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The Impact of Prehabilitation Bundle on Perioperative Outcome for Frail Elderly Patients Undergoing Major Abdominal Surgery

A Randomized Control Trial on the Impact of Prehabilitation Bundle on Perioperative Outcome for Frail Elderly Patients Undergoing Major Abdominal Surgery

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02921932
Enrollment
62
Registered
2016-10-03
Start date
2017-03-01
Completion date
2018-07-31
Last updated
2017-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complication, Postoperative, Perioperative/Postoperative Complications

Keywords

Physiotherapy, Inspiratory Muscle Training, Perioperative Medicine, Postoperative outcomes, Preoperative nutrition, Elderly, frail

Brief summary

This study aims 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. There will be two arms, intervention and control.

Detailed description

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.

Interventions

DIETARY_SUPPLEMENTEnsure, Resource 2.0 and Glucerna

Preoperative nutritional supplement for undernourished patients

OTHERCognitive 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

Sponsors

Singapore General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. Patients attending the Preoperative Evaluation Clinic, SGH at least 11 days prior to his/her elective major abdominal surgery. Major abdominal surgery is defined as an intraperitoneal surgery with expected length of stay beyond 2 days. For patients who attended the clinic more than 11 days prior to surgery date, they will be informed to start their prehabilitation bundle 10 days prior to surgery. 2. Aged 65 and above 3. Diagnosed as frail based on Fried criteria score 3and above 4. Able to understand and follow the prescribed cognitive and physical exercise

Exclusion criteria

1. Patients with Parkinson disease, previous stroke, neuromuscular disorders and those taking carbidopa/levodopa, donepezil hydrochloride or antidepressants as previous studies have found that these medications may cause symptoms that are similar with domains of frailty. 2. Patients who are not able to communicate

Design outcomes

Primary

MeasureTime frame
Length of Hospital StayWill be compared between the intervention and control arms for up to 1 year

Secondary

MeasureTime frameDescription
Post operative complicationsDuration of hospital admission for up to 30 daysmortality, Intensive Care Unit (ICU) stay, reintubation and ventilation days in ICU, Acute Myocardial Infarction, new arrhythmia.
Functional Post Operative RecoveryDuration of hospital admission for up to 30 daysPostoperative Quality of Recovery Scale (PQRS) questionnaire at 4 time points (Day of surgery, Postoperative days 1, 3 and 7) throughout their surgical admissions

Countries

Singapore

Contacts

Primary ContactHairil R Abdullah, MBBS
hairil.rizal.abdullah@singhealth.com.sg6562223322

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026