FHDNCT06571578
High Intensity Interval Inspiratory Training Effect on Ventilatory Functions and Diaphragmatic Excursion in Forward Head Posture
A study testing Threshold Inspiratory muscle trainer and posture correction exercises in people with FHD, run by Cairo University at 1 site in Egypt.
Trial summary
PURPOSE: ……… The purpose of the study is to investigate the effect of interval inspiratory muscle training on respiratory functions in subjects with forward head posture associated with chronic nonspecific neck pain BACKGROUND: Alteration of head and neck positions can have an immediate negative effect on respiratory… Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- FHD
- What is being tested?
- Threshold Inspiratory muscle trainer and posture correction exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 3 May 2023to 4 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sixty subjects (female) have forward heads and Their craniocervical angle is from 30 to 50°
- Their body mass index ranged from (24.9 -29.9) kg/m2
Who cannot join
- Chest diseases (either obstructive or restrictive).
- Smoker patient.
- Clinical signs of a severe cardiac event. (eg, congestive heart failure),
- Neurological disorders affecting respiratory muscles or any muscular dystrophies (cervical disc or bulge).
- Patient with haemodynamic instability.
Trial locations and contacts
1 site in 1 country.
About this study
PURPOSE: ……… The purpose of the study is to investigate the effect of interval inspiratory muscle training on respiratory functions in subjects with forward head posture associated with chronic nonspecific neck pain
BACKGROUND: Alteration of head and neck positions can have an immediate negative effect on respiratory function. Clinicians should be prompted to assess respiratory function when assessing individuals with FHP and decrease the tension on respiratory system to avoid consequence. Also FHP has a negative effect on chest expansion and diaphragmatic function
Read more
the incidence of forward head posture increases nowadays due to increase using of smartphones HYPOTHESES:: There will be no a significant effect of interval inspiratory muscle training on respiratory functions in chronic forward head posture subjects.
RESEARCH QUESTION: Will the interval inspiratory muscle training improve respiratory functions in subjects forward head posture associated with chronic nonspecific neck pain?
Read the detailed description
- For evaluation: we will assess 1-diaphragmatic excursion using ultrasonography 2- ventilatory functions using spirometer 3- chest expansion using tape measurement 4- height and weight scale to detect BMI 5- Craniocervical angle
- For treatment: we will use 1- threshold inspiratory muscle trainer
And they will be randomly allocated into two groups:
Experimental Group: Thirty subjects will receive combined program containing interval inspiratory muscle training and conventional exercise program for FHP 12 weeks (3 sessions/ week)
Control Group : Twenty subjects will receive conventional exercise program for FHP 12 weeks (3 sessions/ week)
- Conditions
- FHD
- Being tested
- Threshold Inspiratory muscle trainer, posture correction exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Threshold Inspiratory muscle trainerDevice
Also called posture correction exercises
threshold inspiratory muscle trainer device Each subject will breathe through a separate mouthpiece through attach the mouthpiece firmly While putting a nose clip and inhale deeply through the mouthpiece to generate an inspiratory pressure greater than the indicated presetting threshold pressure to compress the spring and open the valve. Using High - intensity interval training technique
posture correction exercisesOther
conventional exercise consists of
- Cervical isometric exercises will be performed in the sitting position by resisting at the forehead (cervical flexion, extension, rotation and side bending) for 10 seconds with 15 seconds breaks between holds with 10-15 repetitions in a progressive manner 3time/week for 12 weeks.
- Postural correction exercise consists of gently rolling of pelvis forward to an upright neutral sitting position, followed by scapular correction and occipital lift. Also, for the sub-occipital muscles stretching
- stretching exercises for scalene and levator muscles
| Study group | Role | What they receive |
|---|---|---|
| exoerimental Group | Experimental | Thirty subjects will receive combined program containing interval inspiratory muscle training and conventional exercise program for FHP 12 weeks (3 sessions/ week). Receives: Device: Threshold Inspiratory muscle trainer; Other: posture correction exercises |
| Control Group | Other | control group Thirty subjects will receive a conventional exercise program for FHP for 12 weeks (3 sessions/ week). Receives: Other: posture correction exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
improve ventilatory functions
measure ventilatory functions in percentage from predictied using spirometery (Digital-CONTEC-SP10-Spirometer-Lung Breathing-Diagnostic (Made in China), to measure ventilatory function test parameters.changes
- Forced expiratory volume in the first second (FEV1)
- Forced vital capacity (FVC).
- FEV1/FVC ratio
- Peak expiratory flow rate (PEFR).
Measured: 3 months
Diaphragmatic execursion
Diaphragmatic sonography model (LOG IQ E10S) for measuring diaphragmatic excursion changes.in centimeter
Measured: 3 months
chest expansion tests
Using tape Measurement tool: To measure chest expansion changes in centimetres at the suprasternal notch, at the nipple and xiphoid levels.
Measured: 3 months
Secondary outcomes (2)
craniocervical angle
- Markings were done with help of Kinovea software. The intersection of a horizontal line passing through C7 spinous process and line joining the midpoint of tragus of ear is known as Craniovertebral angle.
Measured: 3 months
Body mass index
measuring body mass index kg\m2 before measuring ventilatory function test by measuring height in centimetres and body weight in kilograms
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start3 May 2023
- Primary completion1 Aug 2023
- Study completion4 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FHDStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomised control trial (RCT)
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Abd el Maboud Youssef, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06571578
- Sponsor's protocol ID
- IMT for FHS
- Status last verified
- Aug 2024
- First submitted
- 13 Aug 2024
- Last updated
- 26 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Intensity Interval Inspiratory Training Effect on Ventilatory Functions and Diaphragmatic Excursion in Forward Head Posture
- ClinicalTrials.gov ID
- NCT06571578
- Acronym / sponsor ID
- IMT for FHS
- Conditions
- FHD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 3 May 2023 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 4 Feb 2024 (actual)
- First posted
- 26 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
PURPOSE: ……… The purpose of the study is to investigate the effect of interval inspiratory muscle training on respiratory functions in subjects with forward head posture associated with chronic nonspecific neck pain
BACKGROUND: Alteration of head and neck positions can have an immediate negative effect on respiratory function. Clinicians should be prompted to assess respiratory function when assessing individuals with FHP and decrease the tension on respiratory system to avoid consequence. Also FHP has a negative effect on chest expansion and diaphragmatic function
the incidence of forward head posture increases nowadays due to increase using of smartphones HYPOTHESES:: There will be no a significant effect of interval inspiratory muscle training on respiratory functions in chronic forward head posture subjects.
RESEARCH QUESTION: Will the interval inspiratory muscle training improve respiratory functions in subjects forward head posture associated with chronic nonspecific neck pain?
Detailed description
- For evaluation: we will assess 1-diaphragmatic excursion using ultrasonography 2- ventilatory functions using spirometer 3- chest expansion using tape measurement 4- height and weight scale to detect BMI 5- Craniocervical angle
- For treatment: we will use 1- threshold inspiratory muscle trainer
And they will be randomly allocated into two groups:
Experimental Group: Thirty subjects will receive combined program containing interval inspiratory muscle training and conventional exercise program for FHP 12 weeks (3 sessions/ week)
Control Group : Twenty subjects will receive conventional exercise program for FHP 12 weeks (3 sessions/ week)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- randomised control trial (RCT)
| Arm | Type | Receives |
|---|---|---|
| exoerimental Group | Experimental | Device: Threshold Inspiratory muscle trainer, Other: posture correction exercisesThirty subjects will receive combined program containing interval inspiratory muscle training and conventional exercise program for FHP 12 weeks (3 sessions/ week). |
| Control Group | Other | Other: posture correction exercisescontrol group Thirty subjects will receive a conventional exercise program for FHP for 12 weeks (3 sessions/ week). |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Sixty subjects (female) have forward heads and Their craniocervical angle is from 30 to 50°
- Their body mass index ranged from (24.9 -29.9) kg/m2
Key exclusion criteria (5 listed)
- Chest diseases (either obstructive or restrictive).
- Smoker patient.
- Clinical signs of a severe cardiac event. (eg, congestive heart failure),
- Neurological disorders affecting respiratory muscles or any muscular dystrophies (cervical disc or bulge).
- Patient with haemodynamic instability.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Threshold Inspiratory muscle trainerAlso: posture correction exercisesthreshold inspiratory muscle trainer device Each subject will breathe through a separate mouthpiece through attach the mouthpiece firmly While putting a nose clip and inhale deeply through the mouthpiece to generate an inspiratory pressure greater than the indicated presetting threshold pressure to compress the spring and open the valve. Using High - intensity interval training technique | Device | exoerimental Group |
| posture correction exercisesconventional exercise consists of * Cervical isometric exercises will be performed in the sitting position by resisting at the forehead (cervical flexion, extension, rotation and side bending) for 10 seconds with 15 seconds breaks between holds with 10-15 repetitions in a progressive manner 3time/week for 12 weeks. * Postural correction exercise consists of gently rolling of pelvis forward to an upright neutral sitting position, followed by scapular correction and occipital lift. Also, for the sub-occipital muscles stretching * stretching exercises for scalene and levator muscles | Other | Control Group, exoerimental Group |
Primary outcome
improve ventilatory functions
Time frame: 3 months
measure ventilatory functions in percentage from predictied using spirometery (Digital-CONTEC-SP10-Spirometer-Lung Breathing-Diagnostic (Made in China), to measure ventilatory function test parameters.changes * Forced expiratory volume in the first second (FEV1) * Forced vital capacity (FVC). * FEV1/FVC ratio * Peak expiratory flow rate (PEFR).
Diaphragmatic execursion
Time frame: 3 months
Diaphragmatic sonography model (LOG IQ E10S) for measuring diaphragmatic excursion changes.in centimeter
chest expansion tests
Time frame: 3 months
Using tape Measurement tool: To measure chest expansion changes in centimetres at the suprasternal notch, at the nipple and xiphoid levels.
2 secondary outcomes
craniocervical angle
Time frame: 3 months
Body mass index
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Threshold Inspiratory muscle trainer and posture correction exercises in people with FHD, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improve ventilatory functions (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024; AzTrials last refreshed its copy on 29 Oct 2026.