NCT06571578

Brief 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 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?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 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

May 3, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 26, 2024

Completed
Last Updated

August 26, 2024

Status Verified

August 1, 2024

Enrollment Period

3 months

First QC Date

August 13, 2024

Last Update Submit

August 23, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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).

    3 months

  • Diaphragmatic execursion

    Diaphragmatic sonography model (LOG IQ E10S) for measuring diaphragmatic excursion changes.in centimeter

    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.

    3 months

Secondary Outcomes (2)

  • craniocervical angle

    3 months

  • Body mass index

    3 months

Study Arms (2)

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).

Device: Threshold Inspiratory muscle trainerOther: posture correction exercises

Control Group

OTHER

control group Thirty subjects will receive a conventional exercise program for FHP for 12 weeks (3 sessions/ week).

Other: posture correction exercises

Interventions

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

Also known as: posture correction exercises
exoerimental Group

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

Control Groupexoerimental Group

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale subjects from 18 to 25 years old with FHP
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university

Cairo, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomised control trial (RCT)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assisstant lecture

Study Record Dates

First Submitted

August 13, 2024

First Posted

August 26, 2024

Study Start

May 3, 2023

Primary Completion

August 1, 2023

Study Completion

February 4, 2024

Last Updated

August 26, 2024

Record last verified: 2024-08

Locations