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

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ClinicalTrials.gov Identifier: NCT02921932
Recruitment Status : Recruiting
First Posted : October 3, 2016
Last Update Posted : October 6, 2017
Sponsor:
Information provided by (Responsible Party):
Singapore General Hospital

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.

Condition or disease Intervention/treatment Phase
Complication, Postoperative Perioperative/Postoperative Complications Dietary Supplement: Ensure, Resource 2.0 and Glucerna Other: Cognitive Training, Memory Card Game Device: 'Threshold' Inspiratory Muscle Trainer, Respironics of New Jersey Inc Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized Control Trial on the Impact of Prehabilitation Bundle on Perioperative Outcome for Frail Elderly Patients Undergoing Major Abdominal Surgery
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery

Arm Intervention/treatment
Active Comparator: 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.

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

No Intervention: 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.



Primary Outcome Measures :
  1. Length of Hospital Stay [ Time Frame: Will be compared between the intervention and control arms for up to 1 year ]

Secondary Outcome Measures :
  1. Post operative complications [ Time Frame: Duration of hospital admission for up to 30 days ]
    mortality, Intensive Care Unit (ICU) stay, reintubation and ventilation days in ICU, Acute Myocardial Infarction, new arrhythmia.

  2. Functional Post Operative Recovery [ Time Frame: Duration of hospital admission for up to 30 days ]
    Postoperative Quality of Recovery Scale (PQRS) questionnaire at 4 time points (Day of surgery, Postoperative days 1, 3 and 7) throughout their surgical admissions



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02921932


Contacts
Contact: Hairil R Abdullah, MBBS 6562223322 hairil.rizal.abdullah@singhealth.com.sg

Locations
Singapore
Singapore General Hospital Recruiting
Singapore, Singapore, 169608
Contact: Brenda PY Tan, BSc       brenda.tan.p.y@sgh.com.sg   
Principal Investigator: Hairil Rizal Abdullah, MBBS         
Sub-Investigator: Shariq Ali Khan, MD         
Sub-Investigator: Victoria Lien, MBBS         
Sub-Investigator: Hwee Kuan Ong, PHd         
Sponsors and Collaborators
Singapore General Hospital
Investigators
Principal Investigator: Hairil R Abdullah, mbbs Singapore General Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Singapore General Hospital
ClinicalTrials.gov Identifier: NCT02921932     History of Changes
Other Study ID Numbers: 2016/2
First Posted: October 3, 2016    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Singapore General Hospital:
Physiotherapy
Inspiratory Muscle Training
Perioperative Medicine
Postoperative outcomes
Preoperative nutrition
Elderly, frail

Additional relevant MeSH terms:
Postoperative Complications
Pathologic Processes