NCT06131164

Brief Summary

The main objective of this study is to find the effects of breathing exercises on cardiorespiratory parameters in subjects with forward head posture. This will be a Randomized Clinical Trial study with two different breathing exercises which include Diaphragmatic Breathing Exercise (DBE) for Treatment group A individuals and Thoracic Extension Exercise (TEE) for Treatment Group B individuals will be performed along with ergometric advices. Each exercise session will be done three times per week for total over a period of 12 weeks. Outcomes will be measured at baseline, 6th and 12th week with photogrammetry method for craniovertebral angle (CVA) and spirometer for pulmonary function test values (PFTs).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 30, 2023

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 14, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
Last Updated

April 19, 2024

Status Verified

April 1, 2024

Enrollment Period

3 months

First QC Date

November 9, 2023

Last Update Submit

April 18, 2024

Conditions

Keywords

Forward Head PostureDiaphragmatic breathing exerciseThoracic Extension ExerciseCardiorespiratory parametersCraniovertebral Angle

Outcome Measures

Primary Outcomes (4)

  • Photogrammetry Method for Forward Head Posture Assessment

    Photogrammetry is a reliable and accurate tool for measurement of angles. It is used to measure the FHP through measurement of Craniovertebral angle (CVA) measurement. CVA is the inner angle between the horizontal line drawn from C7 spinous process to the midpoint of the tragus. As the higher the CVA the higher the FHP. All measurements are done after taking a photograph via digital camera in lateral-view in standing position

    Baseline; 6th Week; 12th Week

  • Spirometry for Pulmonary Function Test FEV1

    Spirometry method is use to measure pulmonary functions by assessing the lung volumes and capacities. As these pulmonary values will changed after FHP as the mobility of cervical spine and diaphragm are compromised. Spirometry is a cost effect, environment friendly, noninvasive and sensitive tool which can easily help in assessment of pulmonary function

    Baseline; 6th Week; 12th Week

  • Spirometry for Pulmonary Function Test FVC

    Spirometry method is use to measure pulmonary functions by assessing the lung volumes and capacities. As these pulmonary values will changed after FHP as the mobility of cervical spine and diaphragm are compromised. Spirometry is a cost effect, environment friendly, noninvasive and sensitive tool which can easily help in assessment of pulmonary function

    Baseline; 6th Week; 12th Week

  • Spirometry for Pulmonary Function Test FEV1/FVC ratio

    Spirometry method is use to measure pulmonary functions by assessing the lung volumes and capacities. As these pulmonary values will changed after FHP as the mobility of cervical spine and diaphragm are compromised. Spirometry is a cost effect, environment friendly, noninvasive and sensitive tool which can easily help in assessment of pulmonary function

    Baseline; 6th Week; 12th Week

Study Arms (2)

Diaphragmatic Breathing Exercise Group

EXPERIMENTAL

This group will perform baseline treatment along with balloon breathing exercises also known as diaphragmatic breathing exercise for pulmonary function improvement and FHP Diaphragmatic breathing is done slowly and deeply through nose with minimum usage of chest movement. Only diaphragm is used for breathing in supine lying position with one hand placed on chest and other hand is placed on abdomen. Focus should be on the contraction of diaphragm that can be checked by hand placed on abdomen while there is as little movement in chest as possible which is also checked by hand placed on chest. Inhalation and exhalation should be for 6 second approximately. Each exercise session consist of 4 sets and each set has 4 complete breathing breaks. Will be done 2 times a day and 3 times per week for total of 8 weeks.

Other: Diaphragmatic Breathing Exercise Group

Thoracic Extension Exercise Group

ACTIVE COMPARATOR

This group along with baseline treatment will do Thoracic Extension Exercises (TEE) for FHP and Pulmonary function improvements. This is done in 3 steps. The restricted upper thoracic area is placed on foam roller with subject lying supine with knees flexed, buttock slightly lifted up from the floor and crossed hands on the chest. Roll the foam roller slightly up and down. Swiss ball is place in front of the subject who is sitting with knees flexed and then the ball is pushed slightly forward with both hands placed on it. While lying prone lift up and then pushing down the upper body while the upper body is supported by elbows places just below shoulders. All these steps will be followed by 2 sets of 15 repetitions and holding 10 sec for each repetition.

Other: Thoracic Extension Exercise Group

Interventions

The subjects in this group will perform Diaphragmatic Breathing Exercise Group

Diaphragmatic Breathing Exercise Group

The subjects in this group will perform Thoracic Extension Exercise Group

Thoracic Extension Exercise Group

Eligibility Criteria

Age30 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Both Males and Females are included
  • Age group: Middle age adult from 30 to 45 years are included
  • Individuals with forward head posture and Craniovertebral Angle \<50o

You may not qualify if:

  • Previous history of neck or back surgery or neurological signs
  • Psoriatic arthritis or rheumatoid arthritis
  • Currently using muscle relaxation medication
  • Cervical fracture, trauma or tumor
  • Unstable cardiac condition
  • Undergone any thoracic or abdominal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah Rehabilitation Clinic

Lahore, Punjab Province, 54000, Pakistan

Location

Study Officials

  • Danish Hassan, PhD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2023

First Posted

November 14, 2023

Study Start

October 30, 2023

Primary Completion

January 30, 2024

Study Completion

February 28, 2024

Last Updated

April 19, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations