| CTRI Number |
CTRI/2022/08/045066 [Registered on: 30/08/2022] Trial Registered Prospectively |
| Last Modified On: |
22/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effects of Thoracic Manipulation in Post COVID-19 Patients |
|
Scientific Title of Study
|
Effects of Thoracic Manipulation on Thoracic Mobility, Ventilatory And Lung Capacity In Post COVID-19 Patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amita Aggarwal |
| Designation |
Associate Professor |
| Affiliation |
Dr. D. Y. Patil College of Physiotherapy |
| Address |
Department of Kinesiology,1st cabin 3rd floor Dr. D. Y. Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
7986972513 |
| Fax |
|
| Email |
amita15pgi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Amita Aggarwal |
| Designation |
Associate Professor |
| Affiliation |
Dr. D. Y. Patil College of Physiotherapy |
| Address |
Department of Kinesiology, 1st cabin 3rd floor Dr. D. Y. Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
7986972513 |
| Fax |
|
| Email |
amita15pgi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aas Chanda |
| Designation |
PG Student |
| Affiliation |
Dr. D. Y. Patil College of Physiotherapy |
| Address |
PG 2 Classroom, 3rd floor Dr. D. Y. Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8200953332 |
| Fax |
|
| Email |
aaschanda@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr D Y Patil College of Physiotherapy Pune |
|
|
Primary Sponsor
|
| Name |
Amita Aggarwal |
| Address |
Department of Kinesiology, 1st cabin 3rd floor Dr. D. Y. Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri, Pune |
| 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 Amita Aggarwal |
Dr. D. Y. Patil College of Physiotherapy, Pune |
Physiotherapy OPD, Basement,
0rtho department, Dr. D. Y. Patil College of Physiotherapy, Pimpri chinchwad Pune.
Pune
MAHARASHTRA |
7986972513
amita15pgi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Dr. D. Y. Patil College of Physiotherapy, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| 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 |
Pulmonary rehabilitation |
Pulmonary rehabiliatation using Respiratory muscle training,breathing exercises,aerobic training and strengthning exercises(total 10 sessions,5 sessions a week for 2 weeks) |
| Intervention |
Thoracic Manipulation and Pulmonary rehabilitation |
Thoracic spine T4–9 Rotation gliding.(total 6 sessions,3 sessions a week in 2 weeks on alternate days)
Pulmonary rehabiliatation using Respiratory muscle training,breathing exercises,aerobic training and strengthning exercises(total 10 sessions,5 sessions a week for 2 weeks) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18-45years
2.Both males and females
3.COVID-19 recovered patients
4.Patients with less than 80% FVC during Pulmonary function test.
|
|
| ExclusionCriteria |
| Details |
1.Thoracic or abdominal surgeries done in last six months
2.Rib or spinal fractures
3.If patients had significant or unstable cardiac and psychological problems
4.Any Spine infections
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Thoracic Mobility
Ventilatory capacity: Chest expansion
Lung capacity: Pulmonary function test.
|
Pre and after 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
Final Enrollment numbers achieved (Total)= "42"
Final Enrollment numbers achieved (India)="42" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/09/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Null Hypothesis (H0) :Thoracic manipulation will have no effect on thoracic mobility, ventilatory and lung capacity in Post COVID patients.
Alternate hypothesis (H1): Thoracic manipulation will have an effect on thoracic mobility, ventilatory and lung capacity in Post COVID patients.
Aims: To study the effect of thoracic manipulation with on thoracic mobility, ventilatory capacity and lung capacity in post COVID patients.
Objectives: To study the effect of thoracic manipulation on thoracic mobility, ventilatory capacity and lung capacity. To study the effect of pulmonary rehabilitation on thoracic mobility, ventilatory capacity and lung capacity. To compare the effect of thoracic manipulation and pulmonary rehabilitation on thoracic mobility, ventilatory capacity and lung capacity. |