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

NCT ID: NCT02921932

Last Updated: 2017-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2018-07-31

Brief Summary

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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

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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.

Conditions

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Complication, Postoperative Perioperative/Postoperative Complications

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention

In the interventional arm, patients will be given:

1. A 'Threshold' Inspiratory Muscle Trainer
2. A nutritional assessment: if needed, dietary supplements prescribed (i.e Ensure, Glucerna).
3. 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.

Group Type ACTIVE_COMPARATOR

Ensure, Resource 2.0 and Glucerna

Intervention Type DIETARY_SUPPLEMENT

Preoperative nutritional supplement for undernourished patients

Cognitive Training, Memory Card Game

Intervention Type OTHER

Preoperative memory card game

'Threshold' Inspiratory Muscle Trainer, Respironics of New Jersey Inc

Intervention Type DEVICE

Inspiratory muscle trainer protocol for strengthening respiratory muscles

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ensure, Resource 2.0 and Glucerna

Preoperative nutritional supplement for undernourished patients

Intervention Type DIETARY_SUPPLEMENT

Cognitive Training, Memory Card Game

Preoperative memory card game

Intervention Type OTHER

'Threshold' Inspiratory Muscle Trainer, Respironics of New Jersey Inc

Inspiratory muscle trainer protocol for strengthening respiratory muscles

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Singapore General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hairil R Abdullah, mbbs

Role: PRINCIPAL_INVESTIGATOR

Singapore General Hospital

Locations

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Singapore General Hospital

Singapore, , Singapore

Site Status RECRUITING

Countries

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Singapore

Central Contacts

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Hairil R Abdullah, MBBS

Role: CONTACT

Phone: 6562223322

Email: [email protected]

Facility Contacts

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Brenda PY Tan, BSc

Role: primary

References

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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.

Reference Type DERIVED
PMID: 28778994 (View on PubMed)

Other Identifiers

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2016/2

Identifier Type: -

Identifier Source: org_study_id