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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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).

Eligibility

Primary outcome measure(s)

• 6MWT distance — From beginning to the end of rehabilitation protocol at 2 weeks (inpatients) or 12 weeks (outpatients)
  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.

Trial sites (3)

More Istituti Clinici Scientifici Maugeri SpA trials in Italy

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