Heart disease in an aging population has resulted in heart surgery being offered to older and more frail patients. Frail patients which make up more than 50% of patients currently undergoing heart surgery are vulnerable to having long-recovery times after surgery, greater loss of independence (i.e. being admitted to a nursing home), experience more depression and anxiety, and have a worse quality of life. In fact, nearly 10% of frail, older adult patients die within 30 days after their heart surgery. The Investigators previous study found that weight-loss and poor muscle strength (i.e. weakness) of frail patients can lead to a worse recovery after heart surgery. Furthermore, inadequate nutrition (aka. malnutrition which is defined as an unintentional, nutritional intake imbalance (not necessarily a decreased intake) before an operation can lead to a vicious cycle of muscle loss causing more frailty, a desire to eat less leading to more muscle loss and increased frailty. At present there is no process to address this important issue in older adults undergoing heart surgery. The Investigators propose to study a practical, real-world, treatment plan that focuses on good nutrition to prevent muscle loss and reduced frailty in vulnerable heart surgery patients.
To enhance recovery in vulnerable older adults (aged 60 years or older) undergoing major heart surgery. The Investigators seek to reduce the stress of heart surgery on the body by providing muscle-building nutrition supplements (with leucine-rich proteins) at key time-points during the patients' journey. Objectives of this study: 1. Will leucine-rich protein nutrition supplementation (given in a liquid form like a protein shake) can reduce functional decline in frail older patients undergoing major heart surgery. The Investigators predict that these supplements will lead to a reduction in functional muscle loss (for example how quickly some can walk) and quicker recovery both in hospital and after going home. 2. Will leucine-rich protein nutrition supplementation will enhance health-related quality of life of frail older adult patients after heart surgery. The Investigators predict that patients will be able to return to activities that they enjoy more quickly and experience less depression and anxiety. In a two-centre clinical trial, frail older adults (patients who are at risk of a long recovery) undergoing major heart surgeries will receive nutrition supplements up to 2 weeks prior to surgery, during post-op recovery in hospital, and for the 8 weeks following hospital discharge. Prior to surgery, all patient in the study will consume a carbohydrate supplement in order to help with nausea symptoms post surgery, glycemic control and GI function. The Investigators will ask 150 (pre)frail patients before their heart surgery to participate. Patient who are 60 years of age or older who agree to be in the study will be randomly selected (75 patients in each group) to receive the nutrition protein shakes or a placebo (a shake without the special protein). In addition to how long a patient needs to stay in hospital after their heart surgery, The Investigators will measure levels of frailty (by different tests of muscle strength), overall nutrition, health related quality of life after surgery as well as mood and anxiety at 2 and 6 months after hospital discharge.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
150
EXPERIMENTAL ARM: Protein supplement to be re-constituted and consumed twice daily for a minimum of 2 weeks pre-procedure, twice daily during post-operative recovery and 2 times daily for 8 weeks after the patient is discharged home.
PLACEBO COMPARATOR ARM: Placebo supplement to be re-constituted and consumed twice daily for a minimum of 2 weeks pre-procedure, twice daily during post-operative recovery and 2 times daily for 8 weeks after the patient is discharged home
St. Boniface General Hospital
Winnipeg, Manitoba, Canada
RECRUITINGJewish General Hospital
Montreal, Quebec, Canada
NOT_YET_RECRUITINGChange in Short-Form 36 physical Function (PF) score
The SF-36 PF assessment captures the physical functioning of participants. It has been moderately correlated with the SPPB and can be used interchangeably if the SPPB is not able to be completed by a patient
Time frame: Assessed at: baseline, Day of Discharge from Hospital after cardiac surgery, 2 months post surgery and 6 months post surgery
health-related QOL measured by the EQ-5D-3L
The EQ-5D-3L measure health related quality of life in our patient cohort
Time frame: Assessed at: baseline, 2 months post surgery and 6 months post surgery
health-related QOL measured by the EQ-VAS
EQ-VAS measure health related quality of life in our patient cohort
Time frame: Assessed at: baseline, 2 months post surgery and 6 months post surgery
Depression
measured by the patient health questionnaire (PHQ-9) this assessment measures the symptoms related to depression
Time frame: Assessed at: baseline, 2 months post surgery and 6 months post surgery
Anxiety
measured by the cardiac anxiety questionnaire (CAQ) this assessment measures the anxiety experienced by patients with cardiovascular disease
Time frame: Assessed at: baseline, 2 months post surgery and 6 months post surgery
Nutrition assessment
Nutrition is measured by the mini nutritional assessment tool
Time frame: Assessed at: baseline, Day of Discharge from Hospital after cardiac surgery, 2 months post surgery and 6 months post surgery
Physical Activity Accumulation
This is measured with the use of physical activity monitors call accelerometers. This will be worn for a period of 7 days after each research appointment
Time frame: Assessed at: baseline, 2 months post surgery and 6 months post surgery
Composite safety endpoint of all-cause mortality, injurious fall, acute kidney injury, or readmission for related events
These parameters will be taken from medical chart reviews post cardiac surgery
Time frame: Parameters collected at the 2 month time point
Health related QOL as measured by OARS - ADL Scale
This scale measures activities of daily living
Time frame: Assessed at: baseline, 2 months post surgery and 6 months post surgery
Nausea and vomiting questionnaire
This scale measures symptoms of nausea and vomiting while a patient is recovering in-hospital following cardiac surgery
Time frame: Assessed (only 1 time point) while patient is in-hospital recovering from cardiac surgery. (i.e. 6 days after cardiac surgery)
Frailty
This measure will be assessed using the Modified Fried Criteria. this includes measures such as: Hand grip strength, exhaustion, nutrition, and physical activity accumulation. This assessment will return a value from 0-5 identifying the frailty of the patient at each of the time points identified
Time frame: Assessed at: baseline, 2 months post-surgery and 6 months post-surgery
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