The effect of adding an individualized staged corrective-exercise program to a foundational active intervention on the postural profile of adults meeting prespecified postural criteria for upper crossed syndrome: a randomized controlled trial

To compare the added effect of 12-week individualized corrective exercise versus an active intervention on posture; EMG, range of motion, and balance are secondary, and EEG is exploratory.

Two-arm parallel trial, 36 participants, 1:1 allocation, blocks of four and six, stratified by sex; assessors, signal processors, and statistician blinded.

Assessments occur at Arak University, EEG at Valiasr Hospital, and training at Diaphragm Clinic. Assessments are at baseline, week 12, and four-week follow-up; EMG and EEG have no follow-up.

Inclusion: women and men aged 18–40 years, BMI 18.5–24.9, residing in Arak, with head ≥44°, shoulder ≥49°, and kyphosis ≥42°; consent and ability to attend. Exclusion: relevant surgery/fracture; neurological, psychiatric, musculoskeletal, or cardiopulmonary disease; CNS medication; acute pain; pregnancy; trunk rotation >5°; balance disorder; or recent regular exercise.

Intervention: 36 sessions of 60–80 minutes; active foundational intervention plus individualized staged exercise. Comparator: 36 sessions of 20–30 minutes including cycling, stretching, mobilization, and education.

Primary outcome: head, shoulder, and kyphosis angle profile at week 12. EMG, range of motion, and balance are secondary; EEG is exploratory.

Due to the armed conflict and its consequences, including disrupted access to the study sites, restrictions on the operation of collaborating centers, and the absence of safe conditions for participant recruitment and assessment, the study could not begin as originally scheduled. Consequently, study implementation was postponed, and the study timeline and protocol details were reviewed and updated before the enrollment and randomization of the first participant. At the time of this update, no participant had been randomized and no outcome data had been collected or analyzed.

After completion of baseline assessment, an independent statistician will generate the allocation sequence using randomly permuted blocks of four and six, with a 1:1 allocation ratio and stratification by sex. Block sizes and the allocation sequence will remain concealed from personnel involved in recruitment and assessment. Allocation will be concealed using sequentially numbered, opaque, tamper-evident, sealed envelopes. The next envelope will be opened only after eligibility has been confirmed, baseline assessment completed, and the participant irreversibly enrolled, by a person who has no access to the allocation sequence.

Because of the nature of the intervention, participants and the intervention provider cannot be blinded. Outcome assessors, EMG and EEG processors, and the statistician will remain blinded to group allocation until completion of the primary analysis. Images, Formetric outputs, and signal files will be coded without group or time-point information and presented in random order. The code key will be held by an independent person, and any inadvertent unblinding will be documented.

The approved protocol, amendments, statistical analysis plan, data dictionary, analytic code, and the deidentified individual-level minimal dataset will be deposited in a stable public repository when the trial results are published. Coded assessment photographs and videos and raw biosignals that may carry a residual risk of re-identification will not be made publicly available and may be requested only through controlled-access procedures.

Publicly shareable files will be deposited in a stable repository when the primary trial results are published and will remain available indefinitely or according to repository policy. Requests for controlled access to sensitive data may be considered after publication of the trial results.

The deidentified minimal dataset, data dictionary, and analytic code will be available to researchers through a public repository. Access to sensitive data will require a specific and justified scientific purpose, approval by the relevant institutional body or ethics committee, and execution of a data-use agreement. Access decisions will not be controlled by a single author.

Performing statistical analyses within the scope of published articles related to the present research is permissible. However, the misuse of data to extract new findings is strictly prohibited.

The public repository link will be added to the trial record and results article when available. Requests for controlled access to sensitive data should be submitted to the institutional email address m.khorami@spr.ui.ac.ir and should specify the research purpose, requested data, analysis plan, institutional or ethics approval, and data-protection plan. Requests will be reviewed by the relevant institutional body and research team; approved access will be provided under a data-use agreement.

The applicant must provide a compelling and specific justification for requesting the data. Upon receipt of the request, they will be notified that their application is under review. Following approval by the research team, the data will be made available to the applicant within one month from the start of the request review.