Early Rehabilitation in Patients Following Major Cardiac Surgery: Changes in Functional Capacity and Energy Efficiency in Walking and ADLs.

NCT07843316 | Active Not Recruiting

• 1 other identifier: CE185/2026 K5-POSTCCH
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief Summary

The main objective of this clinical trial is to evaluate exercise capacity before and after an inpatient or outpatient rehabilitation program in patients following major cardiac surgery. Secondary objectives assess baseline levels and changes post-rehabilitation in:

• Motor performance and energy efficiency during activities of daily living (ADLs).
• Energy efficiency during walking (constant-load treadmill test).
• Muscle strength and physical performance via the Short Physical Performance Battery (SPPB) and Five-Times Sit-to-Stand Test (5STS).
• Quality of life via the EuroQol questionnaire. Study Design: this 18-month, multi-center study involves several Maugeri Centres in Italy and a total of 60 patients. Participants undergo two assessment sessions (baseline and post-rehabilitation). The prescribed rehabilitation program remains strictly within routine clinical practice and will not be altered. Measurement Device (COSMED K5): selected tests require wearing the CE-marked COSMED K5 portable metabolic analyzer. The system comprises a face mask and a lightweight backpack housing the gas analyzer. By measuring breath-by-breath gas exchange (VO2 and VCO2) alongside heart rate, respiratory rate, and blood pressure, the device precisely quantifies physiological responses to exercise. This data will help optimize recovery tracking and inform future personalized rehabilitation protocols. Evaluations and Tests conducted at baseline and completion of the rehabilitation program:
• Six-Minute Walk Test (6MWT): Standard 6-minute walk along a 30-meter course, as required by Italian Ministry of Health guidelines.
• Constant-Load Treadmill Test: 6 minutes of walking at constant speed and incline using the K5 metabolic analyzer.
• Oxygen Kinetics Test (Cycle Ergometer): Performed in eligible patients based on initial 6MWT performance. Consists of alternating 6-minute workloads (15 W and 35 W sequence: 15-35-15-35-15-35 W) while wearing the K5 analyzer.
• GLITTRE ADL-Test: Simulates physical demands of daily living (walking, stairs, carrying weights) while using the K5 analyzer.
• Short Physical Performance Battery (SPPB): Standard battery evaluating static balance, 4-meter gait speed, and 5-times sit-to-stand performance.
• EuroQol Questionnaire: Brief self-reported quality-of-life assessment. Safety \& Risk Profile: this low-intervention study poses no additional risk beyond routine cardiac rehabilitation procedures (such as transfers, postural changes, and breathing exercises).

Conditions

Cardiac Surgery; Median Sternotomy

Keywords

cardiac rehabilitation; major cardiac surgery; cardiopulmonary exercise testing; functional capacity; activities of daily living

Outcome Measures

Primary Outcomes (1)

• 6MWT distance

  Change from baseline in Six-Minute Walk Test (6MWT) distance, measured in metres, at the end of the standard rehabilitation protocol within post-major cardiac surgery Cardiac Rehabilitation.

  From beginning to the end of rehabilitation protocol at 2 weeks (inpatients) or 12 weeks (outpatients)

Secondary Outcomes (5)

• GLITTRE-ADL test

  From beginning to the end of rehabilitation protocol at 2 weeks (inpatients) or 12 weeks (outpatients)

• Constant-load treadmill test

  From beginning to the end of rehabilitation protocol at 2 weeks (inpatients) or 12 weeks (outpatients)

• Interval cycle ergometer exercise test

  From beginning to the end of rehabilitation protocol at 2 weeks (inpatients) or 12 weeks (outpatients)

• Short Physical Performance Battery Score

  From beginning to the end of rehabilitation protocol at 2 weeks (inpatients) or 12 weeks (outpatients)

• EuroQol Score

  From beginning to the end of rehabilitation protocol at 2 weeks (inpatients) or 12 weeks (outpatients)

Study Arms (1)

Intervantional arm

EXPERIMENTAL

Evaluations and Tests conducted at baseline and completion of the rehabilitation program: * Six-Minute Walk Test (6MWT): Standard 6-minute walk along a 30-meter course, as required by Italian Ministry of Health guidelines. * Constant-Load Treadmill Test: 6 minutes of walking at constant speed and incline using the K5 metabolic analyzer. * Oxygen Kinetics Test (Cycle Ergometer): Performed in eligible patients based on initial 6MWT performance. Consists of alternating 6-minute workloads (15 W and 35 W sequence: 15-35-15-35-15-35 W) while wearing the K5 analyzer. * GLITTRE ADL-Test: Simulates physical demands of daily living (walking, stairs, carrying weights) while using the K5 analyzer. * Short Physical Performance Battery (SPPB): Standard battery evaluating static balance, 4-meter gait speed, and 5-times sit-to-stand performance. * EuroQol Questionnaire: Brief self-reported quality-of-life assessment.

Diagnostic Test: Use of COSMED K5, a portable metabolic system that allows real-time measurement of respiratory gas exchange, ventilation, and energy expenditure during physical activities.

Interventions

Use of COSMED K5, a portable metabolic system that allows real-time measurement of respiratory gas exchange, ventilation, and energy expenditure during physical activities. DIAGNOSTIC_TEST

Two assessment sessions: baseline, end-rehabilitation. * Six-Minute Walk Test (6MWT): Standard 6-minute walk along a 30-meter course, as required by Italian Ministry of Health guidelines. * Constant-Load Treadmill Test: 6 minutes of walking at constant speed and incline using the K5 metabolic analyzer -wearing COSMED K5 portable metabolic analyzer. * Oxygen Kinetics Test (Cycle Ergometer): Performed in eligible patients based on initial 6MWT performance. Consists of alternating 6-minute workloads: 15-35-15-35-15-35 W -wearing COSMED K5 portable metabolic analyzer. * GLITTRE ADL-Test: Simulates physical demands of daily living (walking, stairs, carrying weights)-wearing COSMED K5 portable metabolic analyzer. * Short Physical Performance Battery (SPPB): Standard battery evaluating static balance, 4-meter gait speed, and 5-times sit-to-stand performance. * EuroQol Questionnaire: Brief self-reported quality-of-life assessment.

Intervantional arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients admitted to the Cardiac Rehabilitation Unit at each participating Maugeri Institute who meet all of the following criteria may be enrolled consecutively:
• Major cardiac surgery (coronary artery bypass grafting, valve surgery, or combined cardiac surgery) as the index event for the current cardiac rehabilitation episode;
• Signed informed consent;
• Participation in a complete, structured cardiac rehabilitation program (inpatient or outpatient);
• Age greater than 18 and less than 85 years (patients who have not reached their 86th birthday at the time of signing the informed consent form are considered eligible);
• Ability to ambulate independently.

You may not qualify if:

• Refusal to participate, including withdrawal of previously given consent;
• Concomitant acute neurological and/or orthopedic conditions that affect, impair, or alter walking ability;
• Overt cognitive impairment (severe impairment assessed via the Short Portable Mental Status Questionnaire \[SPMSQ\]) and/or diagnosed psychiatric disorders or psychiatric pharmacological treatment;
• Clinical instability and/or medical contraindications (hemodynamic instability: SBP \<90 mmHg or \>170 mmHg; DBP \>100 mmHg; HR \<40 bpm or HR \>130 bpm; SpO₂ \<90%);
• Diagnosed chronic obstructive and/or restrictive respiratory diseases currently under medical treatment.

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead

Study Sites (3)

ICS Maugeri SpA SB, Pavia Institute IRCCS, via Salvatore Maugeri 10

Pavia, 27100, Italy

Location

ICS Maugeri Spa SB, Telese Institute IRCCS, Via Bagni Vecchi, 1

Telese Terme, 82037, Italy

Location

ICS Maugeri Spa SB, Veruno Institute IRCCS, via per Revislate 13

Veruno, 28013, Italy

Location

MeSH Terms

Interventions

Inhalation

Intervention Hierarchy (Ancestors)

Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Marco Gnemmi, Cardiology Specialist

  Istituti Clinici Scientifici Maugeri SpA SB, Veruno Institute IRCCS

  PRINCIPAL INVESTIGATOR

• Massimo Pistono, Head of Cardiac Rehabilitation

  Istituti Clinici Scientifici Maugeri SpA SB, Veruno Institute IRCCS

  STUDY CHAIR

• Fabiana I Gambarin, Cardiology Specialist

  Istituti Clinici Scientifici Maugeri SpA SB, Veruno Institute IRCCS

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2026
• First Posted: September 28, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 28, 2026

Record last verified: 2026-09

Locations

IT (3)