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Completed

NCT Number: NCT07440407

Aerobic Reconditioning After Cardiac Surgery Using a Predictive Exercise Model

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituti Clinici Scientifici Maugeri IRCCS

Pavia, 27100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Equation-Based Aerobic Exercise Prescription

Other

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 Prescription

Other

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

Primary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

Istituti Clinici Scientifici Maugeri SpA

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 27, 2026
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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