An observational study in Rehabilitation, sponsored by Pomeranian Medical University Szczecin. Not yet recruiting. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-01-09.
Sponsored by Pomeranian Medical University Szczecin · Observational
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).
Cardiovascular diseases, particularly advanced coronary artery disease requiring interventions like Coronary Artery Bypass Grafting (CABG), are major global health concerns. Comprehensive cardiac rehabilitation (CR) is a crucial element in patient recovery, yet its effectiveness varies significantly. The main objective of this project is the comprehensive evaluation of the actual effectiveness of standard CR and the identification of multi-faceted factors-biological, functional, and psychosocial-that influence its outcomes and long-term prognosis.
Methodology and Study Design The project plans to recruit 150 male and female patients, aged 50-80 years, who are hospitalized in the cardiac rehabilitation ward, primarily following CABG surgery.
Assessments will be conducted at three key time points to monitor the dynamic nature of changes:
Baseline (T0): At the beginning of cardiac rehabilitation.
Post-Rehab (T1): At the conclusion of the standard rehabilitation program.
Follow-up (T2): Approximately 3-6 months after the patient's discharge.
Detailed Research Domains
The study will focus on several key domains to comprehensively assess the mechanisms underlying recovery:
A. Functional and Physical Assessment
Exercise Tolerance: Measured using the 6-Minute Walk Test (6MWT).
Physical Fitness and Strength: Assessed via Handgrip Dynamometry, the Barthel Scale for daily living activities, and the Tinetti Scale for balance and gait.
Body Composition: Detailed analysis using Bioelectrical Impedance Analysis (BIA) to track changes in muscle mass and fat tissue.
Diaphragm Function: Evaluation of diaphragm muscle thickness and mobility using Ultrasound (USG) to monitor respiratory improvement.
Postural Stability: Assessment of pressure distribution using a tensiometric mat (posturography).
B. Psychological and Neurocognitive Assessment
Mental Status: Evaluated using validated scales, including the WHO-5 Well-Being Index and the HADS Scale for anxiety and depression.
Cognitive Function: Screening for potential post-surgery cognitive impairment (memory, concentration) using the MoCA and MMSE scales.
C. Sleep Disorders and Biological/Hormonal Factors
Obstructive Sleep Apnea (OSA): Objective assessment of the frequency and severity of OSA using a portable sleep monitor.
Oral Health \& OSA Risk: Detailed dental and craniofacial examinations to assess OSA risk factors related to the oral cavity status.
Hormonal and Biochemical Markers: Analysis of sex hormones (Testosterone, Estradiol) and their correlation with overall condition and rehabilitation response.
Myokines and Metabolic Signaling: Measurement of myokines (Irisin, Myostatin) and related proteins to understand mechanisms of exercise adaptation.
Standard Laboratory Tests: Including standard markers like lipid profile, glucose, HbA1c, CRP, homocysteine, and Vitamin D3.
Significance and Expected Outcomes The project aims to establish a patient profile that clearly identifies who benefits most from CR and who is at risk of poor outcomes. This identification of predictive factors will enable the early introduction of personalized interventions, such as targeted physical therapy, psychological support, or specialized diagnostics for sleep disorders. The ultimate goal is to optimize CR programs, maximizing gains in physical capacity, quality of life, and the long-term cardiac prognosis for patients.
3,872 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.
This study's planned enrollment of 150 is close to the median of 150 across 997 observational studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →Pomeranian Medical University Szczecin is the lead sponsor of 69 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Male patients aged 50-80 years who have undergone coronary artery bypass graft (CABG) surgery and are currently hospitalized for cardiac rehabilitation. The study population includes individuals from a single clinical center in Poland.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Change in Physical Capacity (6MWT)
Distance walked in 6 minutes measured in meters using the 6-Minute Walk Test (6MWT). The test reflects objective functional improvement in physical capacity.
Time frame: Baseline (start of hospitalization/T0) and Post-Rehab (end of cardiac rehabilitation/T1, approximately 3-4 weeks later)
Change in Psychological Status (HADS)
Assessment using the Hospital Anxiety and Depression Scale (HADS). The scale consists of 14 items (7 for anxiety and 7 for depression). Each item is scored from 0 to 3. Total score for each subscale ranges from 0 to 21. Higher scores indicate greater severity of anxiety or depression.
Time frame: Baseline, Post-Rehab (approx. 3-4 weeks later), and Follow-up (3-6 months after discharge
Diaphragm Thickness
Assessment of diaphragm muscle thickness measured in millimeters (mm) using Ultrasound (USG) at the end of expiration.
Time frame: Baseline and Post-Rehab (approx. 3-4 weeks later).
Change in Diaphragm Mobility
Assessment of diaphragm excursion measured in centimeters (cm) during maximum inspiration and expiration using Ultrasound (USG).
Time frame: Baseline and Post-Rehab (approx. 3-4 weeks later).
Change in Montreal Cognitive Assessment (MoCA) Score
Cognitive screening using the MoCA scale. Total score ranges from 0 to 30. Higher scores indicate better cognitive function with a score of 26 or above generally considered normal.
Time frame: Baseline, Post-Rehab (approx. 3-4 weeks later), and Follow-up (3-6 months after discharge).
Change in Mini-Mental State Examination (MMSE) Score
Cognitive screening using the MMSE scale. Total score ranges from 0 to 30. Higher scores indicate better cognitive function where a score of 24-30 is typically considered normal.
Time frame: Baseline, Post-Rehab (approx. 3-4 weeks later), and Follow-up (3-6 months after discharge).
Change in Apnea-Hypopnea Index (AHI)
Frequency and severity of Obstructive Sleep Apnea (OSA) events assessed using a portable sleep monitor. The outcome is the number of apneas and hypopneas per hour of sleep (AHI index)
Time frame: Baseline and Post-Rehab (approx. 3-4 weeks later).
Change in Sex Hormones Concentration
Serum concentration of Total Testosterone (measured in ng/dL) and Estradiol (measured in pg/mL).
Time frame: Baseline (fasting) and Post-Rehab (fasting, approx. 3-4 weeks later)
Change in Myokines and Metabolic Markers Concentration
Serum concentration of Irisin and Myostatin (measured in ng/mL) and other related markers (e.g., PGC-1α, FNDC5, mTOR)
Time frame: Baseline (fasting) and Post-Rehab (fasting, approx. 3-4 weeks later).
No study locations are listed for this record.
Start is estimated for Jan 2026; primary completion for Jun 2029, 41 months later.
Of 504 non-industry observational studies under Cognitive Dysfunction, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 118. This study's planned 41 months is below that.
Counting every sponsor, half of 543 studies reached it within 47 months; a quarter within 21 and three quarters within 118.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Pomeranian Medical University Szczecin