NCT06883721

Brief Summary

This study aims to investigate and compare the effects of 8-week Pilates exercises and cervical stabilization exercises on pain, posture, range of motion, quality of life, and body composition in individuals with forward head posture (FHP). FHP is a common postural disorder characterized by the anterior displacement of the head relative to the cervical spine. This condition can lead to neck pain, muscle tension, and limited movement. The study will include participants aged 18-50 years with FHP. Participants will be randomly assigned to one of two groups: the Pilates group or the cervical stabilization exercise group. The Pilates group will participate in Pilates exercises twice a week for 8 weeks under the supervision of a physiotherapist. The cervical stabilization exercise group will perform cervical stabilization exercises at home for the same duration. The primary objective of this study is to compare the effects of Pilates and cervical stabilization exercises on FHP. Participants' posture, neck pain, range of motion, quality of life, and body composition will be measured before and after the 8-week intervention. These measurements will be used to evaluate and compare the effectiveness of the two exercise methods on FHP. This study seeks to investigate the effectiveness of Pilates in the treatment of FHP and contribute to the scientific literature in this field. The findings may help determine the most appropriate exercise method for individuals with FHP.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 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

January 25, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2023

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 5, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 19, 2025

Completed
Last Updated

March 19, 2025

Status Verified

March 1, 2025

Enrollment Period

4 months

First QC Date

March 5, 2025

Last Update Submit

March 16, 2025

Conditions

Keywords

Forward head posturePilatesCraniovertebral angleCervical stabilizationRandomized controlled trialNeck painPostureRehabilitation

Outcome Measures

Primary Outcomes (2)

  • Craniovertebral Angle (CVA)

    The craniovertebral angle (CVA), a key metric and a widely used measure for assessing forward head posture (FHP), will be evaluated using standardized digital photogrammetry. Lateral photographs will be captured using a Fujifilm XT-3 mirrorless camera equipped with a 35mm lens. The CVA will be calculated as the angle between a line connecting the tragus and C7 markers and a horizontal reference line parallel to the floor. Higher CVA values will indicate a less severe forward head posture, reflecting better postural alignment.

    Baseline (week 0) and after the 8-week intervention (week 8).

  • Neck Pain Intensity

    Neck pain intensity will be assessed using the Visual Analog Scale (VAS), a 10 cm line ranging from 0 (no pain) to 10 (unbearable/most severe pain). Participants will be instructed to rate their neck-specific discomfort on this scale. Lower scores will indicate less pain, while higher scores will indicate more severe pain.

    Baseline (week 0) and after the 8-week intervention (week 8).

Secondary Outcomes (8)

  • Posture

    Baseline (week 0) and after the 8-week intervention (week 8)

  • Cervical Range of Motion (ROM)

    Baseline (week 0) and after the 8-week intervention (week 8)

  • SF-36 Quality of Life Questionnaire

    Baseline (week 0) and after the 8-week intervention (week 8)

  • Body Mass Index (BMI)

    Baseline (week 0) and after the 8-week intervention (week 8)

  • Waist-to-hip ratio

    Baseline (week 0) and after the 8-week intervention (week 8)

  • +3 more secondary outcomes

Study Arms (2)

Pilates Exercise Group

EXPERIMENTAL

Participants in this group performed Pilates exercises twice a week for 8 weeks. The exercises included mat and equipment-based exercises, focusing on core stabilization, breathing control, and postural alignment. Exercise difficulty was progressively increased throughout the intervention period.

Behavioral: Pilates

Cervical Stabilization Exercise Group

ACTIVE COMPARATOR

Participants in this group performed cervical stabilization exercises at home twice daily for 8 weeks.

Behavioral: Cervical stabilization exercise

Interventions

PilatesBEHAVIORAL

Participants in this group performed Pilates exercises twice a week for 8 weeks. The exercises included mat and equipment-based exercises, focusing on core stabilization, breathing control, and postural alignment. Exercise difficulty was progressively increased throughout the intervention period.

Pilates Exercise Group

Participants in this group performed cervical stabilization exercises at home twice daily for 8 weeks. The exercises included chin tucks, cervical extensions, shoulder elevations, and scapular retractions.

Cervical Stabilization Exercise Group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adults aged 18-50 years.
  • Craniovertebral angle (CVA) \< 54°
  • Sedentary lifestyle

You may not qualify if:

  • History of spinal surgery (cervical/thoracic/lumbar) or neurological disorders.
  • Acute or severe cervical trauma (e.g., fractures, whiplash injuries).
  • Spinal deformities (e.g., scoliosis, kyphosis).
  • Recent physiotherapy/manual therapy (within the past 6 months).
  • Regular use of analgesics, muscle relaxants, or steroids.
  • Active participation in regular exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physiolab Physiotherapy Center

Antalya, Alanya, 07460, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neck Pain

Interventions

Exercise Movement Techniques

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
A blinded assessor performed all outcome measurements (NYPRS, VAS, goniometry, SF-36, anthropometric measurements).
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned to either an experimental group (Pilates exercise group, n=18) or a control group (cervical stabilization exercise group, n=18) for an 8-week intervention period.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist Physiotherapist, PhD Student

Study Record Dates

First Submitted

March 5, 2025

First Posted

March 19, 2025

Study Start

January 25, 2023

Primary Completion

May 18, 2023

Study Completion

May 18, 2023

Last Updated

March 19, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

All anonymized individual participant data (IPD) collected in this study, including demographic details, clinical measurements (CVA, pain scores, cervical ROM), SF-36 quality-of-life outcomes, and body composition data, will be shared upon reasonable request. Data will exclude raw imaging files, identifiable personal information, and non-anonymized records. Access requires submission of a scientifically valid proposal, a signed data access agreement, and compliance with ethical guidelines. Shared data will be deposited in a secure, open-access repository (e.g., Zenodo) with a DOI assigned for long-term availability. Data will remain accessible for at least 5 years post-publication. Requests will be reviewed by an independent committee to ensure alignment with research ethics and participant privacy protections (GDPR/Helsinki Declaration compliant).

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
IPD and supporting information will be available starting March 5, 2025 and will remain accessible for 5 years.
Access Criteria
Anonymized individual participant data (IPD) and supporting documents (study protocol, statistical analysis plan, informed consent form) will be provided upon request to researchers affiliated with academic institutions who have collaborated with the institution where the study was conducted and have signed a data use agreement. To access the data, researchers must submit their research proposals and request forms directly to yusufyasasin@gmail.com. The data will be stored on the secure server of the institution where the study was conducted. Access requests will be approved by the ethics committee of the institution where the study was conducted.

Locations