Surgery ComplicationsNCT07655414
The ACCELERATE Pilot Trial
A study testing Cognitive Prehabilitation in people with Surgery Complications, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
The Advancing Cognition and Cognitive reserve before ELective surgery to Enhance cognitive Recovery And TrajEctories (ACCELERATE) Pilot Trial estimates whether our novel, coach-supported cognitive prehabilitation strategy will achieve adequate intervention adherence in the context of a feasible multicenter trial… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Surgery Complications
- What is being tested?
- Cognitive Prehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2026to Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >/= 60 years
- Planned, inpatient, surgical procedures: abdominal, orthopedic, spine, thoracic, pelvic, ENT, and vascular
- Clinical Frailty Scale (CFS) score >/= 4
- Expected time to surgery >/= 4 weeks
- Cognitive capacity to independently consent for surgery
Who cannot join
- Cardiac and intracranial neurosurgery procedures
- Visual impairment
- Lack of English fluency
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Emily Hladkowicz, PhD, 613-798-5555 ext. 18629, emhladkowicz@toh.ca
Leandra Amado, MD
About this study
Official title: Advancing Cognition and Cognitive Reserve Before ELective Surgery to Enhance Cognitive Recovery And TrajEctories (ACCELERATE)Trial: a Pilot Multicenter Randomized Trial
The Advancing Cognition and Cognitive reserve before ELective surgery to Enhance cognitive Recovery And TrajEctories (ACCELERATE) Pilot Trial estimates whether our novel, coach-supported cognitive prehabilitation strategy will achieve adequate intervention adherence in the context of a feasible multicenter trial protocol.
Read the detailed description
Background: Delirium, a fluctuating, acute disturbance in attention and awareness, develops in 15-50% of older adults after major surgery. Promising, early stage evidence suggests that cognitive prehabilitation could decrease the absolute risk of postoperative delirium by 10% or more. However, multicenter trials that feasibly optimize cognitive prehabilitation adherence amongst populations most likely to benefit from the intervention are required to advance cognitive prehabilitation toward routine practice.
Overarching Aim: The ACCELERATE Pilot Trial will estimate whether our novel, coach-supported cognitive prehabilitation strategy will achieve adequate intervention adherence in the context of a feasible multicenter trial protocol.
Methods:
Design, setting and participants: The ACCELERATE Pilot trial is prospective single-arm interventional pilot trial.
People >/= 60 years old with Clinical Frailty Scale (CFS) score >/= 4 having inpatient abdominal, orthopedic, spine, thoracic, pelvic, head-and-neck, and vascular surgery with expected time to surgery >/= 4 weeks will be included.
Intervention: Our intervention is a home-based, online, adaptive, multidomain cognitive prehabilitation program, using a cognitive training platform (Lumosity [Lumos Labs]), enhanced by theory- and evidence-informed structured coaching.
Outcomes and sample size: Primary outcome is intervention adherence. Secondary outcomes are monthly recruitment and fidelity to delirium assessment. Our pilot sample size of n=103 is designed to provide 80% power at a 5% level of significance to test whether the proportion of adherent patients exceeds our feasibility target of 75%.
Expertise: Our team features multidisciplinary clinical and methodological experts, nationally representative knowledge users and patient representatives.
Expected outcomes: The ACCELERATE Pilot Trial will derive robust estimates of intervention adherence when supported by structured coaching, as well as trial protocol feasibility. If the pilot trial is feasible, we will proceed with the full ACCELERATE Trial, which will be powered to estimate the effectiveness of cognitive prehabilitation in reducing delirium along with partner-prioritized secondary outcomes.
- Conditions
- Surgery Complications
- Being tested
- Cognitive Prehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive PrehabilitationBehavioural
home-based, online, adaptive, multidomain cognitive prehabilitation program, using a cognitive training platform (Lumosity [Lumos Labs]), enhanced by theory- and evidence-informed structured coaching.
| Study group | Role | What they receive |
|---|---|---|
| Intervention (cognitive prehabilitation) | Experimental | Home-based, online, adaptive, multidomain cognitive prehabilitation program, using a cognitive training platform (Lumosity [Lumos Labs]), enhanced by theory- and evidence-informed structured coaching. Receives: Behavioral: Cognitive Prehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention adherence
≥75% of intervention participants completing >/=10 hrs of cognitive prehabilitation
Measured: From baseline until surgery; intervention duration varies by participant and continues through the preoperative period (minimum of 4 weeks pre-surgery)
Secondary outcomes (2)
Monthly recruitment
≥4 participants per center per month (a 40% recruitment rate; full trial would require 36 months to complete)
Measured: 1 month
Primary outcome ascertainment
≥ 90% of participants with ≥ 6 complete in-hospital delirium assessments
Measured: Delirium will be assessed at the following timepoints after surgery: 1 hour after emergence, and twice daily on postop days 1, 2 and 3 at 08:00 and 20:00; 7 total
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery ComplicationsStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 103 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Anesthesiologists' Society, University of Ottawa Anesthesiology and Pain Medicine
- Responsible party
- Sponsor
- Investigators
- Leandra Amado, MD, Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07655414
- Sponsor's protocol ID
- REB TBD
- Status last verified
- Jul 2026
- First submitted
- 25 May 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data, including data dictionaries, will be available. This includes individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). The Study Protocol, Statistical Analysis Plan and Informed Consent Form will also be made available. Data will be available beginning 3 months and ending 5 years following article publication of one year follow up data. Data will be shared with researchers who provide a methodologically sound proposal. Data can be used to achieve aims in a proposed proposal or for individual participant data meta-analysis. Proposals should be directed to the Principal Investigator. To gain access, data requestors will need to sign a data access agreement. Data will be shared via an appropriate 3rd party website that is consistent with ethical and health privacy compliant legislation at the time of study conclusion.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing Cognition and Cognitive Reserve Before ELective Surgery to Enhance Cognitive Recovery And TrajEctories (ACCELERATE)Trial: a Pilot Multicenter Randomized Trial
- ClinicalTrials.gov ID
- NCT07655414
- Acronym / sponsor ID
- REB TBD
- Conditions
- Surgery Complications
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 103 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Canadian Anesthesiologists' Society, University of Ottawa Anesthesiology and Pain Medicine
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 17 Jun 2026 (actual)
- 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.
The Advancing Cognition and Cognitive reserve before ELective surgery to Enhance cognitive Recovery And TrajEctories (ACCELERATE) Pilot Trial estimates whether our novel, coach-supported cognitive prehabilitation strategy will achieve adequate intervention adherence in the context of a feasible multicenter trial protocol.
Detailed description
Background: Delirium, a fluctuating, acute disturbance in attention and awareness, develops in 15-50% of older adults after major surgery. Promising, early stage evidence suggests that cognitive prehabilitation could decrease the absolute risk of postoperative delirium by 10% or more. However, multicenter trials that feasibly optimize cognitive prehabilitation adherence amongst populations most likely to benefit from the intervention are required to advance cognitive prehabilitation toward routine practice.
Overarching Aim: The ACCELERATE Pilot Trial will estimate whether our novel, coach-supported cognitive prehabilitation strategy will achieve adequate intervention adherence in the context of a feasible multicenter trial protocol.
Methods:
Design, setting and participants: The ACCELERATE Pilot trial is prospective single-arm interventional pilot trial.
People >/= 60 years old with Clinical Frailty Scale (CFS) score >/= 4 having inpatient abdominal, orthopedic, spine, thoracic, pelvic, head-and-neck, and vascular surgery with expected time to surgery >/= 4 weeks will be included.
Intervention: Our intervention is a home-based, online, adaptive, multidomain cognitive prehabilitation program, using a cognitive training platform (Lumosity [Lumos Labs]), enhanced by theory- and evidence-informed structured coaching.
Outcomes and sample size: Primary outcome is intervention adherence. Secondary outcomes are monthly recruitment and fidelity to delirium assessment. Our pilot sample size of n=103 is designed to provide 80% power at a 5% level of significance to test whether the proportion of adherent patients exceeds our feasibility target of 75%.
Expertise: Our team features multidisciplinary clinical and methodological experts, nationally representative knowledge users and patient representatives.
Expected outcomes: The ACCELERATE Pilot Trial will derive robust estimates of intervention adherence when supported by structured coaching, as well as trial protocol feasibility. If the pilot trial is feasible, we will proceed with the full ACCELERATE Trial, which will be powered to estimate the effectiveness of cognitive prehabilitation in reducing delirium along with partner-prioritized secondary outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention (cognitive prehabilitation) | Experimental | Behavioral: Cognitive PrehabilitationHome-based, online, adaptive, multidomain cognitive prehabilitation program, using a cognitive training platform (Lumosity [Lumos Labs]), enhanced by theory- and evidence-informed structured coaching. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age >/= 60 years
- Planned, inpatient, surgical procedures: abdominal, orthopedic, spine, thoracic, pelvic, ENT, and vascular
- Clinical Frailty Scale (CFS) score >/= 4
- Expected time to surgery >/= 4 weeks
- Cognitive capacity to independently consent for surgery
Key exclusion criteria (3 listed)
- Cardiac and intracranial neurosurgery procedures
- Visual impairment
- Lack of English fluency
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 |
|---|---|---|
| Cognitive Prehabilitationhome-based, online, adaptive, multidomain cognitive prehabilitation program, using a cognitive training platform (Lumosity [Lumos Labs]), enhanced by theory- and evidence-informed structured coaching. | Behavioural | Intervention (cognitive prehabilitation) |
Primary outcome
Intervention adherence
Time frame: From baseline until surgery; intervention duration varies by participant and continues through the preoperative period (minimum of 4 weeks pre-surgery)
≥75% of intervention participants completing >/=10 hrs of cognitive prehabilitation
2 secondary outcomes
Monthly recruitment
Time frame: 1 month
Primary outcome ascertainment
Time frame: Delirium will be assessed at the following timepoints after surgery: 1 hour after emergence, and twice daily on postop days 1, 2 and 3 at 08:00 and 20:00; 7 total
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: Yes. Individual participant data, including data dictionaries, will be available. This includes individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). The Study Protocol, Statistical Analysis Plan and Informed Consent Form will also be made available. Data will be available beginning 3 months and ending 5 years following article publication of one year follow up data. Data will be shared with researchers who provide a methodologically sound proposal. Data can be used to achieve aims in a proposed proposal or for individual participant data meta-analysis. Proposals should be directed to the Principal Investigator. To gain access, data requestors will need to sign a data access agreement. Data will be shared via an appropriate 3rd party website that is consistent with ethical and health privacy compliant legislation at the time of study conclusion.
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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.
Leandra Amado, MD principal investigator
The Ottawa 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 Cognitive Prehabilitation in people with Surgery Complications, run by Ottawa Hospital Research Institute at 1 site in Canada.
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 5 inclusion and 3 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: opening soon, as of the sponsor's last update on 7 Jul 2026. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leandra Amado, MD (613-798-5555, lamado@toh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention adherence (time frame: From baseline until surgery; intervention duration varies by participant and continues through the preoperative period (minimum of 4 weeks pre-surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jul 2026.