| CTRI Number |
CTRI/2021/01/030538 [Registered on: 18/01/2021] Trial Registered Prospectively |
| Last Modified On: |
17/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Observational Comparative |
| Study Design |
Other |
|
Public Title of Study
|
Pulmonary Functions in Young Adults with and without Forward Head Posture |
|
Scientific Title of Study
|
Comparison of Pulmonary Functions in Young Adults with and without Forward Head Posture |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jaimala V Shetye |
| Designation |
Associate Professor |
| Affiliation |
P.T. School and Centre Seth GS Medical College and KEM Hospital |
| Address |
Cardiorespiratory Physiotherapy and Health promotion and fitness department, P.T. School and Centre Seth GS Medical College and KEM Hospital, Acharya Dhonde Marg, Parel (E), Mumbai-12
Mumbai (Suburban)
MAHARASHTRA
400012
India |
| Phone |
02224143435 |
| Fax |
|
| Email |
jaimalavs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jaimala V Shetye |
| Designation |
Associate Professor |
| Affiliation |
P.T. School and Centre Seth GS Medical College and KEM Hospital |
| Address |
P.T. School and Centre Seth GS Medical College and KEM Hospital, Acharya Dhonde Marg, Parel (E), Mumbai-12
Mumbai (Suburban)
MAHARASHTRA
400012
India |
| Phone |
02224143435 |
| Fax |
|
| Email |
jaimalavs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mohini Kamat |
| Designation |
Postgraduate Student MPT |
| Affiliation |
P.T. School and Centre Seth GS Medical College and KEM Hospital |
| Address |
P.T. School and Centre,Seth GS Medical College and KEM Hospital, Acharya Dhonde Marg, Parel (E), Mumbai-12
Mumbai (Suburban)
MAHARASHTRA
400012
India |
| Phone |
02224143435 |
| Fax |
|
| Email |
faramireowyn.mk@gmail.com |
|
|
Source of Monetary or Material Support
|
| P.T. School and Centre, Seth GS Medical College and KEM Hospital |
|
|
Primary Sponsor
|
| Name |
Jaimala V Shetye |
| Address |
P.T. School and Centre,Seth GS Medical College and KEM Hospital, Acharya Dhonde Marg, Parel (E), Mumbai-12 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Jaimala V Shetye |
Seth GS Medical College and KEM Hospital |
P.T. School and Centre,Seth GS Medical College and KEM Hospital, Acharya Dhonde Marg, Parel (E), Mumbai-12
Mumbai (Suburban)
MAHARASHTRA |
02224143435
jaimalavs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Seth GS Medical College and KEM Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Forward Head Posture |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
FOR GROUP A( WITH FORWARD HEAD POSTURE)
1. Craniovertebral angle less than 50 degrees
2. Non exercising Individuals
3. All individuals with normal body mass index (BMI 18.50 – 24.99 kg/m2)
FOR GROUP B (WITHOUT FORWARD HEAD POSTURE)
1. Craniovertebral angle more than or equal to 50 degrees
2. Non exercising Individuals
3. All individuals with normal BMI between (18.50 – 24.99 kg/m2)
|
|
| ExclusionCriteria |
| Details |
1. Individuals refusing consent
2. History of smoking, Alcohol use Disorder ( Defined as - A problematic pattern of alcohol use leading to clinically significant impairment or distress manifested by at least 2 of criteria as specified by DSM occurring within a 12 month period) and tobacco consumption
3. H/o trauma to the Cervical spine, thoracic spine and shoulders
4. Degenerative changes of the spine and neurological conditions
5. Known cardiovascular disorders and respiratory disorders.
6. H/o cervical and thoracic surgeries, rib fractures
7. Pregnant women
8. Individuals with neck pain
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pulmonary Functions by Single Breath Count and Chest Expansion |
Single time assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
20/01/2021 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Forward Head Posture is a postural deviation associated with adverse effects on many body systems. It is prevalent in young adults with sedentary jobs. Craniovertebral angle is a common method to assess the degree of Forward Head Posture. Vital Capacity is the volume of air mobilized between a maximal inspiratory maneuver and a maximal expiratory maneuver(ATS). Vital Capacity is measured either by a Forced maneuver (FVC) or a slow maneuver (SVC). It is the primary indicator of lung volume. FEV1 is the volume of air expired in the first second of forced expiration and it is influenced by lung volume and airflow obstruction. Single Breath Count (SBC) is the measure of lung function in terms of how far an individual can count in a normal voice after maximal effort inhalation. It has good correlation with FEV1, FVC and SVC, thus an estimate of lung volumes and pulmonary functions. Chest expansion is the measure of rib cage mobility. Forward head posture can compromise rib cage mobility and thereby lung functions, because of the misalignment of the cervical, thoracic spine and ribs. Hence, chest expansion is taken as an outcome for lung functions. This study will help us to see if there is any difference in Pulmonary Functions in young adults with and without Forward head posture. It is an observational comparative study which will require 25 minutes per subject. Subject fulfilling the inclusion and exclusion criteria will be assessed and their single breath count and chest expansion values will be assessed and noted. Data, if normally distributed, will be analyzed using the Unpaired t test. if not normally distributed, it will be assessed using the Mann Whitney U test. |