A Phase 3 interventional study of Nutrition + exercise in Left Ventricular Assist Device, End-stage Heart Failure and Cardiac Surgery, sponsored by RWTH Aachen University. Status unknown at 5 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-26.
Sponsored by RWTH Aachen University · Phase 3, Interventional, and Treatment
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's planned enrollment of 40 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.
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Exclusion Criteria:
Standard Care as per local guidelines
Oral nutrition support (ONS) and bed-cycling before surgery
Combination Product: Nutrition + exercise
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.
Also known as: bed cycling, ONS
Comparison of adverse events
adverse events between groups related to cycling and nutritional complications
Time frame: up to 2 weeks before surgery
Separation of caloric supplementation
Separation between groups on prescribed caloric targets
Time frame: up to 2 weeks before surgery
Separation of protein supplementation
Separation between groups on prescribed protein targets
Time frame: up to 2 weeks before surgery
Proportion of interventions received as prescribed
Proportion of interventions received as prescribed
Time frame: up to 2 weeks before surgery
Rate of patients recruited per month
Target: 1.5 patients per month
Time frame: up to 18 months
Ratio of control patients received physiotherapy
Ratio of control patients received physiotherapy
Time frame: up to 2 weeks before surgery
Ratio of control patients received nutritional support
Ratio of control patients received nutritional support
Time frame: up to 2 weeks before surgery
mortality rates at day 30
mortality rates at day 30
Time frame: day 30 after randomization
rates of ICU length of stay
rates of ICU length of stay
Time frame: up to 3 months
rates of hospital length of stay
rates of hospital length of stay
Time frame: up to 3 months
Mean duration of mechanical ventilation
Mean duration of mechanical ventilation
Time frame: up to 3 months
Incidence of complications
Incidence of complications
Time frame: up to 3 months
Incidence of infections
Incidence of infections
Time frame: up to 3 months
Change in Mid-arm circumference
baseline values versus follow-up values
Time frame: up to 6 months
Change in Muscle mass - Quadriceps thickness
ultrasound, baseline values versus follow-up values
Time frame: up to 6 months
Change in Muscle mass - Quadriceps cross sectional area
ultrasound, baseline values versus follow-up values
Time frame: up to 6 months
Change in Muscle strength - Handgrip strength
Dynamometry, baseline values versus follow-up values
Time frame: up to 6 months
Change in Muscle strength - Quadriceps strength
Dynamometry, baseline values versus follow-up values
Time frame: 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)
Time frame: up to 6 months
Change in Physical function - 6-Minute Walk Test
baseline values versus follow-up values, 6-minute walking distance
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: up to 6 months
Plan to share: Undecided
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RWTH Aachen University