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

Perioperative/Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02921932
• Other study ID #: 2016/2
• Status: Recruiting
• Phase: N/A
• First received: September 28, 2016
• Last updated: October 5, 2017
• Start date: March 1, 2017
• Est. completion date: July 2018

Study information

• Verified date: October 2017
• Source: Singapore General Hospital
• Contact: Hairil R Abdullah, MBBS
• Phone: 6562223322
• Email: hairil.rizal.abdullah[@]singhealth.com.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: July 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Complication, Postoperative
• Perioperative/Postoperative Complications
• Postoperative Complications

Intervention

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

Locations

Country	Name	City	State
Singapore	Singapore General Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Singapore General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of Hospital Stay		Will be compared between the intervention and control arms for up to 1 year
Secondary	Post operative complications	mortality, Intensive Care Unit (ICU) stay, reintubation and ventilation days in ICU, Acute Myocardial Infarction, new arrhythmia.	Duration of hospital admission for up to 30 days
Secondary	Functional Post Operative Recovery	Postoperative Quality of Recovery Scale (PQRS) questionnaire at 4 time points (Day of surgery, Postoperative days 1, 3 and 7) throughout their surgical admissions	Duration of hospital admission for up to 30 days