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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02921932 |
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Date of registration:
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28/09/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The Impact of Prehabilitation Bundle on Perioperative Outcome for Frail Elderly Patients Undergoing Major Abdominal Surgery
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Scientific title:
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A Randomized Control Trial on the Impact of Prehabilitation Bundle on Perioperative Outcome for Frail Elderly Patients Undergoing Major Abdominal Surgery |
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Date of first enrolment:
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March 1, 2017 |
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Target sample size:
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62 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02921932 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
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Phase:
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N/A
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Countries of recruitment
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Singapore
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Contacts
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Name:
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Hairil R Abdullah, mbbs |
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Address:
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Telephone:
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Email:
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Affiliation:
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Singapore General Hospital |
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Name:
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Hairil R Abdullah, MBBS |
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Address:
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Telephone:
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6562223322 |
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Email:
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hairil.rizal.abdullah@singhealth.com.sg |
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Affiliation:
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Name:
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Brenda PY Tan, BSc |
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Address:
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Telephone:
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Email:
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brenda.tan.p.y@sgh.com.sg |
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Affiliation:
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Key inclusion & exclusion 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
Age minimum:
65 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Perioperative/Postoperative Complications
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Complication, Postoperative
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Intervention(s)
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Dietary Supplement: Ensure, Resource 2.0 and Glucerna
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Other: Cognitive Training, Memory Card Game
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Device: 'Threshold' Inspiratory Muscle Trainer, Respironics of New Jersey Inc
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Primary Outcome(s)
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Length of Hospital Stay
[Time Frame: Will be compared between the intervention and control arms for up to 1 year]
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Secondary Outcome(s)
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Functional Post Operative Recovery
[Time Frame: Duration of hospital admission for up to 30 days]
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Post operative complications
[Time Frame: Duration of hospital admission for up to 30 days]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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