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This is a pilot, randomized, multicenter interventional trial of a combined preoperative oral nutritional support (ONS) and physical exercise therapy in patients planned for elective implantation of a left-ventricular assist device (LVAD). This pilot study pursues to demonstrate the feasibility and safety of a study protocol to optimize the patients' nutritional and physical state to reduce the number of postoperative complications and consequently to ameliorate the patients' outcome.
The oral nutrition supplementation will be started immediately after randomization and will be continued until surgery. The patients will receive a dosage of ONS adjusted to their nutritional risk. Regular monitoring of blood sugars, electrolytes, phosphate, and triglycerides will occur twice per week, as per standard protocol.
In-bed cycling will be started as soon as possible after randomization. Cycling sessions will be performed daily for 50 minutes, at least 5 times a week until surgery. Standard safety criteria will be assessed prior to initiating cycling treatments. The in-bed cycling will be performed passively or actively with graded increasing resistance. All cycling interventions will be performed under 1:1 supervision of medically trained study personnel while monitoring patient's heart rate, systolic and diastolic blood pressure and transcutaneous oxygen saturation of blood.
When evaluating the effect of a combined nutritional and exercise intervention, other important co-interventions should be standardized to reduce potential confounding of trial outcomes. All study patients should be fed with an oral diet that is in accordance to local standards, whereas it is strongly recommended to adhere to current clinical practice guidelines. Besides, the investigators highly encourage daily respiratory therapy in both groups plus mobilization as much as feasible.
All other key interventions during preoperative treatment will be standardized in accordance to the local clinical practice. Study teams will follow up on the patients on a daily base, documenting adherence with study interventions and key co-interventions.
Patients in the control group will not receive preoperative ONS. No bed cycling will be allowed from admission until surgery. Neither of these practices are the current standard of care in the participating unit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | Standard Care as per local guidelines | |
| Intervention | Experimental | Oral nutrition support (ONS) and bed-cycling before surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutrition + exercise | Combination Product | Patients will receive preoperative optimization consisting of oral nutrition support (Fresubin 3.2 kcal) and bed-cycling (50 minutes per day) for 5-14 days before surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of adverse events | adverse events between groups related to cycling and nutritional complications | up to 2 weeks before surgery |
| Separation of caloric supplementation | Separation between groups on prescribed caloric targets | up to 2 weeks before surgery |
| Separation of protein supplementation | Separation between groups on prescribed protein targets | up to 2 weeks before surgery |
| Proportion of interventions received as prescribed | Proportion of interventions received as prescribed | up to 2 weeks before surgery |
| Rate of patients recruited per month | Target: 1.5 patients per month | up to 18 months |
| Ratio of control patients received physiotherapy | Ratio of control patients received physiotherapy | up to 2 weeks before surgery |
| Ratio of control patients received nutritional support | Ratio of control patients received nutritional support | up to 2 weeks before surgery |
| Measure | Description | Time Frame |
|---|---|---|
| mortality rates at day 30 | mortality rates at day 30 | day 30 after randomization |
| rates of ICU length of stay | rates of ICU length of stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aileen Hill, Dr. med. | Contact | +49 241 80 | 38166 | ahill@ukaachen.de |
| Elena Laaf, MSc | Contact | +49 241 80 | 89021 | elaaf@ukaachen.de |
| Name | Affiliation | Role |
|---|---|---|
| Christian Stoppe, Prof. Dr. med. | RWTH Aachen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart Center Bad Oeynhausen | Recruiting | Bad Oeynhausen | North Rhine-Westphalia | Germany |
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National multicenter two-group randomized-controlled, blinded to assessor clinical pilot trial
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functional outcome assessor will be blinded to study group allocation
|
| up to 3 months |
| rates of hospital length of stay | rates of hospital length of stay | up to 3 months |
| Mean duration of mechanical ventilation | Mean duration of mechanical ventilation | up to 3 months |
| Incidence of complications | Incidence of complications | up to 3 months |
| Incidence of infections | Incidence of infections | up to 3 months |
| Change in Mid-arm circumference | baseline values versus follow-up values | up to 6 months |
| Change in Muscle mass - Quadriceps thickness | ultrasound, baseline values versus follow-up values | up to 6 months |
| Change in Muscle mass - Quadriceps cross sectional area | ultrasound, baseline values versus follow-up values | up to 6 months |
| Change in Muscle strength - Handgrip strength | Dynamometry, baseline values versus follow-up values | up to 6 months |
| Change in Muscle strength - Quadriceps strength | Dynamometry, baseline values versus follow-up values | up to 6 months |
| Change of Clinical Frailty score (CFS) | baseline values versus follow-up values; Score: 1-9 (very fit: 1, terminally ill: 9) | up to 6 months |
| Change in Physical function - 6-Minute Walk Test | baseline values versus follow-up values, 6-minute walking distance | up to 6 months |
| Change in Physical function - Short Physical Performance Battery | baseline values versus follow-up values,(Score: 0-12; 0=worst performance and 12=best performance) | up to 6 months |
| Change in Physical function - Functional Status Score for the ICU | baseline values versus follow-up values,(Score 0-35; the higher the score, the better physical functioning) | up to 6 months |
| Change in quality of life - Lawton Instrumental Activities of Daily Living (IADL) | baseline values versus follow-up values, (score 0-8; the higher the more independent) | up to 6 months |
| Change in quality of life - Katz Activities of Daily Living (ADL) | baseline values versus follow-up values,(Score: 0-100; the higher the more independent) | up to 6 months |
| Quality of life - Short Form 36 (SF-36) | baseline values versus follow-up values,(Score: 0-100; 100=no limitation in daily life and 0=completely limited) | up to 6 months |
| Change in neurological function - Mini Mental State Examination | baseline values versus follow-up values, (score: 0-30; the higher the less cognitively impaired) | up to 6 months |
| RWTH Aachen University | Recruiting | Aachen | Germany |
|
| Heart Center Dresden | Not yet recruiting | Dresden | Germany |
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| University Hospital Justus-Liebig University Giessen | Not yet recruiting | Giessen | Germany |
|
| University Medical Center Schleswig-Holstein, Campus Kiel | Not yet recruiting | Kiel | Germany |
|
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D009752 | Nutritional Status |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D006304 | Health Status |
| D003710 | Demography |
| D011154 | Population Characteristics |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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