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

Primary Purpose

Complication, Postoperative, Perioperative/Postoperative Complications

Status
Unknown status
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Ensure, Resource 2.0 and Glucerna
Cognitive Training, Memory Card Game
'Threshold' Inspiratory Muscle Trainer, Respironics of New Jersey Inc
Sponsored by
Singapore General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complication, Postoperative focused on measuring Physiotherapy, Inspiratory Muscle Training, Perioperative Medicine, Postoperative outcomes, Preoperative nutrition, Elderly, frail

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Singapore General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention

Control

Arm Description

In the interventional arm, patients will be given: A 'Threshold' Inspiratory Muscle Trainer A nutritional assessment: if needed, dietary supplements prescribed (i.e Ensure, Glucerna). Cognitive exercise in the form of the 'Memory' card game will be taught to the patients and the caregiver (if available), to be done twice a day. 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.

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.

Outcomes

Primary Outcome Measures

Length of Hospital Stay

Secondary Outcome Measures

Post operative complications
mortality, Intensive Care Unit (ICU) stay, reintubation and ventilation days in ICU, Acute Myocardial Infarction, new arrhythmia.
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

Full Information

First Posted
September 28, 2016
Last Updated
October 5, 2017
Sponsor
Singapore General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02921932
Brief Title
The Impact of Prehabilitation Bundle on Perioperative Outcome for Frail Elderly Patients Undergoing Major Abdominal Surgery
Official Title
A Randomized Control Trial on the Impact of Prehabilitation Bundle on Perioperative Outcome for Frail Elderly Patients Undergoing Major Abdominal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
July 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Singapore General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complication, Postoperative, Perioperative/Postoperative Complications
Keywords
Physiotherapy, Inspiratory Muscle Training, Perioperative Medicine, Postoperative outcomes, Preoperative nutrition, Elderly, frail

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
In the interventional arm, patients will be given: A 'Threshold' Inspiratory Muscle Trainer A nutritional assessment: if needed, dietary supplements prescribed (i.e Ensure, Glucerna). Cognitive exercise in the form of the 'Memory' card game will be taught to the patients and the caregiver (if available), to be done twice a day. 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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Ensure, Resource 2.0 and Glucerna
Intervention Description
Preoperative nutritional supplement for undernourished patients
Intervention Type
Other
Intervention Name(s)
Cognitive Training, Memory Card Game
Intervention Description
Preoperative memory card game
Intervention Type
Device
Intervention Name(s)
'Threshold' Inspiratory Muscle Trainer, Respironics of New Jersey Inc
Intervention Description
Inspiratory muscle trainer protocol for strengthening respiratory muscles
Primary Outcome Measure Information:
Title
Length of Hospital Stay
Time Frame
Will be compared between the intervention and control arms for up to 1 year
Secondary Outcome Measure Information:
Title
Post operative complications
Description
mortality, Intensive Care Unit (ICU) stay, reintubation and ventilation days in ICU, Acute Myocardial Infarction, new arrhythmia.
Time Frame
Duration of hospital admission for up to 30 days
Title
Functional Post Operative Recovery
Description
Postoperative Quality of Recovery Scale (PQRS) questionnaire at 4 time points (Day of surgery, Postoperative days 1, 3 and 7) throughout their surgical admissions
Time Frame
Duration of hospital admission for up to 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Aged 65 and above Diagnosed as frail based on Fried criteria score 3and above Able to understand and follow the prescribed cognitive and physical exercise Exclusion Criteria: 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. Patients who are not able to communicate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hairil R Abdullah, MBBS
Phone
6562223322
Email
hairil.rizal.abdullah@singhealth.com.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hairil R Abdullah, mbbs
Organizational Affiliation
Singapore General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brenda PY Tan, BSc
Email
brenda.tan.p.y@sgh.com.sg
First Name & Middle Initial & Last Name & Degree
Hairil Rizal Abdullah, MBBS
First Name & Middle Initial & Last Name & Degree
Shariq Ali Khan, MD
First Name & Middle Initial & Last Name & Degree
Victoria Lien, MBBS
First Name & Middle Initial & Last Name & Degree
Hwee Kuan Ong, PHd

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28778994
Citation
Abdullah HR, Lien VP, Ong HK, Er PL, Hao Y, Khan SA, Liu CW. Protocol for a single-centre, randomised controlled study of a preoperative rehabilitation bundle in the frail and elderly undergoing abdominal surgery. BMJ Open. 2017 Aug 4;7(8):e016815. doi: 10.1136/bmjopen-2017-016815.
Results Reference
derived

Learn more about this trial

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

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