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

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

118

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Pavia, Italy, 27100
        • Istituti Clinici Scientifici Maugeri IRCCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Equation-Based Prescription
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.
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.
Experimental: Symptoms-Based Prescription
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to 2 weeks (end of intervention)
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
Baseline to 2 weeks (end of intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2022

Primary Completion (Actual)

April 30, 2024

Study Completion (Actual)

July 15, 2024

Study Registration Dates

First Submitted

February 23, 2026

First Submitted That Met QC Criteria

February 23, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

March 3, 2026

Last Update Submitted That Met QC Criteria

March 2, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • ICS Maugeri
  • Ethics Committee (Other Identifier: Marmara University Faculty of Dentistry)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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