Cognitive ImpairmentNCT03094988
COgnitive and Physical Exercise (COPE) Prehabilitation Pilot Feasibility Study
A study testing Cognitive and physical prehabilitation in people with Cognitive Impairment and Physical Impairment, run by Vanderbilt University at 1 site in United States.
Trial summary
Cognitive and functional impairment are debilitating problems for survivors of major surgery. Efforts to modify medical treatments to prevent such impairment are ongoing and may yet yield significant benefits. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cognitive Impairment, Physical Impairment, Postoperative Complications
- What is being tested?
- Cognitive and physical prehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2017to 1 Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults undergoing major surgery with the likelihood of prolonged hospitalization or critical illness among the following surgical services: general surgery, surgical oncology, otolaryngology, hepatobiliary, thoracic, and vascular surgery
Who cannot join
- Blind, deaf, or unable to speak English, as these conditions would preclude our ability to perform the proposed cognitive and physical program
- Pregnancy
- Prisoners
- Severe frailty or physical impairment that prohibits participation in prehabilitation program
- Patients with documented dementia or cognitive impairment that precludes ability to self-consent for surgery and study participation
- Less than 2 weeks from scheduled surgery
- Patients without home internet access
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
About this study
Official title: COgnitive and Physical Exercise (COPE) Prehabilitation to Improve Outcomes in Surgical Patients: A Pilot Feasibility Study
Cognitive and functional impairment are debilitating problems for survivors of major surgery. Efforts to modify medical treatments to prevent such impairment are ongoing and may yet yield significant benefits. An area in need of study is whether building patients' cognitive and physical reserve through a prescribed program of cognitive and physical exercise before the physiological insult (a prehabilitation effort) can improve long-term outcomes. Prehabilitation efforts before surgery thus far have focused on preemptive physical therapy to improve post-surgical functional outcomes. No work, however, has been done to attenuate the cognitive decline commonly seen after surgical illness by exercising the brain before the surgical insult. Cognitive prehabilitation is a novel therapeutic approach that applies well-understood techniques derived from brain plasticity research. Our approach is bolstered by data that demonstrate that cognitive training programs are effective and have a very high likelihood of fostering improvement in patient outcomes across a range of populations. It is not yet known if these programs can improve cognitive reserve, allowing patients' minds to better manage the acute stress of surgery and hospitalization. The primary aim of this pilot study is to evaluate the feasibility of cognitive and physical prehabilitation training in adult patients undergoing major non-cardiac surgery who are at risk for postoperative cognitive and functional decline. The secondary aim is to study the effects of cognitive and physical prehabilitation training on cognitive abilities, functional status, and quality of life after surgery.
- Being tested
- Cognitive and physical prehabilitation, Active attention control
- Medical subject headings
- Cognitive Dysfunction, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive and physical prehabilitationBehavioural
Participants engage in cognitive and physical training daily for approximately 2-4 weeks prior to surgery.
Active attention controlOther
Participants will be provided with personal health educational materials and access to the control version of cognitive training program.
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | The active attention control group will receive a binder with information about personal health including sleep hygiene, nutritional changes, and stress reduction. In addition, they will participate in a control version of the cognitive training program. They will receive weekly phone calls by cognitive and physical therapy teams to address issues with any aspects of the program. Receives: Other: Active attention control |
| Cognitive and physical prehabilitation | Experimental | The intervention group will receive the prehabilitation program consisting of a guided progressive program of home-based aerobic and resistance training exercise, which will be adapted based on kinesiologist recommendation for each individual and the individual's perceived exertion. In addition, they will have access to the full cognitive training program. They will receive weekly phone calls by cognitive and physical therapy teams to address issues with any aspects of the program. Receives: Behavioral: Cognitive and physical prehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation log and diary
Proportion of eligible days that patients performed the cognitive and physical prehabilitation program, duration of time per day patients spent on each program
Measured: From date of randomization to surgery, approximately 4 weeks
Secondary outcomes (11)
Cognitive assessment
NIH toolbox cognitive battery
Measured: Approximately 1 month after surgery at the post-surgical clinic follow-up
Instrumental activities of daily living
FAQ questionnaire
Measured: Approximately 1 month after surgery at the post-surgical clinic follow-up
Activities of daily living
ADL questionnaire
Measured: Approximately 1 month after surgery at the post-surgical clinic follow-up
Functional exercise capacity
2 min walk test
Measured: Approximately 1 month after surgery at the post-surgical clinic follow-up
Muscle strength
Hand grip strength
Measured: Approximately 1 month after surgery at the post-surgical clinic follow-up
Pulmonary function
Incentive spirometry
Measured: Approximately 1 month after surgery at the post-surgical clinic follow-up
Acute brain dysfunction
Delirium
Measured: During hospital stay after surgery, for up to 2 weeks
Discharge location
Determination of location where patient was discharged from hospital to, including home, nursing facility, rehab
Measured: From time of surgery until time of discharge or death, whichever came first, assessed up to 30 days
Pain levels
CPOT
Measured: During hospital stay, for up to 2 weeks, and approximately 1 month after surgery at the post-surgical clinic follow-up
Pain levels
NRS
Measured: During hospital stay, for up to 2 weeks, and approximately 1 month after surgery at the post-surgical clinic follow-up
Hospital length of stay
Duration of hospital stay
Measured: From time of surgery until time of discharge or death, whichever came first, assessed 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 posted29 Mar 2017
- Study start1 Mar 2017
- Primary completion1 Sep 2018
- Study completion1 Sep 2018
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 Cognitive ImpairmentStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Hughes, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03094988
- Sponsor's protocol ID
- 161802
- Status last verified
- Jan 2021
- First submitted
- 6 Mar 2017
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rengel KF, Mehdiratta N, Vanston SW, Archer KR, Jackson JC, Thompson JL, Pandharipande PP, Hughes CG. A randomised pilot trial of combined cognitive and physical exercise prehabilitation to improve outcomes in surgical patients. Br J Anaesth. 2021 Feb;126(2):e55-e57. doi: 10.1016/j.bja.2020.11.004. Epub 2020 Dec 13. No abstract available.
PubMed 33317805
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COgnitive and Physical Exercise (COPE) Prehabilitation to Improve Outcomes in Surgical Patients: A Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT03094988
- Acronym / sponsor ID
- 161802
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 29 Mar 2017 (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.
Cognitive and functional impairment are debilitating problems for survivors of major surgery. Efforts to modify medical treatments to prevent such impairment are ongoing and may yet yield significant benefits. An area in need of study is whether building patients' cognitive and physical reserve through a prescribed program of cognitive and physical exercise before the physiological insult (a prehabilitation effort) can improve long-term outcomes. Prehabilitation efforts before surgery thus far have focused on preemptive physical therapy to improve post-surgical functional outcomes. No work, however, has been done to attenuate the cognitive decline commonly seen after surgical illness by exercising the brain before the surgical insult. Cognitive prehabilitation is a novel therapeutic approach that applies well-understood techniques derived from brain plasticity research. Our approach is bolstered by data that demonstrate that cognitive training programs are effective and have a very high likelihood of fostering improvement in patient outcomes across a range of populations. It is not yet known if these programs can improve cognitive reserve, allowing patients' minds to better manage the acute stress of surgery and hospitalization. The primary aim of this pilot study is to evaluate the feasibility of cognitive and physical prehabilitation training in adult patients undergoing major non-cardiac surgery who are at risk for postoperative cognitive and functional decline. The secondary aim is to study the effects of cognitive and physical prehabilitation training on cognitive abilities, functional status, and quality of life after surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Other: Active attention controlThe active attention control group will receive a binder with information about personal health including sleep hygiene, nutritional changes, and stress reduction. In addition, they will participate in a control version of the cognitive training program. They will receive weekly phone calls by cognitive and physical therapy teams to address issues with any aspects of the program. |
| Cognitive and physical prehabilitation | Experimental | Behavioral: Cognitive and physical prehabilitationThe intervention group will receive the prehabilitation program consisting of a guided progressive program of home-based aerobic and resistance training exercise, which will be adapted based on kinesiologist recommendation for each individual and the individual's perceived exertion. In addition, they will have access to the full cognitive training program. They will receive weekly phone calls by cognitive and physical therapy teams to address issues with any aspects of the program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults undergoing major surgery with the likelihood of prolonged hospitalization or critical illness among the following surgical services: general surgery, surgical oncology, otolaryngology, hepatobiliary, thoracic, and vascular surgery
Key exclusion criteria (7 listed)
- Blind, deaf, or unable to speak English, as these conditions would preclude our ability to perform the proposed cognitive and physical program
- Pregnancy
- Prisoners
- Severe frailty or physical impairment that prohibits participation in prehabilitation program
- Patients with documented dementia or cognitive impairment that precludes ability to self-consent for surgery and study participation
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 and physical prehabilitationParticipants engage in cognitive and physical training daily for approximately 2-4 weeks prior to surgery. | Behavioural | Cognitive and physical prehabilitation |
| Active attention controlParticipants will be provided with personal health educational materials and access to the control version of cognitive training program. | Other | Control |
Primary outcome
Participation log and diary
Time frame: From date of randomization to surgery, approximately 4 weeks
Proportion of eligible days that patients performed the cognitive and physical prehabilitation program, duration of time per day patients spent on each program
11 secondary outcomes
Cognitive assessment
Time frame: Approximately 1 month after surgery at the post-surgical clinic follow-up
Instrumental activities of daily living
Time frame: Approximately 1 month after surgery at the post-surgical clinic follow-up
Activities of daily living
Time frame: Approximately 1 month after surgery at the post-surgical clinic follow-up
Functional exercise capacity
Time frame: Approximately 1 month after surgery at the post-surgical clinic follow-up
Muscle strength
Time frame: Approximately 1 month after surgery at the post-surgical clinic follow-up
Pulmonary function
Time frame: Approximately 1 month after surgery at the post-surgical clinic follow-up
Acute brain dysfunction
Time frame: During hospital stay after surgery, for up to 2 weeks
Discharge location
Time frame: From time of surgery until time of discharge or death, whichever came first, assessed up to 30 days
Pain levels
Time frame: During hospital stay, for up to 2 weeks, and approximately 1 month after surgery at the post-surgical clinic follow-up
Pain levels
Time frame: During hospital stay, for up to 2 weeks, and approximately 1 month after surgery at the post-surgical clinic follow-up
Hospital length of stay
Time frame: From time of surgery until time of discharge or death, whichever came first, assessed up to 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
- Results publication: PubMed 33317805Rengel KF, Mehdiratta N, Vanston SW, Archer KR, Jackson JC, Thompson JL, Pandharipande PP, Hughes CG. A randomised pilot trial of combined cognitive and physical exercise prehabilitation to improve outcomes in surgical patients. Br J Anaesth. 2021 Feb;126(2):e55-e57. doi: 10.1016/j.bja.2020.11.004. Epub 2020 Dec 13. No abstract available.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and physical prehabilitation in people with Cognitive Impairment and Physical Impairment, run by Vanderbilt University at 1 site in United States.
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 1 inclusion and 7 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: finished, as of the sponsor's last update on 14 Jan 2021. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participation log and diary (time frame: From date of randomization to surgery, approximately 4 weeks). 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 NCT03094988, 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 14 Jan 2021.