| CTRI Number |
CTRI/2024/03/064386 [Registered on: 19/03/2024] Trial Registered Prospectively |
| Last Modified On: |
19/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of thoracic exercise program and mobilization on pulmonary function and kyphosis angle in hyperkyphosis |
|
Scientific Title of Study
|
Effect of thoracic exercise program and mobilization on pulmonary function and kyphosis angle in adults with hyperkyphosis : a randomized controlled 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 |
Ridhi Ahuja |
| Designation |
Student |
| Affiliation |
Guru Jambheshwar University of Science and Technology |
| Address |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar
Hisar
HARYANA
125001
India |
| Phone |
8607582637 |
| Fax |
|
| Email |
ahujaridhi20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamta Boora PT |
| Designation |
Assistant Professor |
| Affiliation |
Guru Jambheshwar University of Science and Technology |
| Address |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar
Hisar
HARYANA
125001
India |
| Phone |
8683810061 |
| Fax |
|
| Email |
mamtaboora50@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mamta Boora PT |
| Designation |
Assistant Professor |
| Affiliation |
Guru Jambheshwar University of Science and Technology |
| Address |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar
Hisar
HARYANA
125001
India |
| Phone |
8683810061 |
| Fax |
|
| Email |
mamtaboora50@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ridhi Ahuja BPT Student Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar |
|
|
Primary Sponsor
|
| Name |
Department of Physiotherapy |
| Address |
Guru Jambheshwar University of Science and Technology Hisar Haryana India |
| Type of Sponsor |
Research institution |
|
|
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 Mamta Boora |
Guru Jambheshwar University of Science and Technology |
Room No 05 Department of Physiotherapy OPD GJUS&T
Hisar
HARYANA |
8683810061
mamtaboora50@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee of GJUS&T |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M40-M43||Deforming dorsopathies, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
Patients in this group will perform breathing exercises for three sessions per week for four weeks. |
| Intervention |
Thoracic exercise program with mobilization |
Patients in this group will perform thoracic exercises and will given mobilization for three sessions per week for four weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Kyphosis angle more than 45 degree. |
|
| ExclusionCriteria |
| Details |
1.Patient who are taking some other treatment.
2.Patient with some other severe health condition such as cardiac issues, respiratory problems etc.
3.Patient with congenital musculoskeletal deformity.
4.Patient with pulmonary disease, neurological disorders.
5.Patient with psychological disorders
|
|
|
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 |
Forced expiratory volume in one second
Forced vital capacity |
The outcome will be assessed for two times
which is at the baseline and after the 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Kyphosis Angle |
The outcome will be assessed for two times
which is at the baseline and after the 4 weeks |
|
|
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)
|
27/03/2024 |
| 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="0"
Days="28" |
|
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
|
It is a randomized controlled trial with a duration of 4 weeks and involving 40 patients that will be divided into two groups based on the lottery method. Its intervention involves thoracic exercise program and mobilization in one group and breathing exercises in control group.The patients will be informed about the study and written informed consent will be taken. First, each patient’s demographic information including age, height and weight will be gathered as a baseline data. Pre-intervention measurements of outcome variables including Kyphosis angle, Forced expiratory volume in one second (FEV1) and Forced vital capacity (FVC) will be taken. Interventions will be given for 4 weeks then Post-intervention data of all outcome variables will taken. |