Factors Influencing Cardiac Rehabilitation Success

NCT07328789 | Not Yet Recruiting

• 1 other identifier: KB-006/65/2025
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Rehabilitation

Keywords

Cardiac Rehabilitation; Sex Hormones; Cognitive Dysfunction

Outcome Measures

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.

  Baseline (start of hospitalization/T0) and Post-Rehab (end of cardiac rehabilitation/T1, approximately 3-4 weeks later)

Secondary Outcomes (5)

• Change in Psychological Status (HADS)

  Baseline, Post-Rehab (approx. 3-4 weeks later), and Follow-up (3-6 months after discharge

• Diaphragm Thickness

  Baseline and Post-Rehab (approx. 3-4 weeks later).

• Change in Diaphragm Mobility

  Baseline and Post-Rehab (approx. 3-4 weeks later).

• Change in Montreal Cognitive Assessment (MoCA) Score

  Baseline, Post-Rehab (approx. 3-4 weeks later), and Follow-up (3-6 months after discharge).

• Change in Mini-Mental State Examination (MMSE) Score

  Baseline, Post-Rehab (approx. 3-4 weeks later), and Follow-up (3-6 months after discharge).

Other Outcomes (3)

• Change in Apnea-Hypopnea Index (AHI)

  Baseline and Post-Rehab (approx. 3-4 weeks later).

• Change in Sex Hormones Concentration

  Baseline (fasting) and Post-Rehab (fasting, approx. 3-4 weeks later)

• Change in Myokines and Metabolic Markers Concentration

  Baseline (fasting) and Post-Rehab (fasting, approx. 3-4 weeks later).

Interventions

Rehabilitation effective OTHER

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

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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)
• Presence of a pacemaker
• Current treatment with testosterone

Sponsors & Collaborators

• Pomeranian Medical University Szczecin: lead

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: January 9, 2026
• Study Start: January 3, 2026
• Primary Completion (Estimated): June 20, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: January 9, 2026

Record last verified: 2025-12