Post-cardiac SurgeryNCT07440407
Aerobic Reconditioning After Cardiac Surgery Using a Predictive Exercise Model
A study testing Equation-Based Aerobic Exercise Prescription and Symptoms-Based Aerobic Exercise Prescription in people with Post-cardiac Surgery and Rehabilitation, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
Trial summary
Brief Summary After heart surgery, aerobic exercise is essential for recovery. Traditional exercise planning uses a cardiopulmonary exercise test (CPET), which may be unavailable early after surgery. This study tested a six-minute walk test (6MWT)-based method. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-cardiac Surgery, Rehabilitation
- What is being tested?
- Equation-Based Aerobic Exercise Prescription and Symptoms-Based Aerobic Exercise Prescription
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteItaly
- Study dates
- 30 Mar 2022to 15 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (≥18 years- 65 years) admitted to cardiac rehabilitation following cardiac surgery
- Clinically stable condition at the time of enrollment
- Ability to understand and sign informed consent
- ability to perform a six-minute walking test (6MWT) without assistive devices
Who cannot join
- Severe cognitive impairment preventing participation
- Unstable clinical conditions or acute complications
- Severe comorbidities limiting participation in rehabilitation
- Refusal or inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aerobic Reconditioning in Post-Cardiac Surgery Patients: A Pragmatic Real-World Application of a Predictive Equation for Exercise Prescription
Brief Summary
After heart surgery, aerobic exercise is essential for recovery. Traditional exercise planning uses a cardiopulmonary exercise test (CPET), which may be unavailable early after surgery. This study tested a six-minute walk test (6MWT)-based method.
Read more
Patients aged 30-65 were randomized to either 6MWT-guided or symptom-guided exercise. They completed 14 supervised cycling sessions over two weeks. Safety, exercise progression, training volume, functional capacity, physical performance, and quality of life were measured.
Out of 118 patients, 109 completed the program with no serious exercise-related events. The 6MWT group started at higher intensity and achieved greater training volume. Both groups improved similarly in functional and quality-of-life measures, showing the 6MWT method is safe, feasible, and non-inferior to the traditional approach.
Read the detailed description
Aerobic exercise is essential in early cardiac rehabilitation after cardiac surgery. While cardiopulmonary exercise testing (CPET) is the reference standard, it is often impractical in the early postoperative phase. This single-center randomized controlled trial evaluated a six-minute walk test (6MWT)-derived predictive equation for exercise prescription versus a traditional symptoms-based approach (Borg CR10 scale).
Patients aged 30-65 years, admitted to inpatient rehabilitation one week after cardiac surgery (CABG, valve, or combined), were randomized 1:1 to 14 supervised cycling sessions over two weeks. Outcomes included feasibility, safety, workload progression, functional capacity (6MWT), physical performance (SPPB), and quality of life (EQ-5D).
Of 118 enrolled patients, 109 completed the program. No serious exercise-related adverse events occurred. The 6MWT-based group started at higher workloads and achieved greater cumulative training volume. Both groups improved in functional capacity, physical performance, and quality of life, demonstrating non-inferiority of the 6MWT method.
The 6MWT-derived predictive equation provides a safe, feasible, and effective alternative for aerobic exercise prescription when CPET is unavailable.
- Conditions
- Post-cardiac Surgery, Rehabilitation
- Being tested
- Equation-Based Aerobic Exercise Prescription, Symptoms-Based Aerobic Exercise Prescription
- Keywords
- Aerobic Exercise, Exercise Prescription, 6-Minute Walk Test, Functional Recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Equation-Based Aerobic Exercise PrescriptionOther
Patients performed 14 supervised cycling sessions over two weeks. Exercise workload was prescribed using a predictive equation derived from the six-minute walk test (6MWT) to estimate maximal workload. Progression was individualized based on calculated target workload.
Symptoms-Based Aerobic Exercise PrescriptionOther
Patients performed 14 supervised cycling sessions over two weeks. Exercise workload was guided by perceived exertion using the Borg CR10 scale, targeting a rating of 4-6. Workload adjustments were made according to patient-reported symptom
| Study group | Role | What they receive |
|---|---|---|
| Equation-Based Prescription | Experimental | Participants in this group receive an aerobic exercise program based on a predictive equation derived from the six-minute walk test (6MWT). The maximal workload is estimated from 6MWT performance, and participants complete 14 supervised cycling sessions over two weeks. Exercise intensity is individually tailored and progressively increased according to the predictive equation. Receives: Other: Equation-Based Aerobic Exercise Prescription |
| Symptoms-Based Prescription | Experimental | Participants in this group receive an aerobic exercise program guided by perceived exertion, using the Borg CR10 scale (target 4-6). They complete 14 supervised cycling sessions over two weeks, with exercise intensity adjusted according to symptom feedback during each session. Receives: Other: Symptoms-Based Aerobic Exercise Prescription |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Capacity (6-Minute Walk Test)
Distance covered during the 6-minute walk test (6MWT) to assess improvements in functional capacity following aerobic exercise prescription after cardiac surgery.
Measured: Baseline to 2 weeks (end of intervention)
Functional Capacity (6-Minute Walk Test)
Distance covered during the 6-minute walk test (6MWT) to assess improvements in functional capacity following aerobic exercise prescription
Measured: Baseline to 2 weeks (end of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start30 Mar 2022
- Primary completion30 Apr 2024
- Study completion15 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-cardiac SurgeryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single-center, randomized, controlled, parallel-group study. Participants are randomly assigned in a 1:1 ratio to either the equation-based aerobic exercise prescription group, which uses a predictive equation derived from the six-minute walk test (6MWT), or the symptoms-based prescription group, guided by perceived exertion (Borg CR10). Each participant completes 14 supervised cycling sessions over two weeks. The study evaluates feasibility, safety, workload progression, functional capacity, physical performance, and quality of life.
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07440407
- Sponsor's protocol ID
- ICS Maugeri
- Other IDs
- Ethics Committee
- Status last verified
- Feb 2026
- First submitted
- 23 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aerobic Reconditioning in Post-Cardiac Surgery Patients: A Pragmatic Real-World Application of a Predictive Equation for Exercise Prescription
- ClinicalTrials.gov ID
- NCT07440407
- Acronym / sponsor ID
- ICS Maugeri
- Conditions
- Post-cardiac Surgery, Rehabilitation
- Keywords
- Aerobic Exercise, Exercise Prescription, 6-Minute Walk Test, Functional Recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 27 Feb 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.
Brief Summary
After heart surgery, aerobic exercise is essential for recovery. Traditional exercise planning uses a cardiopulmonary exercise test (CPET), which may be unavailable early after surgery. This study tested a six-minute walk test (6MWT)-based method.
Patients aged 30-65 were randomized to either 6MWT-guided or symptom-guided exercise. They completed 14 supervised cycling sessions over two weeks. Safety, exercise progression, training volume, functional capacity, physical performance, and quality of life were measured.
Out of 118 patients, 109 completed the program with no serious exercise-related events. The 6MWT group started at higher intensity and achieved greater training volume. Both groups improved similarly in functional and quality-of-life measures, showing the 6MWT method is safe, feasible, and non-inferior to the traditional approach.
Detailed description
Aerobic exercise is essential in early cardiac rehabilitation after cardiac surgery. While cardiopulmonary exercise testing (CPET) is the reference standard, it is often impractical in the early postoperative phase. This single-center randomized controlled trial evaluated a six-minute walk test (6MWT)-derived predictive equation for exercise prescription versus a traditional symptoms-based approach (Borg CR10 scale).
Patients aged 30-65 years, admitted to inpatient rehabilitation one week after cardiac surgery (CABG, valve, or combined), were randomized 1:1 to 14 supervised cycling sessions over two weeks. Outcomes included feasibility, safety, workload progression, functional capacity (6MWT), physical performance (SPPB), and quality of life (EQ-5D).
Of 118 enrolled patients, 109 completed the program. No serious exercise-related adverse events occurred. The 6MWT-based group started at higher workloads and achieved greater cumulative training volume. Both groups improved in functional capacity, physical performance, and quality of life, demonstrating non-inferiority of the 6MWT method.
The 6MWT-derived predictive equation provides a safe, feasible, and effective alternative for aerobic exercise prescription when CPET is unavailable.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a single-center, randomized, controlled, parallel-group study. Participants are randomly assigned in a 1:1 ratio to either the equation-based aerobic exercise prescription group, which uses a predictive equation derived from the six-minute walk test (6MWT), or the symptoms-based prescription group, guided by perceived exertion (Borg CR10). Each participant completes 14 supervised cycling sessions over two weeks. The study evaluates feasibility, safety, workload progression, functional capacity, physical performance, and quality of life.
| Arm | Type | Receives |
|---|---|---|
| Equation-Based Prescription | Experimental | Other: Equation-Based Aerobic Exercise PrescriptionParticipants in this group receive an aerobic exercise program based on a predictive equation derived from the six-minute walk test (6MWT). The maximal workload is estimated from 6MWT performance, and participants complete 14 supervised cycling sessions over two weeks. Exercise intensity is individually tailored and progressively increased according to the predictive equation. |
| Symptoms-Based Prescription | Experimental | Other: Symptoms-Based Aerobic Exercise PrescriptionParticipants in this group receive an aerobic exercise program guided by perceived exertion, using the Borg CR10 scale (target 4-6). They complete 14 supervised cycling sessions over two weeks, with exercise intensity adjusted according to symptom feedback during each session. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients (≥18 years- 65 years) admitted to cardiac rehabilitation following cardiac surgery
- Clinically stable condition at the time of enrollment
- Ability to understand and sign informed consent
- ability to perform a six-minute walking test (6MWT) without assistive devices
Key exclusion criteria (4 listed)
- Severe cognitive impairment preventing participation
- Unstable clinical conditions or acute complications
- Severe comorbidities limiting participation in rehabilitation
- Refusal or inability to provide informed consent
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 |
|---|---|---|
| Equation-Based Aerobic Exercise PrescriptionPatients performed 14 supervised cycling sessions over two weeks. Exercise workload was prescribed using a predictive equation derived from the six-minute walk test (6MWT) to estimate maximal workload. Progression was individualized based on calculated target workload. | Other | Equation-Based Prescription |
| Symptoms-Based Aerobic Exercise PrescriptionPatients performed 14 supervised cycling sessions over two weeks. Exercise workload was guided by perceived exertion using the Borg CR10 scale, targeting a rating of 4-6. Workload adjustments were made according to patient-reported symptom | Other | Symptoms-Based Prescription |
Primary outcome
Functional Capacity (6-Minute Walk Test)
Time frame: Baseline to 2 weeks (end of intervention)
Distance covered during the 6-minute walk test (6MWT) to assess improvements in functional capacity following aerobic exercise prescription after cardiac surgery.
Functional Capacity (6-Minute Walk Test)
Time frame: Baseline to 2 weeks (end of intervention)
Distance covered during the 6-minute walk test (6MWT) to assess improvements in functional capacity following aerobic exercise prescription
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Equation-Based Aerobic Exercise Prescription and Symptoms-Based Aerobic Exercise Prescription in people with Post-cardiac Surgery and Rehabilitation, run by Istituti Clinici Scientifici Maugeri SpA at 1 site 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Functional Capacity (6-Minute Walk Test) (time frame: Baseline to 2 weeks (end of intervention)). The study lists 2 primary outcomes in all. 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 3 Mar 2026.