NCT07440407

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: Istituti Clinici Scientifici Maugeri SpA · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Post-cardiac Surgery
• Rehabilitation

Interventions

Type	Name	Description
OTHER	Equation-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.
OTHER	Symptoms-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

Timeline

• Start date: 2022-03-30
• Primary completion: 2024-04-30
• Completion: 2024-07-15
• First posted: 2026-02-27
• Last updated: 2026-03-03

Locations

1 site across 1 country: Italy