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

NCT02921932 | Unknown DMC

• 1 other identifier: 2016/2
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Complication, Postoperative; Perioperative/Postoperative Complications

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Length of Hospital Stay

  Will be compared between the intervention and control arms for up to 1 year

Secondary Outcomes (2)

• Post operative complications

  Duration of hospital admission for up to 30 days

• Functional Post Operative Recovery

  Duration of hospital admission for up to 30 days

Study Arms (2)

Intervention

ACTIVE COMPARATOR

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.

Dietary Supplement: Ensure, Resource 2.0 and Glucerna; Other: Cognitive Training, Memory Card Game; Device: 'Threshold' Inspiratory Muscle Trainer, Respironics of New Jersey Inc

Control

NO INTERVENTION

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.

Interventions

Ensure, Resource 2.0 and Glucerna DIETARY_SUPPLEMENT

Preoperative nutritional supplement for undernourished patients

Intervention

Cognitive Training, Memory Card Game OTHER

Preoperative memory card game

Intervention

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

Inspiratory muscle trainer protocol for strengthening respiratory muscles

Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (1)

Singapore General Hospital

Singapore, 169608, Singapore

RECRUITING

Related Publications (1)

• 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.

  PMID: 28778994 DERIVED

MeSH Terms

Conditions

Postoperative Complications

Interventions

Glucerna; Cognitive Training

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Hairil R Abdullah, mbbs

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hairil R Abdullah, MBBS

CONTACT

6562223322; hairil.rizal.abdullah@singhealth.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2016
• First Posted: October 3, 2016
• Study Start: March 1, 2017
• Primary Completion: March 1, 2018
• Study Completion: July 1, 2018
• Last Updated: October 6, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)