Complication, PostoperativeNCT02921932
The Impact of Prehabilitation Bundle on Perioperative Outcome for Frail Elderly Patients Undergoing Major Abdominal Surgery
A study testing Ensure, Resource 2.0 and Glucerna, Cognitive Training, Memory Card Game and 'Threshold' Inspiratory Muscle Trainer, Respironics of New Jersey Inc in people with Complication, Postoperative and Perioperative/Postoperative Complications, run by Singapore General Hospital at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Complication, Postoperative, Perioperative/Postoperative Complications
- What is being tested?
- Ensure, Resource 2.0 and Glucerna, Cognitive Training, Memory Card Game and 'Threshold' Inspiratory Muscle Trainer, Respironics of New Jersey Inc
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Mar 2017to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Singapore General Hospital
Singapore, 169608
Brenda PY Tan, BSc, brenda.tan.p.y@sgh.com.sg
Hairil Rizal Abdullah, MBBS
About this study
Official title: A Randomized Control Trial on the Impact of Prehabilitation Bundle on Perioperative Outcome for Frail Elderly Patients Undergoing Major Abdominal Surgery
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.
Read the 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.
- Being tested
- Ensure, Resource 2.0 and Glucerna, Cognitive Training, Memory Card Game, 'Threshold' Inspiratory Muscle Trainer, Respironics of New Jersey Inc
- Keywords
- Physiotherapy, Inspiratory Muscle Training, Perioperative Medicine, Postoperative outcomes, Preoperative nutrition, Elderly, frail
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ensure, Resource 2.0 and GlucernaDietary supplement
Preoperative nutritional supplement for undernourished patients
Cognitive Training, Memory Card GameOther
Preoperative memory card game
'Threshold' Inspiratory Muscle Trainer, Respironics of New Jersey IncDevice
Inspiratory muscle trainer protocol for strengthening respiratory muscles
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Hospital Stay
Measured: Will be compared between the intervention and control arms for up to 1 year
Secondary outcomes (2)
Post operative complications
mortality, Intensive Care Unit (ICU) stay, reintubation and ventilation days in ICU, Acute Myocardial Infarction, new arrhythmia.
Measured: Duration of hospital admission for up to 30 days
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
Measured: Duration of hospital admission for up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2016 (estimated)
- Study start1 Mar 2017
- Primary completionMar 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Complication, PostoperativeStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hairil R Abdullah, mbbs, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02921932
- Sponsor's protocol ID
- 2016/2
- Status last verified
- Oct 2017
- First submitted
- 28 Sep 2016
- Last updated
- 6 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28778994
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial on the Impact of Prehabilitation Bundle on Perioperative Outcome for Frail Elderly Patients Undergoing Major Abdominal Surgery
- ClinicalTrials.gov ID
- NCT02921932
- Acronym / sponsor ID
- 2016/2
- Keywords
- Physiotherapy, Inspiratory Muscle Training, Perioperative Medicine, Postoperative outcomes, Preoperative nutrition, Elderly, frail
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 3 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Dietary Supplement: Ensure, Resource 2.0 and Glucerna, Other: Cognitive Training, Memory Card Game, Device: 'Threshold' Inspiratory Muscle Trainer, Respironics of New Jersey IncIn 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. |
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ensure, Resource 2.0 and GlucernaPreoperative nutritional supplement for undernourished patients | Dietary supplement | Intervention |
| Cognitive Training, Memory Card GamePreoperative memory card game | Other | Intervention |
| 'Threshold' Inspiratory Muscle Trainer, Respironics of New Jersey IncInspiratory muscle trainer protocol for strengthening respiratory muscles | Device | Intervention |
Primary outcome
Length of Hospital Stay
Time frame: Will be compared between the intervention and control arms for up to 1 year
2 secondary outcomes
Post operative complications
Time frame: Duration of hospital admission for up to 30 days
Functional Post Operative Recovery
Time frame: Duration of hospital admission for up to 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
- Derived from this study: PubMed 28778994Abdullah 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hairil R Abdullah, mbbs principal investigator
Singapore General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ensure, Resource 2.0 and Glucerna, Cognitive Training, Memory Card Game and 'Threshold' Inspiratory Muscle Trainer, Respironics of New Jersey Inc in people with Complication, Postoperative and Perioperative/Postoperative Complications, run by Singapore General Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hairil R Abdullah, MBBS (6562223322, hairil.rizal.abdullah@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Hospital Stay (time frame: Will be compared between the intervention and control arms for up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02921932, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2017.