| CTRI Number |
CTRI/2019/02/017735 [Registered on: 20/02/2019] Trial Registered Prospectively |
| Last Modified On: |
15/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
muscle length with lung function in chronic obstructive pulmonary diseases |
|
Scientific Title of Study
|
Correlation of Pectoralis minor and Sternocleidomastiod length with lung function in chronic obstructive pulmonary diseases |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MUKESH KUMAR SINHA |
| Designation |
Assistant Professor |
| Affiliation |
School of Allied Health Sciences,Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, SOAHS, MAHE, MANIPAL
Udupi
KARNATAKA
576104
India |
| Phone |
9535679047 |
| Fax |
|
| Email |
mukesh.sinha@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaishali K |
| Designation |
Professor and Head |
| Affiliation |
School of Allied Health Sciences,Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, SOAHS,MAHE, MANIPAL
Udupi
KARNATAKA
576104
India |
| Phone |
9483929754 |
| Fax |
|
| Email |
vaishali.kh@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaishali K |
| Designation |
Professor and Head |
| Affiliation |
School of Allied Health Sciences,Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, SOAHS,MAHE, MANIPAL
Hassan
KARNATAKA
576104
India |
| Phone |
9483929754 |
| Fax |
|
| Email |
vaishali.kh@manipal.edu |
|
|
Source of Monetary or Material Support
|
| School of Allied Health Science Manipal Academy of Higher Education Manipal District Udupi State Karnataka |
|
|
Primary Sponsor
|
| Name |
School of Allied Health Science Manipal Academy of Higher Education Manipal |
| Address |
School of Allied Health Science Manipal Academy of Higher Education Manipal District Udupi State Karnataka |
| Type of Sponsor |
Private 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 Vaishali K |
Kasturba hospital |
MANIPAL
Udupi
KARNATAKA |
9483929754
vaishali.kh@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
84.00 Year(s) |
| Gender |
Both |
| Details |
Patients with COPD |
|
| ExclusionCriteria |
| Details |
Patients with COPD who are more than 80years of age
Open wounds on the neck or chest
Neck pathologies |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pectoralis Minor Index in cms. Sternocleidomastoid length using bubble inclinometer in degrees
FEV1/ FVC in % |
At the time of recruitment only once |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pectoralis Minor Index in cms. Sternocleidomastoid length using bubble
FEV1/ FVC in % |
At the time of recruitment only once |
|
|
Target Sample Size
|
Total Sample Size="47"
Sample Size from India="47"
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)
|
25/02/2019 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is to check if the muscle tightness (sternocleidomastoid and pectoralis minor) has a relation with disease severity (measured with PFT) in Chronic obstructive pulmonary disease patients. It is important to assess if the disease progression is associated with increased muscle tightness contributing to the worsening dyspnea across disease stages. We hypothesize that the muscle tightness increases as the disease progresses and the resulting increase in abnormal posture and increased dyspnea in COPD. |