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Effects of External Upper Limb Loading on Gait and Trunk Muscle Activity in Cardiac Rehabilitation Patients (ND)

2 septembre 2026 mis à jour par: Pomeranian University in Slupsk

Biomechanical, Electromyographic, and Baropodometric Assessment of Gait Parameters and Trunk-Stabilizing Muscle Activity at Baseline and Under Unilateral and Bilateral Upper Limb Loading in Patients Undergoing Cardiac Rehabilitation

This study examines how external loading applied to the upper limbs affects gait parameters and the activity of selected trunk- and pelvis-stabilizing muscles (erector spinae, gluteus medius, tensor fasciae latae, external oblique) in patients undergoing cardiac rehabilitation. Participants are medically stable adults (18-80 years) referred to cardiac rehabilitation following a cardiac event or procedure, meeting NYHA class I-II criteria, with no unstable coronary disease, uncontrolled hypertension, neurological disease, or other exclusion criteria.

Participants will walk on a treadmill at 1 km/h, 3 km/h and 5 km/h under three conditions: without load, with unilateral upper-limb loading, and with bilateral upper-limb loading. Muscle activity will be recorded using surface electromyography (sEMG), and plantar pressure/gait parameters will be recorded simultaneously using baropodometry integrated into the treadmill. The procedure is non-invasive, does not breach the skin, and does not involve any additional intervention beyond standard rehabilitation. To contextualize functional outcomes, previously collected exercise stress test results (performed independently by the treating physician before and after cardiac rehabilitation, as part of routine clinical care) will be retrieved from participants' medical records for comparison; this is a retrospective data comparison, not an additional study intervention.

No financial compensation is provided. Each participant will receive an individual report of their sEMG and gait findings with professional interpretation. Risks are minimal and limited to transient skin irritation from electrodes and mild, temporary muscle fatigue or soreness typical of moderate exercise. Participants may withdraw at any time.

Aperçu de l'étude

Statut

Actif, ne recrute pas

Les conditions

Intervention / Traitement

Description détaillée

Study Design and Rationale This is a prospective, observational biomechanical and neuromuscular study evaluating the effect of external upper-limb loading (unilateral, dominant and non-dominant side, and bilateral) on gait parameters and the activity of selected trunk- and pelvis-stabilizing muscles in patients undergoing cardiac rehabilitation. Existing literature on muscle activity during loaded walking is limited, and the extent and pattern of these changes are not yet well characterized. This study aims to address that gap and provide data relevant to rehabilitation practice, including load standardization in physiotherapy.

Participants 50-60 adults (18-80 years) referred to cardiac rehabilitation following a cardiac event or procedure (including patients several years post-event), medically stable and classified as NYHA class I-II. Recruitment uses stratified random sampling, with strata based on sex and age to ensure balanced representation. Exclusion criteria include unstable coronary artery disease, recent myocardial infarction (<4 weeks), NYHA class III-IV heart failure, uncontrolled hypertension, cardiac arrhythmias, neurological or neurodegenerative disease, acute lower-limb or spinal injury, gait pathology, poorly controlled diabetes with hypoglycemia risk, pregnancy, BMI >35 kg/m², and lack of consent.

Procedures Participants complete a health/medical history questionnaire followed by a preliminary diagnostic assessment of physical capacity. During the main protocol, participants walk on a treadmill at 1 km/h, 3 km/h and 5 km/h under three loading conditions (no load, unilateral, bilateral), while sEMG records activity of the erector spinae, gluteus medius, tensor fasciae latae, and external oblique muscles, and baropodometry (integrated into the treadmill) simultaneously records plantar pressure and gait parameters.

Additionally, exercise stress test results obtained by the participant's physician before and after cardiac rehabilitation - performed independently of this study as part of routine clinical care - are retrieved from medical records by a research team member with institutional authorization to access patient data, and compared with the sEMG/gait findings. No stress testing is performed by the research team as part of this protocol.

Ethical and Regulatory Compliance The protocol has been reviewed and approved by the relevant bioethics committee. Written informed consent is obtained from all participants prior to participation. Access to participants' medical records (stress test results) is conducted under existing institutional authorization held by a research team member.

Type d'étude

Observationnel

Inscription (Réel)

60

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Pologne
      • Słupsk, Pologne, 76-200
        • Wojewódzki Szpital Specjalistyczny w Słupsku

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon de probabilité

Population étudiée

Participants are adult patients referred to a hospital-based cardiac rehabilitation program (Wojewódzki Szpital Specjalistyczny w Słupsku) following a cardiac event or procedure, who are medically stable and undergoing supervised outpatient/inpatient cardiac rehabilitation. Assessments are conducted by the biomechanics laboratory (Pomeranian University in Słupsk).

La description

Inclusion Criteria:

  • Age ≥18 and ≤80 years
  • Referred to cardiac rehabilitation following a cardiac event or procedure
  • Medically stable, classified as NYHA class I-II
  • Able and willing to provide informed consent
  • Willing and able to complete the study procedures
  • Able to safely perform treadmill walking and exercise testing
  • No cardiological or pulmonological contraindications to exercise
  • No limb deformities or gait pathology identified on clinical interview

Exclusion Criteria:

  • Unstable coronary artery disease, recent myocardial infarction (<4 weeks), or recent revascularization (<4 weeks)
  • Heart failure NYHA class III-IV
  • Uncontrolled hypertension
  • Cardiac arrhythmias
  • Neurological or neurodegenerative disease
  • Acute lower-limb or spinal injury, musculoskeletal deformity, or significant pain affecting gait
  • Diabetes mellitus with hypoglycemia tendency
  • Pregnancy
  • BMI >35 kg/m²
  • Lack of informed consent

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
Cardiac Rehabilitation Patients
Adult patients (N=60) (18-80 years) referred to cardiac rehabilitation following a cardiac event or procedure, medically stable and classified as NYHA class I-II. Each participant is assessed at two time points: at the start of cardiac rehabilitation (Day 1) and approximately 20 rehab-days later, following completion of the rehabilitation program. At each session, participants walk on a treadmill at 3 km/h and 5 km/h under three loading conditions (no load, unilateral upper-limb loading, bilateral upper-limb loading), while gait parameters and trunk/pelvic muscle activity are recorded.
Autre: External Upper Limb Loading During Treadmill Walking
Participants walk on a treadmill at controlled speeds (3 km/h and 5 km/h) under three conditions: without external load, with unilateral upper-limb loading (dominant and non-dominant side), and with bilateral upper-limb loading. Gait parameters and lower-limb/trunk muscle activity are recorded simultaneously via surface electromyography (sEMG) and baropodometry integrated into the treadmill system. This is a non-invasive assessment procedure, not a therapeutic intervention.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Mean sEMG-Derived Neuromuscular Asymmetry Index
Délai: Day 1 of cardiac rehabilitation (baseline)

Asymmetry index from normalized RMS sEMG amplitude of erector spinae, gluteus medius, tensor fasciae latae, and external oblique, dominant vs. non-dominant side during unloaded treadmill walking. Expressed as a percentage; 0% indicates perfect symmetry, higher values greater asymmetry.

Unit of Measure: percentage · Measure Type: Mean
Day 1 of cardiac rehabilitation (baseline)
Mean Plantar Pressure Distribution Asymmetry Index
Délai: Day 1 of cardiac rehabilitation (baseline)

Asymmetry index from baropodometric plantar pressure distribution, dominant vs. non-dominant lower limb during unloaded treadmill walking. Expressed as a percentage; 0% indicates perfect symmetry, higher values greater asymmetry.

Unit of Measure: percentage · Measure Type: Mean
Day 1 of cardiac rehabilitation (baseline)
Mean Spatiotemporal Gait Asymmetry Index
Délai: Day 1 of cardiac rehabilitation (baseline)

Asymmetry index from spatiotemporal gait parameters (step length, stance and swing phase duration), dominant vs. non-dominant lower limb during unloaded treadmill walking. Expressed as a percentage; 0% indicates perfect symmetry, higher values greater asymmetry.

Unit of Measure: percentage · Measure Type: Mean
Day 1 of cardiac rehabilitation (baseline)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Mean Change from Baseline in sEMG-Derived Neuromuscular Asymmetry Index After Rehabilitation
Délai: After completion of 20 rehabilitation sessions (approximately 30 days)

Mean change from baseline (Day 1) to the end of the rehabilitation program (after 20 sessions, approximately 30 days) in the sEMG-derived neuromuscular asymmetry index (normalized RMS sEMG amplitude of erector spinae, gluteus medius, tensor fasciae latae, and external oblique), during unloaded treadmill walking at 1, 3, and 5 km/h. Expressed in percentage points; a negative value indicates reduced asymmetry.

Unit of Measure: percentage points · Measure Type: Mean
After completion of 20 rehabilitation sessions (approximately 30 days)
Mean Change from Baseline in Plantar Pressure Distribution Asymmetry Index After Rehabilitation
Délai: After completion of 20 rehabilitation sessions (approximately 30 days)

Mean change from baseline (Day 1) to the end of the rehabilitation program (after 20 sessions, approximately 30 days) in the baropodometric plantar pressure distribution asymmetry index, during unloaded treadmill walking at 1, 3, and 5 km/h. Expressed in percentage points; a negative value indicates reduced asymmetry.

Unit of Measure: percentage points · Measure Type: Mean
After completion of 20 rehabilitation sessions (approximately 30 days)
Mean Change from Baseline in Spatiotemporal Gait Asymmetry Index After Rehabilitation
Délai: After completion of 20 rehabilitation sessions (approximately 30 days)

Mean change from baseline (Day 1) to the end of the rehabilitation program (after 20 sessions, approximately 30 days) in the spatiotemporal gait asymmetry index (step length, stance and swing phase duration), during unloaded treadmill walking at 1, 3, and 5 km/h. Expressed in percentage points; a negative value indicates reduced asymmetry.

Unit of Measure: percentage points · Measure Type: Mean
After completion of 20 rehabilitation sessions (approximately 30 days)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Pomeranian University in Slupsk

Les enquêteurs

  • Chercheur principal: Wojciech Nawos-Wysocki, MSc PT, Pomeranian University in Słupsk
  • Directeur d'études: Agnieszka Grochulska, PhD, MSc PT, Pomeranian University in Słupsk

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

15 mai 2026

Achèvement primaire (Estimé)

31 août 2026

Achèvement de l'étude (Estimé)

31 août 2026

Dates d'inscription aux études

Première soumission

12 août 2026

Première soumission répondant aux critères de contrôle qualité

2 septembre 2026

Première publication (Réel)

3 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

3 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

2 septembre 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • K01

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

De-identified individual participant data supporting the specific results reported in each peer-reviewed publication arising from this study will be made available, typically as supplementary material accompanying the relevant article. Data are shared on a per-publication basis rather than as a complete raw dataset

Délai de partage IPD

Data underlying each publication will be made available at the time of publication of that article, as supplementary material.

Critères d'accès au partage IPD

De-identified data supporting published results will be provided as supplementary files with each publication. Data beyond what is published may be requested from the corresponding author for legitimate research purposes and will be reviewed on a case-by-case basis.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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