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Aerobic Reconditioning After Cardiac Surgery Using a Predictive Exercise Model

Aerobic Reconditioning in Post-Cardiac Surgery Patients: A Pragmatic Real-World Application of a Predictive Equation for Exercise Prescription

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07440407
Enrollment
118
Registered
2026-02-27
Start date
2022-03-30
Completion date
2024-07-15
Last updated
2026-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-cardiac Surgery, Rehabilitation

Keywords

Aerobic Exercise, Exercise Prescription, 6-Minute Walk Test, Functional Recovery

Brief 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. 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.

Interventions

OTHEREquation-Based Aerobic Exercise Prescription

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.

OTHERSymptoms-Based Aerobic Exercise Prescription

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

Sponsors

Istituti Clinici Scientifici Maugeri SpA
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Severe cognitive impairment preventing participation * Unstable clinical conditions or acute complications * Severe comorbidities limiting participation in rehabilitation * Refusal or inability to provide informed consent

Design outcomes

Primary

MeasureTime frameDescription
Functional Capacity (6-Minute Walk Test)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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026