The Impact of Prehabilitation Bundle on Perioperative Outcome for Frail Elderly Patients Undergoing Major Abdominal Surgery
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|ClinicalTrials.gov Identifier: NCT02921932|
Recruitment Status : Recruiting
First Posted : October 3, 2016
Last Update Posted : October 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Complication, Postoperative Perioperative/Postoperative Complications||Dietary Supplement: Ensure, Resource 2.0 and Glucerna Other: Cognitive Training, Memory Card Game Device: 'Threshold' Inspiratory Muscle Trainer, Respironics of New Jersey Inc||Not Applicable|
Frailty is a geriatric syndrome, defined as an increased vulnerability to stressors leading to a state of decreased physiological resistance. It is characterised by a "constellation of symptoms and signs that describe the heterogeneous response of older adults to physiological and metabolic challenges." While frailty is not necessarily synonymous with chronological age, it is more prevalent among the older adult population and is associated with up to a threefold increased risk of mortality or major morbidity postsurgery. Thus, it has become critically important for healthcare systems to develop strategies designed to improve clinical outcomes in this high-risk population when undergoing surgeries.
Currently there is no clear intervention that has been proven to modify the syndrome of frailty or its impact on postoperative outcomes. This study investigates a novel multidisciplinary approach that can be implemented within a short time frame prior to surgery.
We plan to study the efficacy of a preoperative "bundle" of interventions, which consists of preoperative physiotherapy, nutritional support and cognitive exercises on elderly frail patients undergoing major abdominal surgery, and evaluating their outcomes based 1) length of hospital stay 2) Functional recovery from surgery 3) post-operative complications.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||62 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized Control Trial on the Impact of Prehabilitation Bundle on Perioperative Outcome for Frail Elderly Patients Undergoing Major Abdominal Surgery|
|Actual Study Start Date :||March 1, 2017|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||July 2018|
Active Comparator: Intervention
In the interventional arm, patients will be given:
Patients will be provided with a protocol activities log and a study assistant will be conducting a telephone conversation on day 1, 4 and 7 to encourage compliance to the protocol and answer any queries with regards to the research study.
Dietary Supplement: Ensure, Resource 2.0 and Glucerna
Preoperative nutritional supplement for undernourished patients
Other: Cognitive Training, Memory Card Game
Preoperative memory card game
Device: 'Threshold' Inspiratory Muscle Trainer, Respironics of New Jersey Inc
Inspiratory muscle trainer protocol for strengthening respiratory muscles
No Intervention: Control
In the control arm, patients will be given the standard education materials regarding surgery and carry out daily activities as usual until the admission of the surgery.
- Length of Hospital Stay [ Time Frame: Will be compared between the intervention and control arms for up to 1 year ]
- Post operative complications [ Time Frame: Duration of hospital admission for up to 30 days ]mortality, Intensive Care Unit (ICU) stay, reintubation and ventilation days in ICU, Acute Myocardial Infarction, new arrhythmia.
- Functional Post Operative Recovery [ Time Frame: Duration of hospital admission for up to 30 days ]Postoperative Quality of Recovery Scale (PQRS) questionnaire at 4 time points (Day of surgery, Postoperative days 1, 3 and 7) throughout their surgical admissions
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02921932
|Contact: Hairil R Abdullah, MBBSfirstname.lastname@example.org|
|Singapore General Hospital||Recruiting|
|Singapore, Singapore, 169608|
|Contact: Brenda PY Tan, BSc email@example.com|
|Principal Investigator: Hairil Rizal Abdullah, MBBS|
|Sub-Investigator: Shariq Ali Khan, MD|
|Sub-Investigator: Victoria Lien, MBBS|
|Sub-Investigator: Hwee Kuan Ong, PHd|
|Principal Investigator:||Hairil R Abdullah, mbbs||Singapore General Hospital|