Aerobic Reconditioning After Cardiac Surgery Using a Predictive Exercise Model

NCT07440407 | Completed

• 2 other identifiers: ICS MaugeriEthics Committee
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-cardiac Surgery; Rehabilitation

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  Baseline to 2 weeks (end of intervention)

Study Arms (2)

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.

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.

Other: Symptoms-Based Aerobic Exercise Prescription

Interventions

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.

Equation-Based Prescription

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

Symptoms-Based Prescription

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead

Study Sites (1)

Istituti Clinici Scientifici Maugeri IRCCS

Pavia, 27100, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: February 27, 2026
• Study Start: March 30, 2022
• Primary Completion: April 30, 2024
• Study Completion: July 15, 2024
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)