Factors Influencing Cardiac Rehabilitation Success
ConditionRehabilitation
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-80
SponsorPomeranian Medical University Szczecin
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male patients aged 50-80 years
Hospitalization in the Cardiac Rehabilitation Ward
Undergone coronary artery bypass graft (CABG) surgery within the last 30 days
Written, informed consent to participate in the study
Disqualifiers
Type II diabetes treated with insulin
Neuro-surgical operation in the last 6 months
Aneurysms of the cerebral arteries and aorta
Recurrent ischemic stroke (Cerebral Vascular Accident)
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Rehabilitation effective
Other interventionThis 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
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
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 discharge2
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).3
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).4
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).Other outcomes
1
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).2
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)3
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).Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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