Sengkang General Hospital
Singapore, 544886
NCT Number: NCT05344313
Aims:
Clinical frailty severely impacts the physical, functional and physiological reserves necessary for the recovery after surgery. Sarcopenia, a multifactorial, multi-organ process which lead to loss of muscle mass over time, eventually resulting in clinical frailty. These 2 entities result in an increased morbidity and mortality from surgery. They also lead to a slower recovery from surgery with some patients never reaching baseline function after their surgery. It is, therefore, important to optimize patients with sarcopenia prior to surgery to reduce the incidence of morbidity and mortality.
Nutrition and resistance training have been shown to be able to curb the effects of sarcopenia. However, the type and regime of nutrition is still unknown.
Hypotheses:
The study team hypothesize that Ensure Plus Advance + HMB (beta-hydoxy-beta-methylbutyrate) would reduce the amount of IMAT (inter and intramuscular adipose tissue) in sarocpaenic patients after 2-4 weeks of prehabilitation. This effect would be sustained even after surgery and would continue to improve up to 3-months post-surgery whilst participating in rehabilitation. Taking Ensure Plus Advance + HMB would also improve functional parameters after prehabilitation, ensure a similar QoL 1-month post-surgery even if biochemical parameters may not show a significant improvement.
Methods:
The investigators would be conducting a pilot interventional cohort with an institution with an established prehabilitation programme (SKH) to evaluate the effect of the use a high protein, high calorie oral nutritional supplement (ONS) with HMB on muscle quality, using a device with Automated Intelligence (AI), in sarcopenic patients undergoing gastrointestinal surgery. Primary outcomes will be changes in Intermuscular Adipose Tissue (IMAT) while secondary outcomes include changes in functional parameters, quality-of-life (QoL), surgical outcomes and biochemical results.
Looking for future studies?
Notify Me40 year–90 year
All sexes
Interventional
Not applicable
Singapore, 544886
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
as in the arm description of the intervention
Other names: Resistance training+2 months of rehabilitation
Time frame: 1 day before surgery
change of Inter-muscular adipose tissue (%) between baseline and 1 day before surgery
Time frame: 1 day before surgery
Change of handgrip strength after the prehabilitation programme
Time frame: 1 day before surgery
Change of gait speed after the prehabilitation programme
Time frame: up to 30 days post surgery
change in average length of hospitalization
Time frame: 3 months post surgery
change of Inter-muscular adipose tissue (%) from pre-surgery to 3-months post-surgery
Time frame: 1,2 and 3 months post surgery
change in quality of life measure (EuroQol-5D) at 1-, 2- and 3-months post-surgery
Sengkang General Hospital
Other
Oral Nutritional Supplementation With HMB Enhance Muscle Quality in Sarcopenic Surgical Patients (HEROS) - a Pilot Interventional Cohort Study
Acronym: HEROS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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