RehabilitationNCT07328789
Factors Influencing Cardiac Rehabilitation Success
An observational study of Rehabilitation, run by Pomeranian Medical University Szczecin.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Rehabilitation
- What is being tested?
- Rehabilitation effective
- Type of treatment
- Pill or oral medicine
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 3 Jan 2026to 1 Jul 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Assessment of the Effectiveness of Comprehensive Cardiac Rehabilitation and Identification of Factors Modulating Its Results
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).
Read more
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).
Read the detailed description
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:
- 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).
- 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.
- 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.
- Conditions
- Rehabilitation
- Being tested
- Rehabilitation effective
- Keywords
- Cardiac Rehabilitation, Sex Hormones, Cognitive Dysfunction
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation effectiveOther
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Baseline, Post-Rehab (approx. 3-4 weeks later), and Follow-up (3-6 months after discharge).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start3 Jan 2026 (estimated)
- Primary completion20 Jun 2029 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pomeranian Medical University Szczecin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aleksandra Rył, Pomeranian Medical University Szczecin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07328789
- Sponsor's protocol ID
- KB-006/65/2025
- Status last verified
- Dec 2025
- First submitted
- 1 Dec 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effectiveness of Comprehensive Cardiac Rehabilitation and Identification of Factors Modulating Its Results
- ClinicalTrials.gov ID
- NCT07328789
- Acronym / sponsor ID
- KB-006/65/2025
- Conditions
- Rehabilitation
- Keywords
- Cardiac Rehabilitation, Sex Hormones, Cognitive Dysfunction
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Pomeranian Medical University SzczecinUniversity, hospital or other
- Study start
- 3 Jan 2026 (estimated)
- Primary completion
- 20 Jun 2029 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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:
- 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).
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rehabilitation effectiveThis 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 | Other | – |
Primary outcome
Change in Physical Capacity (6MWT)
Time frame: Baseline (start of hospitalization/T0) and Post-Rehab (end of cardiac rehabilitation/T1, approximately 3-4 weeks later)
Distance walked in 6 minutes measured in meters using the 6-Minute Walk Test (6MWT). The test reflects objective functional improvement in physical capacity.
5 secondary outcomes
Change in Psychological Status (HADS)
Time frame: Baseline, Post-Rehab (approx. 3-4 weeks later), and Follow-up (3-6 months after discharge
Diaphragm Thickness
Time frame: Baseline and Post-Rehab (approx. 3-4 weeks later).
Change in Diaphragm Mobility
Time frame: Baseline and Post-Rehab (approx. 3-4 weeks later).
Change in Montreal Cognitive Assessment (MoCA) Score
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
Time frame: Baseline, Post-Rehab (approx. 3-4 weeks later), and Follow-up (3-6 months after discharge).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Rehabilitation, run by Pomeranian Medical University Szczecin.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Physical Capacity (6MWT) (time frame: Baseline (start of hospitalization/T0) and Post-Rehab (end of cardiac rehabilitation/T1, approximately 3-4 weeks later)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.