Cardiac SurgeryK5-POSTCCHNCT07843316
Early Rehabilitation in Patients Following Major Cardiac Surgery: Changes in Functional Capacity and Energy Efficiency in Walking and ADLs.
A study testing Use of COSMED K5, a portable metabolic system that allows real-time measurement of respiratory gas exchange, ventilation, and energy expenditure during physical activities. in people with Cardiac Surgery and Median Sternotomy, run by Istituti Clinici Scientifici Maugeri SpA at 3 sites in Italy.
Trial summary
The main objective of this clinical trial is to evaluate exercise capacity before and after an inpatient or outpatient rehabilitation program in patients following major cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cardiac Surgery, Median Sternotomy
- What is being tested?
- Use of COSMED K5, a portable metabolic system that allows real-time measurement of respiratory gas exchange, ventilation, and energy expenditure during physical activities.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesItaly
- Study dates
- 1 Sep 2026to 31 Dec 2027
- Phase
- Interventional
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted to the Cardiac Rehabilitation Unit at each participating Maugeri Institute who meet all of the following criteria may be enrolled consecutively:
- Major cardiac surgery (coronary artery bypass grafting, valve surgery, or combined cardiac surgery) as the index event for the current cardiac rehabilitation episode;
- Signed informed consent;
- Participation in a complete, structured cardiac rehabilitation program (inpatient or outpatient);
- Age greater than 18 and less than 85 years (patients who have not reached their 86th birthday at the time of signing the informed consent form are considered eligible);
- Ability to ambulate independently.
Who cannot join
- Refusal to participate, including withdrawal of previously given consent;
- Concomitant acute neurological and/or orthopedic conditions that affect, impair, or alter walking ability;
- Overt cognitive impairment (severe impairment assessed via the Short Portable Mental Status Questionnaire [SPMSQ]) and/or diagnosed psychiatric disorders or psychiatric pharmacological treatment;
- Clinical instability and/or medical contraindications (hemodynamic instability: SBP <90 mmHg or >170 mmHg; DBP >100 mmHg; HR <40 bpm or HR >130 bpm; SpO₂ <90%);
- Diagnosed chronic obstructive and/or restrictive respiratory diseases currently under medical treatment.
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
ICS Maugeri SpA SB, Pavia Institute IRCCS, via Salvatore Maugeri 10
Pavia, 27100
ICS Maugeri Spa SB, Telese Institute IRCCS, Via Bagni Vecchi, 1
Telese Terme, 82037
ICS Maugeri Spa SB, Veruno Institute IRCCS, via per Revislate 13
Veruno, 28013
About this study
Official title: Early Rehabilitation, Function and Energy Efficiency After Cardiac Surgery
The main objective of this clinical trial is to evaluate exercise capacity before and after an inpatient or outpatient rehabilitation program in patients following major cardiac surgery. Secondary objectives assess baseline levels and changes post-rehabilitation in:
- Motor performance and energy efficiency during activities of daily living (ADLs).
- Energy efficiency during walking (constant-load treadmill test).
- Muscle strength and physical performance via the Short Physical Performance Battery (SPPB) and Five-Times Sit-to-Stand Test (5STS).
- Quality of life via the EuroQol questionnaire. Study Design: this 18-month, multi-center study involves several Maugeri Centres in Italy and a total of 60 patients. Participants undergo two assessment sessions (baseline and post-rehabilitation). The prescribed rehabilitation program remains strictly within routine clinical practice and will not be altered.
Read more
Measurement Device (COSMED K5): selected tests require wearing the CE-marked COSMED K5 portable metabolic analyzer. The system comprises a face mask and a lightweight backpack housing the gas analyzer. By measuring breath-by-breath gas exchange (VO2 and VCO2) alongside heart rate, respiratory rate, and blood pressure, the device precisely quantifies physiological responses to exercise. This data will help optimize recovery tracking and inform future personalized rehabilitation protocols.
Evaluations and Tests conducted at baseline and completion of the rehabilitation program:
- Six-Minute Walk Test (6MWT): Standard 6-minute walk along a 30-meter course, as required by Italian Ministry of Health guidelines.
- Constant-Load Treadmill Test: 6 minutes of walking at constant speed and incline using the K5 metabolic analyzer.
- Oxygen Kinetics Test (Cycle Ergometer): Performed in eligible patients based on initial 6MWT performance. Consists of alternating 6-minute workloads (15 W and 35 W sequence: 15-35-15-35-15-35 W) while wearing the K5 analyzer.
- GLITTRE ADL-Test: Simulates physical demands of daily living (walking, stairs, carrying weights) while using the K5 analyzer.
- Short Physical Performance Battery (SPPB): Standard battery evaluating static balance, 4-meter gait speed, and 5-times sit-to-stand performance.
- EuroQol Questionnaire: Brief self-reported quality-of-life assessment. Safety \& Risk Profile: this low-intervention study poses no additional risk beyond routine cardiac rehabilitation procedures (such as transfers, postural changes, and breathing exercises).
Read the detailed description
Cardiac rehabilitation (CR) is an established component of the multidisciplinary management of patients following major cardiac surgery. In Italy, patients undergoing coronary artery bypass grafting, valve surgery, or combined cardiac procedures are frequently referred to inpatient or outpatient CR programs shortly after surgery. Although CR is routinely provided in this setting, detailed data describing functional recovery, energy efficiency, and changes in physical performance during the early post-operative rehabilitation period remain limited.
The present study aims to characterize changes in functional capacity and physiological responses to exercise and activities of daily living following a structured CR program in patients who have recently undergone major cardiac surgery. Patients will undergo a standardized assessment at the beginning and at the completion of their rehabilitation program, while the rehabilitation intervention itself will remain unchanged and will follow the routine clinical pathway used at the participating ICS Maugeri centres.
The assessment battery includes the Six-Minute Walk Test (6MWT), a constant-load treadmill test, an oxygen kinetics test performed on a cycle ergometer, the Glittre ADL-Test, the Short Physical Performance Battery (SPPB), the Five-Times Sit-to-Stand Test (5STS), and the EuroQol questionnaire. The 6MWT is performed first and is also used to guide the subsequent exercise testing procedures according to the patient's functional capacity. The remaining tests are administered according to a predefined randomized sequence to reduce potential effects related to test order and cumulative fatigue.
Selected functional and exercise assessments are performed using the COSMED K5 portable metabolic analyzer. The device is a CE-marked portable system consisting of a face mask and a lightweight unit containing the metabolic analyzer. It enables breath-by-breath measurement of oxygen consumption (VO2), carbon dioxide production (VCO2), ventilation, and related physiological variables during walking, exercise, and activities of daily living. In this study, the K5 is used during the constant-load treadmill test, the oxygen kinetics test, and the Glittre ADL-Test to quantify physiological responses and energy efficiency.
For patients undergoing inpatient rehabilitation, the first assessment is performed within the first 96 hours after admission and the second assessment no earlier than 96 hours before discharge. For patients undergoing outpatient rehabilitation, assessments are performed during the initial and final rehabilitation sessions. Between the two assessments, patients participate in the standard CR program prescribed according to the clinical pathway for patients following major cardiac surgery.
The study is designed as a low-intervention investigation. The additional assessments are performed within the clinical rehabilitation setting and do not modify the prescribed rehabilitation program. Clinical condition is monitored throughout the testing procedures, and testing is discontinued if clinically relevant symptoms or signs of instability occur.
The study will provide information on changes in functional capacity, physical performance, quality of life, and energy efficiency during rehabilitation following major cardiac surgery. These data may help to better characterize the early functional recovery of this population and provide a basis for future studies aimed at optimizing individualized rehabilitation strategies.
- Conditions
- Cardiac Surgery, Median Sternotomy
- Being tested
- Use of COSMED K5, a portable metabolic system that allows real-time measurement of respiratory gas exchange, ventilation, and energy expenditure during physical activities.
- Keywords
- cardiac rehabilitation, major cardiac surgery, cardiopulmonary exercise testing, functional capacity, activities of daily living
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of COSMED K5, a portable metabolic system that allows real-time measurement of respiratory gas exchange, ventilation, and energy expenditure during physical activities.Diagnostic test
Two assessment sessions: baseline, end-rehabilitation.
- Six-Minute Walk Test (6MWT): Standard 6-minute walk along a 30-meter course, as required by Italian Ministry of Health guidelines.
- Constant-Load Treadmill Test: 6 minutes of walking at constant speed and incline using the K5 metabolic analyzer -wearing COSMED K5 portable metabolic analyzer.
- Oxygen Kinetics Test (Cycle Ergometer): Performed in eligible patients based on initial 6MWT performance. Consists of alternating 6-minute workloads: 15-35-15-35-15-35 W -wearing COSMED K5 portable metabolic analyzer.
- GLITTRE ADL-Test: Simulates physical demands of daily living (walking, stairs, carrying weights)-wearing COSMED K5 portable metabolic analyzer.
- Short Physical Performance Battery (SPPB): Standard battery evaluating static balance, 4-meter gait speed, and 5-times sit-to-stand performance.
- EuroQol Questionnaire: Brief self-reported quality-of-life assessment.
| Study group | Role | What they receive |
|---|---|---|
| Intervantional arm | Experimental | Evaluations and Tests conducted at baseline and completion of the rehabilitation program:
* Six-Minute Walk Test (6MWT): Standard 6-minute walk along a 30-meter course, as required by Italian Ministry of Health guidelines.
* Constant-Load Treadmill Test: 6 minutes of walking at constant speed and incline using the K5 metabolic analyzer.
* Oxygen Kinetics Test (Cycle Ergometer): Performed in eligible patients based on initial 6MWT performance. Consists of alternating 6-minute workloads (15 W and 35 W sequence: 15-35-15-35-15-35 W) while wearing the K5 analyzer.
* GLITTRE ADL-Test: Simulates physical demands of daily living (walking, stairs, carrying weights) while using the K5 analyzer.
* Short Physical Performance Battery (SPPB): Standard battery evaluating static balance, 4-meter gait speed, and 5-times sit-to-stand performance.
* EuroQol Questionnaire: Brief self-reported quality-of-life assessment. Receives: Diagnostic Test: Use of COSMED K5, a portable metabolic system that allows real-time measurement of respiratory gas exchange, ventilation, and energy expenditure during physical activities. |
What is being measured
The primary outcome is the main question the study is designed to answer.
6MWT distance
Change from baseline in Six-Minute Walk Test (6MWT) distance, measured in metres, at the end of the standard rehabilitation protocol within post-major cardiac surgery Cardiac Rehabilitation.
Measured: From beginning to the end of rehabilitation protocol at 2 weeks (inpatients) or 12 weeks (outpatients)
Secondary outcomes (5)
GLITTRE-ADL test
Change from baseline to completion of the standard rehabilitation protocol in GLITTRE ADL-Test score and corresponding peak oxygen consumption (VO2 peak) estimated via metabolic analyzer.
Measured: From beginning to the end of rehabilitation protocol at 2 weeks (inpatients) or 12 weeks (outpatients)
Constant-load treadmill test
Change from baseline to completion of the standard rehabilitation protocol in constant-load treadmill test duration/performance and corresponding peak oxygen consumption (VO2 peak) estimated via metabolic analyzer.
Measured: From beginning to the end of rehabilitation protocol at 2 weeks (inpatients) or 12 weeks (outpatients)
Interval cycle ergometer exercise test
Change from baseline to completion of the standard rehabilitation protocol in interval cycle ergometer exercise test performance and corresponding oxygen consumption (VO2 peak) estimated via metabolic analyzer (oxygen kinetics assessment).
Measured: From beginning to the end of rehabilitation protocol at 2 weeks (inpatients) or 12 weeks (outpatients)
Short Physical Performance Battery Score
Change from baseline to completion of the standard rehabilitation protocol in Short Physical Performance Battery (SPPB) total score and Five-Times Sit-to-Stand Test (5STS) time.
Measured: From beginning to the end of rehabilitation protocol at 2 weeks (inpatients) or 12 weeks (outpatients)
EuroQol Score
Change from baseline to completion of the standard rehabilitation protocol in EuroQol (EQ-5D) quality-of-life score.
Measured: From beginning to the end of rehabilitation protocol at 2 weeks (inpatients) or 12 weeks (outpatients)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start1 Sep 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Istituti Clinici Scientifici Maugeri SpAThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marco Gnemmi, Cardiology Specialist, Principal investigator, Istituti Clinici Scientifici Maugeri SpA SB, Veruno Institute IRCCSMassimo Pistono, Head of Cardiac Rehabilitation, Study chair, Istituti Clinici Scientifici Maugeri SpA SB, Veruno Institute IRCCSFabiana I Gambarin, Cardiology Specialist, Study director, Istituti Clinici Scientifici Maugeri SpA SB, Veruno Institute IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07843316
- Sponsor's protocol ID
- CE185/2026 K5-POSTCCH
- Acronym
- K5-POSTCCH
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Rehabilitation, Function and Energy Efficiency After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT07843316
- Acronym / sponsor ID
- K5-POSTCCH / CE185/2026 K5-POSTCCH
- Conditions
- Cardiac Surgery, Median Sternotomy
- Keywords
- cardiac rehabilitation, major cardiac surgery, cardiopulmonary exercise testing, functional capacity, activities of daily living
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Sep 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.
The main objective of this clinical trial is to evaluate exercise capacity before and after an inpatient or outpatient rehabilitation program in patients following major cardiac surgery. Secondary objectives assess baseline levels and changes post-rehabilitation in:
- Motor performance and energy efficiency during activities of daily living (ADLs).
- Energy efficiency during walking (constant-load treadmill test).
- Muscle strength and physical performance via the Short Physical Performance Battery (SPPB) and Five-Times Sit-to-Stand Test (5STS).
- Quality of life via the EuroQol questionnaire. Study Design: this 18-month, multi-center study involves several Maugeri Centres in Italy and a total of 60 patients. Participants undergo two assessment sessions (baseline and post-rehabilitation). The prescribed rehabilitation program remains strictly within routine clinical practice and will not be altered.
Measurement Device (COSMED K5): selected tests require wearing the CE-marked COSMED K5 portable metabolic analyzer. The system comprises a face mask and a lightweight backpack housing the gas analyzer. By measuring breath-by-breath gas exchange (VO2 and VCO2) alongside heart rate, respiratory rate, and blood pressure, the device precisely quantifies physiological responses to exercise. This data will help optimize recovery tracking and inform future personalized rehabilitation protocols.
Evaluations and Tests conducted at baseline and completion of the rehabilitation program:
- Six-Minute Walk Test (6MWT): Standard 6-minute walk along a 30-meter course, as required by Italian Ministry of Health guidelines.
- Constant-Load Treadmill Test: 6 minutes of walking at constant speed and incline using the K5 metabolic analyzer.
- Oxygen Kinetics Test (Cycle Ergometer): Performed in eligible patients based on initial 6MWT performance. Consists of alternating 6-minute workloads (15 W and 35 W sequence: 15-35-15-35-15-35 W) while wearing the K5 analyzer.
- GLITTRE ADL-Test: Simulates physical demands of daily living (walking, stairs, carrying weights) while using the K5 analyzer.
- Short Physical Performance Battery (SPPB): Standard battery evaluating static balance, 4-meter gait speed, and 5-times sit-to-stand performance.
- EuroQol Questionnaire: Brief self-reported quality-of-life assessment. Safety \& Risk Profile: this low-intervention study poses no additional risk beyond routine cardiac rehabilitation procedures (such as transfers, postural changes, and breathing exercises).
Detailed description
Cardiac rehabilitation (CR) is an established component of the multidisciplinary management of patients following major cardiac surgery. In Italy, patients undergoing coronary artery bypass grafting, valve surgery, or combined cardiac procedures are frequently referred to inpatient or outpatient CR programs shortly after surgery. Although CR is routinely provided in this setting, detailed data describing functional recovery, energy efficiency, and changes in physical performance during the early post-operative rehabilitation period remain limited.
The present study aims to characterize changes in functional capacity and physiological responses to exercise and activities of daily living following a structured CR program in patients who have recently undergone major cardiac surgery. Patients will undergo a standardized assessment at the beginning and at the completion of their rehabilitation program, while the rehabilitation intervention itself will remain unchanged and will follow the routine clinical pathway used at the participating ICS Maugeri centres.
The assessment battery includes the Six-Minute Walk Test (6MWT), a constant-load treadmill test, an oxygen kinetics test performed on a cycle ergometer, the Glittre ADL-Test, the Short Physical Performance Battery (SPPB), the Five-Times Sit-to-Stand Test (5STS), and the EuroQol questionnaire. The 6MWT is performed first and is also used to guide the subsequent exercise testing procedures according to the patient's functional capacity. The remaining tests are administered according to a predefined randomized sequence to reduce potential effects related to test order and cumulative fatigue.
Selected functional and exercise assessments are performed using the COSMED K5 portable metabolic analyzer. The device is a CE-marked portable system consisting of a face mask and a lightweight unit containing the metabolic analyzer. It enables breath-by-breath measurement of oxygen consumption (VO2), carbon dioxide production (VCO2), ventilation, and related physiological variables during walking, exercise, and activities of daily living. In this study, the K5 is used during the constant-load treadmill test, the oxygen kinetics test, and the Glittre ADL-Test to quantify physiological responses and energy efficiency.
For patients undergoing inpatient rehabilitation, the first assessment is performed within the first 96 hours after admission and the second assessment no earlier than 96 hours before discharge. For patients undergoing outpatient rehabilitation, assessments are performed during the initial and final rehabilitation sessions. Between the two assessments, patients participate in the standard CR program prescribed according to the clinical pathway for patients following major cardiac surgery.
The study is designed as a low-intervention investigation. The additional assessments are performed within the clinical rehabilitation setting and do not modify the prescribed rehabilitation program. Clinical condition is monitored throughout the testing procedures, and testing is discontinued if clinically relevant symptoms or signs of instability occur.
The study will provide information on changes in functional capacity, physical performance, quality of life, and energy efficiency during rehabilitation following major cardiac surgery. These data may help to better characterize the early functional recovery of this population and provide a basis for future studies aimed at optimizing individualized rehabilitation strategies.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervantional arm | Experimental | Diagnostic Test: Use of COSMED K5, a portable metabolic system that allows real-time measurement of respiratory gas exchange, ventilation, and energy expenditure during physical activities.Evaluations and Tests conducted at baseline and completion of the rehabilitation program: * Six-Minute Walk Test (6MWT): Standard 6-minute walk along a 30-meter course, as required by Italian Ministry of Health guidelines. * Constant-Load Treadmill Test: 6 minutes of walking at constant speed and incline using the K5 metabolic analyzer. * Oxygen Kinetics Test (Cycle Ergometer): Performed in eligible patients based on initial 6MWT performance. Consists of alternating 6-minute workloads (15 W and 35 W sequence: 15-35-15-35-15-35 W) while wearing the K5 analyzer. * GLITTRE ADL-Test: Simulates physical demands of daily living (walking, stairs, carrying weights) while using the K5 analyzer. * Short Physical Performance Battery (SPPB): Standard battery evaluating static balance, 4-meter gait speed, and 5-times sit-to-stand performance. * EuroQol Questionnaire: Brief self-reported quality-of-life assessment. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients admitted to the Cardiac Rehabilitation Unit at each participating Maugeri Institute who meet all of the following criteria may be enrolled consecutively:
- Major cardiac surgery (coronary artery bypass grafting, valve surgery, or combined cardiac surgery) as the index event for the current cardiac rehabilitation episode;
- Signed informed consent;
- Participation in a complete, structured cardiac rehabilitation program (inpatient or outpatient);
- Age greater than 18 and less than 85 years (patients who have not reached their 86th birthday at the time of signing the informed consent form are considered eligible);
Key exclusion criteria (5 listed)
- Refusal to participate, including withdrawal of previously given consent;
- Concomitant acute neurological and/or orthopedic conditions that affect, impair, or alter walking ability;
- Overt cognitive impairment (severe impairment assessed via the Short Portable Mental Status Questionnaire [SPMSQ]) and/or diagnosed psychiatric disorders or psychiatric pharmacological treatment;
- Clinical instability and/or medical contraindications (hemodynamic instability: SBP <90 mmHg or >170 mmHg; DBP >100 mmHg; HR <40 bpm or HR >130 bpm; SpO₂ <90%);
- Diagnosed chronic obstructive and/or restrictive respiratory diseases currently under medical treatment.
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 |
|---|---|---|
| Use of COSMED K5, a portable metabolic system that allows real-time measurement of respiratory gas exchange, ventilation, and energy expenditure during physical activities.Two assessment sessions: baseline, end-rehabilitation. * Six-Minute Walk Test (6MWT): Standard 6-minute walk along a 30-meter course, as required by Italian Ministry of Health guidelines. * Constant-Load Treadmill Test: 6 minutes of walking at constant speed and incline using the K5 metabolic analyzer -wearing COSMED K5 portable metabolic analyzer. * Oxygen Kinetics Test (Cycle Ergometer): Performed in eligible patients based on initial 6MWT performance. Consists of alternating 6-minute workloads: 15-35-15-35-15-35 W -wearing COSMED K5 portable metabolic analyzer. * GLITTRE ADL-Test: Simulates physical demands of daily living (walking, stairs, carrying weights)-wearing COSMED K5 portable metabolic analyzer. * Short Physical Performance Battery (SPPB): Standard battery evaluating static balance, 4-meter gait speed, and 5-times sit-to-stand performance. * EuroQol Questionnaire: Brief self-reported quality-of-life assessment. | Diagnostic test | Intervantional arm |
Primary outcome
6MWT distance
Time frame: From beginning to the end of rehabilitation protocol at 2 weeks (inpatients) or 12 weeks (outpatients)
Change from baseline in Six-Minute Walk Test (6MWT) distance, measured in metres, at the end of the standard rehabilitation protocol within post-major cardiac surgery Cardiac Rehabilitation.
5 secondary outcomes
GLITTRE-ADL test
Time frame: From beginning to the end of rehabilitation protocol at 2 weeks (inpatients) or 12 weeks (outpatients)
Constant-load treadmill test
Time frame: From beginning to the end of rehabilitation protocol at 2 weeks (inpatients) or 12 weeks (outpatients)
Interval cycle ergometer exercise test
Time frame: From beginning to the end of rehabilitation protocol at 2 weeks (inpatients) or 12 weeks (outpatients)
Short Physical Performance Battery Score
Time frame: From beginning to the end of rehabilitation protocol at 2 weeks (inpatients) or 12 weeks (outpatients)
EuroQol Score
Time frame: From beginning to the end of rehabilitation protocol at 2 weeks (inpatients) or 12 weeks (outpatients)
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 5 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Marco Gnemmi, Cardiology Specialist principal investigator
Istituti Clinici Scientifici Maugeri SpA SB, Veruno Institute IRCCS
Massimo Pistono, Head of Cardiac Rehabilitation study chair
Istituti Clinici Scientifici Maugeri SpA SB, Veruno Institute IRCCS
Fabiana I Gambarin, Cardiology Specialist study director
Istituti Clinici Scientifici Maugeri SpA SB, Veruno Institute IRCCS
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of COSMED K5, a portable metabolic system that allows real-time measurement of respiratory gas exchange, ventilation, and energy expenditure during physical activities. in people with Cardiac Surgery and Median Sternotomy, run by Istituti Clinici Scientifici Maugeri SpA at 3 sites in Italy.
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 6 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
6MWT distance (time frame: From beginning to the end of rehabilitation protocol at 2 weeks (inpatients) or 12 weeks (outpatients)). 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 5 Oct 2026.