks
knee extension exercises 3 days/week for 4 weeks
Ankle toe movement 3 days/week for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
Diagnosed cases of knee osteoarthritis (grade II, III on Lawrence kellgren scale).
Subjects with age ≥ 40 years of age.
Both male and female subjects will be included. Subjects who consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
Subjects involved in rehabilitation treatments/corticosteroid injections/surgery (in past 6 months).
Subjects with uncontrolled high BP /other medical condition contraindicating the participation.
Subjects with cognitive impairments.
Subjects with cardio-respiratory and rheumatic disease. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
6-min walk test
Physiological cost index |
at day 0
after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Numerical pain rating scale
SF-36 Questionnaire |
at day 0
after 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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)
|
26/10/2023 |
| 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="1"
Months="0"
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
|
Effect of Aerobic Exercise and Breathing exercise on energy expenditure, aerobic capacity, pain and quality of life in patients with knee osteoarthritis of grade 2,3 on Lawrence kellgren scale. 54 sample size
Inclusion and Exclusion Criteria mentioned above
4 week intervention
Randomized control trial. |