- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
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
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Pavia, Italy, 27100
- Istituti Clinici Scientifici Maugeri IRCCS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Rehabilitation
-
Mississippi State UniversityUniversity of Mississippi Medical CenterNot yet recruitingPostoperative Rehabilitation | Hand Injury RehabilitationUnited States
-
Ankara Etlik City HospitalRecruitingStroke Rehabilitation | Stroke Rehabilitation and CaregiversTurkey (Türkiye)
-
Westfälische Wilhelms-Universität MünsterNational Paralympic Committee Germany (NPCG)CompletedCardiac Rehabilitation | Feasibility Studies | Organization and Administration | Rehabilitation ExerciseGermany
-
Asan Medical CenterRecruitingPulmonary Rehabilitation | Cardiac RehabilitationKorea, Republic of
-
University Hospital, ToursCompletedPulmonary Rehabilitation | Respiratory RehabilitationFrance
-
Richard Watson, PTCompletedMedial Patellar Femoral Ligament Reconstruction Rehabilitation | Anterior Cruciate Ligament Reconstruction RehabilitationUnited States
-
Suleyman Demirel UniversityCompleted
-
Orton Orthopaedic HospitalCompleted
-
Stanford UniversityRecruitingRehabilitationUnited States
-
Cairo UniversityRecruiting
Clinical Trials on Equation-Based Aerobic Exercise Prescription
-
Vanderbilt UniversityJohns Hopkins UniversityWithdrawnRadiotherapy | Head and Neck NeoplasmUnited States
-
Dartmouth-Hitchcock Medical CenterNational Cancer Institute (NCI)Recruiting
-
Nova Scotia Health AuthorityCompleted
-
National Defense Medical Center, TaiwanMinistry of Science and Technology, TaiwanRecruitingCardiology | PsychiatryTaiwan
-
Universidad de ColimaPedro Julian Flores Moreno; Nelson Enrique Ramos CuevasNot yet recruitingHyperglycemia | Hypertriglyceridemia | Blood Pressure Disorders | Metabolic Disorders | Abdominal Obesity | HDL-DeficiencyMexico
-
Acibadem UniversityCompletedMultiple SclerosisTurkey (Türkiye)
-
National Taiwan University HospitalCompletedDiabetes and Healthy Control | FTO Gene Expression | Aerobic Exercise Intervention or Home Exercise | Pre-training and Post-trainingTaiwan
-
Bezmialem Vakif UniversityThe Scientific and Technological Research Council of TurkeyCompletedDown Syndrome | Cognitive Function | Functional Capacity | Aerobic Exercise | Physical Fitness | Virtual Reality Based Therapy | ExergameTurkey (Türkiye)
-
Lincoln University CollegeWuhan Technical UniversityCompletedSelf-Perception | Mental Fatigue | Psychological Stress | Autonomic Nervous System Function | Post-Exercise Recovery | Healthy University StudentsChina
-
Universidade Metodista de PiracicabaCompletedArteriosclerosis, CoronaryBrazil