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NOT YET RECRUITING
NCT07328789

Factors Influencing Cardiac Rehabilitation Success

Sponsor: Pomeranian Medical University Szczecin

View on ClinicalTrials.gov

Summary

Cardiovascular diseases, especially after life-saving surgeries, require comprehensive cardiac rehabilitation (CR). We know that the effectiveness of CR varies among patients. The main goal of this study is to understand which factors-psychological, physical, cognitive, biochemical, and hormonal-influence the success and long-term durability of the recovery process. These findings will help us create more effective and personalized treatment programs. Who is Being Studied and What is Being Assessed? Study Group: 150 patients of both sexes, aged 50-80 years, hospitalized in the cardiac rehabilitation ward, primarily after Coronary Artery Bypass Grafting (CABG). Study Period: Patients will be assessed at the start of their hospital stay, at the end of rehabilitation, and again 3-6 months after discharge. Key Assessment Areas (Modulating Factors) Physical Status and Fitness: Exercise tolerance (6-Minute Walk Test). Muscle strength (handgrip), balance, and gait. Body composition (analysis of muscle mass and fat tissue). Respiratory function and diaphragm mobility (ultrasound). Psychological and Cognitive Factors: Assessment of anxiety, depression, and general mental well-being. Evaluation of cognitive functions (memory, concentration) following cardiac surgery. Sleep Problems (OSA): Assessment of the risk and severity of Obstructive Sleep Apnea (OSA), which is common in cardiac patients. Analysis of OSA risk factors related to oral health (dentition, microbiome) and craniofacial structure. Biological Markers: Hormonal tests (e.g., testosterone, estradiol) and their correlation with psycho-physical condition and the rehabilitation process. Analysis of metabolic and muscle-related biomarkers (e.g., myokines: irisin, myostatin).

Official title: Assessment of the Effectiveness of Comprehensive Cardiac Rehabilitation and Identification of Factors Modulating Its Results

Key Details

Gender

All

Age Range

50 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

150

Start Date

2026-01-03

Completion Date

2029-07-01

Last Updated

2026-01-09

Healthy Volunteers

No

Conditions

Interventions

OTHER

Rehabilitation effective

This study is an observational, non-pharmacological, multi-domain assessment of patients undergoing standard comprehensive cardiac rehabilitation (CR) following CABG surgery. The intervention involves a detailed, longitudinal, three-stage evaluation (Baseline, Post-Rehab, 3-6 Month Follow-up) of the factors influencing CR outcomes. The CR itself is a standard hospital-based program, but the research intervention is distinguished by its holistic focus on measuring and correlating: Objective Functional Data: Exercise capacity (6MWT), muscle strength, diaphragm function (USG), and postural stability. Multifactorial Co-morbidities: Screening for Obstructive Sleep Apnea (OSA) (NOX-T3), Cognitive Dysfunction (MoCA/MMSE), and the role of oral health in OSA risk. Biological \& Hormonal Profile: Measuring Sex Hormones (Testosterone, Estradiol) and Myokines (Irisin, Myostatin) to understand personalized metabolic and adaptive responses to the rehabilitation program. The intervention aims to