The Effect of Inspiratory Muscle Strength Training in Healthy Adults With Forward Head Posture

March 26, 2025 updated by: Gürkan Demirtas, Nigde Omer Halisdemir University

The Effect of Inspiratory Muscle Strength Training on Posture, Respiratory Functions, Respiratory Muscle Strength and Performance in Healthy Adults With Forward Head Posture

Forward head posture (FHP) is defined as the position in which the head is in front of the shoulder and is one of the most common musculoskeletal problems caused by the increasing use of computers and smartphones. Posture analysis, pulmonary function test, respiratory muscle strength and endurance assessment, and performance test will be performed as the initial evaluation for those who meet the inclusion criteria and volunteer to participate in the study. Participants with a craniovertebral angle of 50 degrees and less than 50 degrees will be included in the head forward posture (FHP, n=34) group, and participants with an angle of more than 50 degrees will be included in the control group (CG, n=34).Participants with HFP will be randomly divided into two groups as study (FHP-S, n=17) and control (FHP-C, n=17). An inspiratory muscle strength training program will be applied to the FHP-C group for 7 days/6 weeks. All assessments performed before the training will be repeated after 6 weeks of inspiratory muscle strength training. No inspiratory muscle strength training will be applied to the FHP-C group. Participants in the CG group will not undergo any additional assessment or training.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Forward head posture (FHP) is defined as the position in which the head is in front of the shoulder and is one of the most common musculoskeletal problems caused by the increasing use of computers and smartphones. Posture analysis, pulmonary function test, respiratory muscle strength and endurance assessment, and performance test will be performed as the initial evaluation for those who meet the inclusion criteria and volunteer to participate in the study. Participants with a craniovertebral angle of 50 degrees and less than 50 degrees will be included in the head forward posture (FHP, n=34) group, and participants with an angle of more than 50 degrees will be included in the control group (CG, n=34).Participants with HFP will be randomly divided into two groups as study (FHP-S, n=17) and control (FHP-C, n=17). An inspiratory muscle strength training program will be applied to the FHP-C group for 7 days/6 weeks. All assessments performed before the training will be repeated after 6 weeks of inspiratory muscle strength training. No inspiratory muscle strength training will be applied to the FHP-C group. Participants in the CG group will not undergo any additional assessment or training.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • Niğde, Turkey, 51200
        • Niğde Ömer Halisdemir Üniversitesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Cranio-vertebral angle (CVA) of 50 degrees and less than 50 degrees

Exclusion Criteria:

  • Diagnosed respiratory, neurological, orthopedic, psychiatric or cardiac problems
  • Have any infection at the time of assessment and training,
  • Having any limitation that prevents assessment and training
  • Pregnancy or breastfeeding
  • Having a history of neck trauma
  • Having undergone lumbar-neck surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Forward head posture-Study
participants with a forward head posture who will undergo an exercise program
Other: Exercise
Inspiratory muscle strength training program will be applied to the FHP-C group for 7 days/6 weeks.
No Intervention: Forward head posture-Control
participants with forward head posture who will not perform an exercise program
No Intervention: Control group
control group without forward head posture

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Craniovertebral angle
Time Frame: Baseline
Where a line drawn from the tragus of the ear to the C7 vertebra intersects a horizontal line, the CV angle is formed.
Baseline
Sagittal head tilt
Time Frame: Baseline
This angle, which is formed between a line from the canthus of the eye and the tragus of the ear and the horizontal, is a measure of the posture of the upper cervical spine.
Baseline
Sagittal shoulder-C7 angle
Time Frame: Baseline
Where a horizontal line passing through the lateral shoulder meets the line drawn from C7 to the lateral shoulder, the point of intersection forms the sagittal shoulder-C7 angle
Baseline
Kyphosis angle measurement
Time Frame: Baseline
The spinous processes of C7 and T12 vertebrae will be marked by a marker (reflector). Extensions of these reflectors will be taken and perpendicular lines will be drawn to these extensions. The angle formed by the intersection of the perpendicular lines will be measured as the thoracic kyphosis angle
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pulmonary Function Tests- FEV1/FVC
Time Frame: Baseline
Evaluation of FEV1/FVC ratio MicroQuark® computer-based USB spirometer will be used to assess the respiratory function of the participants. The person will be asked to take a few normal breaths followed by as deep a breath as possible and instructed to exhale forcefully and quickly without waiting. The test will be terminated by instructing the participant to take a deep breath after exhaling for at least six seconds.
Baseline
Pulmonary Function Tests- FVC
Time Frame: Baseline
Evaluation of Forced Vital Capacity (FVC) MicroQuark® computer-based USB spirometer will be used for FVC evaluation. The person will be asked to take a few normal breaths, then take as deep a breath as possible, and then exhale forcefully and quickly without waiting. The test will be terminated by instructing the participant to take a deep breath after exhaling for at least six seconds.
Baseline
Pulmonary Function Tests- FEV1
Time Frame: Baseline
Evaluation of Forced Expiratory Volume in 1 second (FEV1) MicroQuark® computer-based USB spirometer will be used for FEV1 evaluation. The person will be asked to take a few normal breaths, then take as deep a breath as possible, and then exhale forcefully and quickly without waiting. The test will be terminated by instructing the participant to take a deep breath after exhaling for at least six seconds.
Baseline
Pulmonary Function Tests- PEF
Time Frame: Baseline
Evaluation of Peak Expiratory Flow (PEF) MicroQuark® computer-based USB spirometer will be used for PEF evaluation. The person will be asked to take a few normal breaths, then take as deep a breath as possible, and then exhale forcefully and quickly without waiting. The test will be terminated by instructing the participant to take a deep breath after exhaling for at least six seconds.
Baseline
Pulmonary Function Tests- MVV
Time Frame: Baseline
Maximum voluntary ventilation (MVV) MicroQuark® computer-based USB spirometer will be used for MVV evaluation. Then the participant will take the disposable bacteria filter mouthpiece between his lips and holds it tightly. The person will be asked to deeply and rapidly breaths for 10 to 15 seconds.
Baseline
Respiratory Muscle Strength
Time Frame: Baseline
During the measurements, the nose of the individual participating in the study will be covered with a nose clip. During the maximal inspiratory pressure (MIP) measurement, the participants will be asked to inspire quickly and deeply with maximum effort after maximum expiration. For maximal expiratory pressure (MEP), the participant will be asked to expire quickly and deeply after maximum inspiration.
Baseline
Sport performance
Time Frame: Baseline
Subjects run back and forth on a 20 m course and must touch the 20 m line; at the same time a sound signal is emitted from a prerecorded tape. Frequency of the sound signals is increased 0.5 km h-1 each minute from a starting speed of 8.5 km h-1. When the subject can no longer follow the pace, the test is stopped.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nigde Omer Halisdemir University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Gazi University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Nevin A. Güzel, Prof. Dr., Gazi University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 27, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 27, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 2, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 25, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 28, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024 - 41

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings