- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07924995
Home-Based Corrective Exercise With Remote Reinforcement for Upper Crossed Syndrome
Effects of a Home-Based Corrective Exercise Program With Active Remote Reinforcement on Craniovertebral Angle, Rounded Shoulder Posture, Thoracic Kyphosis, Pain, Cervical and Shoulder Disability, and Pulmonary Function i Adults With Upper Crossed Syndrome: A Two-Arm Parallel Randomized Controlled Trial
Upper Crossed Syndrome (UCS) is a musculoskeletal condition defined by simultaneous forward head posture (craniovertebral angle, CVA < 52°), rounded shoulders (RSP > 52°), and thoracic hyperkyphosis (> 42°). It is highly prevalent in sedentary workers and musicians and is associated with neck pain, shoulder pain, and reduced pulmonary function. This two-arm parallel randomized controlled trial will compare two home-based corrective exercise programs over 12 weeks in adults with confirmed UCS. Both groups (Experimental, EG; Control, CG) perform the same 20-minute program three times per week: diaphragmatic breathing re-education and targeted muscle strengthening and stretching. The EG additionally uses a volumetric incentive spirometer (Coach2, 4000 mL) as respiratory biofeedback and receives active remote reinforcement (biweekly video calls + asynchronous educational material from a physiotherapist); the CG performs the same exercises without the spirometer and receives only minimal adherence monitoring. Outcomes are assessed at baseline (week 0) and at weeks 4, 8, and 12. Primary outcome: craniovertebral angle (CVA) measured by lateral photogrammetry. Secondary outcomes: rounded shoulder angle (RSP), thoracic kyphosis (bubble inclinometer and smartphone inclinometer), pain (Visual Analogue Scale), cervical disability (Neck Disability Index), shoulder pain and disability (SPADI), exercise adherence, and pulmonary function (spirometry: FVC, FEV₁/FVC, MVV) at weeks 0 and 12. Recruitment will take place at the Associació Amics de la Música de Meliana, Fisioterapia A Punto, and Universidad Cardenal Herrera CEU (Valencia, Spain). A total of 96 participants (48 per arm) will be enrolled over a 2-year recruitment window.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Jorge M Montero-Cámara, PhD
- Telefonnummer: +34611661505
- E-post: jorge.camara@uchceu.es
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
-
• Confirmed UCS diagnosis, defined by the simultaneous presence of: (a) craniovertebral angle (CVA) < 52°; (b) rounded shoulder posture angle (RSP) > 52°; and (c) thoracic kyphosis angle > 42°.
- Age between 18 and 65 years.
- Available and willing to perform the home exercise program and to attend all four face-to-face assessment sessions (weeks 0, 4, 8, and 12).
- Access to a camera-equipped device (smartphone or tablet) for remote monitoring and reinforcement.
- Ability to understand the study procedures and to sign informed consent.
Exclusion Criteria:
-
Severe cervical or thoracic pathology: vertebral fracture, neoplasm, infection, or active systemic inflammatory disease.
- Spinal surgery within the preceding 12 months.
- Respiratory pathology contraindicating use of a volumetric incentive spirometer: recent pneumothorax (< 6 weeks), COPD GOLD grade III-IV, or unstable bronchial asthma.
- Active physiotherapy treatment specifically targeting UCS within the preceding 3 months.
- Pregnancy or breastfeeding.
- Cognitive impairment or language barrier preventing comprehension of the exercise program.
- Simultaneous participation in another clinical trial.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Experimental Group (EC)
Home-based corrective exercise program (3 sessions/week × 12 weeks, 20 min/session) combining: (1) diaphragmatic breathing re-education with a volumetric incentive spirometer (Coach2, 4000 mL, Smiths Medical) as biofeedback - 4 progressive levels, 10 repetitions; (2) muscle strengthening and stretching targeting the deep cervical flexors, lower and middle trapezius, rhomboids, and pectoral/suboccipital muscles. The EG additionally receives active remote reinforcement: a biweekly video call with a physiotherapist and asynchronous educational material (written guides and video tutorials) delivered via a messaging platform. |
Home-based corrective exercise program (3 sessions/week × 12 weeks, 20 min/session) combining: (1) diaphragmatic breathing re-education with a volumetric incentive spirometer (Coach2, 4000 mL, Smiths Medical) as biofeedback - 4 progressive levels, 10 repetitions; (2) muscle strengthening and stretching targeting the deep cervical flexors, lower and middle trapezius, rhomboids, and pectoral/suboccipital muscles. The EG additionally receives active remote reinforcement: a biweekly video call with a physiotherapist and asynchronous educational material (written guides and video tutorials) delivered via a messaging platform. |
|
Aktiv komparator: Control Group (CG)
Identical home-based corrective exercise program (3 sessions/week × 12 weeks, 20 min/session) with the same muscle strengthening and stretching exercises. The CG does not use an incentive spirometer (diaphragmatic breathing performed without device) and does not receive active remote reinforcement; adherence monitoring is minimal (standardized paper diary). |
Identical home-based corrective exercise program (3 sessions/week × 12 weeks, 20 min/session) with the same muscle strengthening and stretching exercises. The CG does not use an incentive spirometer (diaphragmatic breathing performed without device) and does not receive active remote reinforcement; adherence monitoring is minimal (standardized paper diary). |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Craniovertebral Angle (CVA)
Tidsram: Baseline (Week 0), Week 4, Week 8, Week 12
|
Angle formed between the horizontal line at the C7 spinous process and the line connecting C7 to the ipsilateral ear tragus, measured by lateral photogrammetry using standardized adhesive markers and Kinovea software. A lower CVA indicates greater forward head posture (normal > 52°). |
Baseline (Week 0), Week 4, Week 8, Week 12
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Rounded Shoulder Posture Angle (RSP)
Tidsram: Baseline (Week 0), Week 4, Week 8, Week 12
|
Angle between the line connecting the C7 spinous process to the right acromion and the horizontal, measured by lateral photogrammetry (Kinovea). Values > 52° indicate rounded shoulder posture. |
Baseline (Week 0), Week 4, Week 8, Week 12
|
|
Thoracic Kyphosis Angle - Bubble Inclinometer
Tidsram: Baseline (Week 0), Week 4, Week 8, Week 12
|
Single-inclinometer sequential method: the instrument (Baseline, Fabrication Enterprises Inc., White Plains, NY) is zeroed at T1 and the angle is read at T12. Three measurements per time point; mean used for analysis. |
Baseline (Week 0), Week 4, Week 8, Week 12
|
|
Thoracic Kyphosis Angle - Smartphone Inclinometer
Tidsram: Baseline (Week 0), Week 4, Week 8, Week 12
|
Same T1-T12 sequential method using the Clinometer app (Plaincode) on iPhone 17. The upper corner of the narrow side of the phone is placed at T1 (zeroed to 0°), then moved to T12 (angle read). Three measurements per time point; mean used for analysis. |
Baseline (Week 0), Week 4, Week 8, Week 12
|
|
Pain Intensity - Visual Analogue Scale (VAS)
Tidsram: Baseline (Week 0), Week 4, Week 8, Week 12
|
100-mm horizontal VAS (0 = no pain; 100 = worst imaginable pain) for neck and interscapular pain during the past week. Minimum clinically important difference (MCID): 15 mm. |
Baseline (Week 0), Week 4, Week 8, Week 12
|
|
Cervical Disability - Neck Disability Index (NDI)
Tidsram: Baseline (Week 0), Week 4, Week 8, Week 12
|
10-item self-reported questionnaire assessing the impact of neck pain on daily activities; total score 0-50. Spanish validated version used. MCID: 5 points (10%). Interpretation: 0-8% no disability; 10-28% mild; 30-48% moderate; 50-64% severe; ≥ 64% complete disability. |
Baseline (Week 0), Week 4, Week 8, Week 12
|
|
Shoulder Pain and Disability - SPADI
Tidsram: Baseline (Week 0), Week 4, Week 8, Week 12
|
13-item self-reported questionnaire with two subscales (Pain: 5 items; Disability: 8 items), each item scored 0-10. Total score 0-100 (higher = worse). MCID: 13-18 points. Spanish validated version used. |
Baseline (Week 0), Week 4, Week 8, Week 12
|
|
Exercise Adherence
Tidsram: Weeks 1-12 (cumulative at each assessment point)
|
Percentage of prescribed sessions completed out of 36 planned sessions (3/week × 12 weeks), recorded in standardized session diaries. Adequate adherence defined as ≥ 70% |
Weeks 1-12 (cumulative at each assessment point)
|
|
Forced Vital Capacity (FVC, % predicted)
Tidsram: Baseline (Week 0), Week 12
|
Spirometric measurement (forced vital capacity as percentage of age-sex-height-weight predicted value). ATS acceptability and reproducibility criteria applied; 3 measurements per session, mean used. |
Baseline (Week 0), Week 12
|
|
FEV₁/FVC Ratio (% predicted)
Tidsram: Baseline (Week 0), Week 12
|
Ratio of forced expiratory volume in 1 second to forced vital capacity, expressed as percentage of predicted value. |
Baseline (Week 0), Week 12
|
|
Maximum Voluntary Ventilation (MVV, % predicted)
Tidsram: Baseline (Week 0), Week 12
|
Spirometric measure of maximum airflow over 12-15 seconds, expressed as percentage of predicted value. |
Baseline (Week 0), Week 12
|
Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Allmänna publikationer
- Karimian R, Rahnama N, Ghasemi G, Lenjannejadian S. Photogrammetric Analysis of Upper Cross Syndrome among Teachers and the Effects of National Academy of Sports Medicine Exercises with Ergonomic Intervention on the Syndrome. J Res Health Sci. 2019 Jul 3;19(3):e00450.
- Sepehri S, Sheikhhoseini R, Piri H, Sayyadi P. The effect of various therapeutic exercises on forward head posture, rounded shoulder, and hyperkyphosis among people with upper crossed syndrome: a systematic review and meta-analysis. BMC Musculoskelet Disord. 2024 Feb 1;25(1):105. doi: 10.1186/s12891-024-07224-4.
- Jeong GH, Lee BH. Effects of Telerehabilitation Combining Diaphragmatic Breathing Re-Education and Shoulder Stabilization Exercises on Neck Pain, Posture, and Function in Young Adult Men with Upper Crossed Syndrome: A Randomized Controlled Trial. J Clin Med. 2024 Mar 11;13(6):1612. doi: 10.3390/jcm13061612.
- Chaudhuri S, Chawla JK, Phadke V. Physiotherapeutic Interventions for Upper Cross Syndrome: A Systematic Review and Meta-Analysis. Cureus. 2023 Sep 18;15(9):e45471. doi: 10.7759/cureus.45471. eCollection 2023 Sep.
- Yan X, Kim T-H. The Impact of Combined Scapular Stabilization and Breathing Training on Pain and Respiratory Function in Individuals with Upper Cross Syndrome. Appl Sci. 2025;15:6147. doi: 10.3390/app15116147
- Kalantariyan M, Sadeghi M, Samadi H. Manual massage versus foam rolling within the NASM corrective framework: a trial for upper crossed syndrome rehabilitation in university students. Sci Rep. 2026 Jan 27;16(1):5471. doi: 10.1038/s41598-026-35030-6.
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CEEI26_865
- CEEI26_865 (Annan identifierare: CardenalHU)
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