| CTRI Number |
CTRI/2021/08/035520 [Registered on: 09/08/2021] Trial Registered Prospectively |
| Last Modified On: |
10/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic
Screening
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Impact of Exercise Protocol through Telerehabilitation in Post COVID Patients. |
|
Scientific Title of Study
|
Impact of Exercise Protocol through Telerehabilitation in Post COVID Patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Madhuri |
| Designation |
student |
| Affiliation |
GJUST Hisar Haryana |
| Address |
Department of Physiotherapy room no 08 GJUST Hisar Haryana
Department of Physiotherapy room no 08 GJUST Hisar Haryana
Hisar
HARYANA
125001
India |
| Phone |
9350472724 |
| Fax |
|
| Email |
madhurisaini671@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vandana Rani |
| Designation |
Assistant Professor |
| Affiliation |
GJUST Hisar Haryana |
| Address |
Department of Physiotherapy room no 101 GJUST Hisar Haryana
Department of Physiotherapy room no 101 GJUST Hisar Haryana
Hisar
HARYANA
125001
India |
| Phone |
9034627420 |
| Fax |
|
| Email |
dr.vandanaravi7@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vandana Rani |
| Designation |
Assistant Professor |
| Affiliation |
GJUST Hisar Haryana |
| Address |
Department of Physiotherapy room no 101 GJUST Hisar Haryana
Department of Physiotherapy room no 101 GJUST Hisar Haryana
Hisar
HARYANA
125001
India |
| Phone |
9034627420 |
| Fax |
|
| Email |
dr.vandanarani7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, GJUST, Hisar-125001 Haryana , India |
|
|
Primary Sponsor
|
| Name |
Madhuri |
| Address |
Department of Physiotherapy, GJUST, Hisar-125001 Haryana , India |
| Type of Sponsor |
Other [Self Funding] |
|
|
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 |
| Madhuri |
Guru Jambeshwar University of Health Science and Technology |
Health Center Room no.08 Ground floor
Hisar
HARYANA |
9350472724
madhurisaini671@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Department of physiotherapy GJUST Hisar Haryana |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
control group |
participants were instructed to do for atleast 10 minutes per days. |
| Intervention |
Experimental group |
The total of 30 minutes exercises that included combination of strengthening and stretching exercise for both limbs and breathing exercises for respiratory tract for alternate days/4 weeks through telerehabilitation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1) Age 18- 75 years.
2) Patient who are affected with corona virus and are in home confinent.
3) Having at least one r-T-PCR COVID report.
4) Ability to walk.
5) Ability to use smartphone.
6) Patient likely to benefit from on call physiotherapy.
7) Controlled asthma with evidence of infection, retained secretion, increase work of breathing.
|
|
| ExclusionCriteria |
| Details |
1) Patients with chronic lung disease, kidney disease, neurological disorder.
2) Patients affected with acute phase of disc abnormalities.
3) Patients who have had respiratory conditions in the last 12 months.
4) Patients who have recent musculoskeletal disorders and who are not fully recovered from their injuries.
5) Viral pneumonia.
6) Uncooperative patients.
7) Uncontrolled bronchospasm.
8) Pregnancy and lactating mothers.
9) Red flags for serious conditions (night pain, severe muscle spasm, loss of involuntary weight, symptoms mismatch).
10) Their disease in which exercise is unsuitable.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
physical performance
lower limb strength
health related quality of life |
Baseline
4 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Dyspnea |
Baseline
4 weeks
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
12/08/2021 |
| 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) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
COVID-19 can cause serious damage to the respiratory tract, often resulting in muscle weakness, shortness of breath, polyneuritis and multi organ failure. Physical therapy plays a fundamental role in restoring function and quality of life. Tele-rehabilitation is being proposed as a promising complementary therapy to conventional physical therapy. The main objective of this study was to evaluate the impact of exercise protocol through tele-rehabilitation in post COVID patients. Post discharge screening intervention to improve functional abilities and quality of life in relation to treatment in health education programs and rehabilitation centers. With secondary purposes, tele-rehabilitation programs determine patient satisfaction and perceptions and the presence of its implementation, as well as to evaluate the cost effectiveness from the perspective of health system. |