COgnitive and Physical Exercise to Improve Outcomes After Surgery (COPE-iOS) Study

Surgery Clinical Trial

— COPEiOS  

Official title:

COgnitive and Physical Exercise to Improve Outcomes After Surgery (COPE-iOS) Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04889417
• Other study ID #: U11775
• Secondary ID: 1R01AG061161-01A
• Status: Recruiting
• Phase: N/A
• Start date: October 12, 2021
• Est. completion date: July 1, 2027

Study information

• Verified date: April 2024
• Source: Vanderbilt University Medical Center
• Contact: Christopher G Hughes, MD
• Phone: 16153436268
• Email: christopher.hughes[@]vumc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The COgnitive and Physical Exercise to improve Outcomes after Surgery (COPE-iOS) study is testing the hypothesis that a pragmatic program combining computerized cognitive training and physical training throughout the perioperative period will improve long-term cognitive and disability outcomes in older surgical patients at high risk for decline. To accomplish these goals, the Investigators are randomizing 250 patients ≥60 years old undergoing elective major non-cardiac surgery with expected hospitalization ≥3 days to a pragmatic comprehensive training program (computerized cognitive training and supervised progressive physical exercise) or to active control (control computer game, stretching exercises) for 2-4 weeks prior to surgery and for 3 months after discharge. At baseline and after discharge, the Investigators will assess global cognition, activities of daily living, depression, endothelial and blood brain barrier function (blood biomarkers), and neuroimaging (anatomical and functional MRI). In this early stage trial, the Investigators will determine if certain subgroups benefit most, program aspects with greatest effect on outcomes, mechanistic associations with outcomes, and additional exploratory analyses.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: July 1, 2027
• Est. primary completion date: July 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

1. =60 years old

2. undergoing elective major non-cardiac surgery with expected hospitalization =3 days

Exclusion Criteria:

1. Blind, deaf, or inability to understand English as these conditions would preclude the ability to perform the proposed comprehensive program and prevent assessment with the study instruments

2. Prisoners

3. Severe frailty or physical impairment that prohibits participation in the program

4. Cognitively unable to consent for surgery (i.e., dementia or cognitive impairment of a severity that precludes ability to self-consent and, thus, also participation in study interventions)

5. Inability to obtain informed consent =2 weeks before scheduled surgery

6. Surgical team unwilling to allow physical activity or other components of the intervention

7. Inability or unwillingness to utilize a tablet device, laptop, or email

8. Co-enrolled in another interventional trial examining similar outcomes or current enrollment in a study that does not allow co-enrollment

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Disability Physical
• Surgery

Intervention

Behavioral:
• Comprehensive training program
The COPE-iOS program is a pragmatic comprehensive training program that combines computerized cognitive training and progressive supervised video conference physical exercise sessions performed 2-4 weeks prior to surgery and for 3 months after discharge.
• Active control
The active attention control will include control computer games and supervised video conference stretching exercises performed 2-4 weeks prior to surgery and for 3 months after discharge.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Program compliance	Compliance with program, feasibility	before surgery up to 3 months after discharge
Other	Delirium	Confusion assessment method in the ICU	up to 14 days in the hospital
Other	Length of stay	Length of stay in the hospital	through hospital admission, an average of up to 14 days
Other	Discharge location	Home, rehabilitation, skilled nursing facility, hospice	through hospital admission, an average of up to 14 days
Other	Functional status	Duke Activity Status Index	3 and 12 months after discharge
Other	Aerobic exercise capacity	6-minute walk test	3 months after discharge
Other	Chronic Pain	Behavioral Pain Index	3 and 12 months after discharge
Primary	Global cognition	Computerized Neuropsychological Scale (CNS) Vital Signs neurocognitive battery	3 months after discharge
Secondary	Global cognition	Computerized Neuropsychological Scale (CNS) Vital Signs neurocognitive battery	12 months after discharge
Secondary	Basic activities of daily living	Katz activities of daily living	3 and 12 months after discharge
Secondary	Instrumental activities of daily living	Functional activities questionnaire	3 and 12 months after discharge
Secondary	Depression	Depression Anxiety and Stress Scale (DASS)	3 and 12 months after discharge
Secondary	Endothelial injury	Plasma biomarker	day of surgery, postoperative day 2, postoperative day 5, and 3 months after discharge
Secondary	Blood brain barrier injury	Plasma biomarker	day of surgery, postoperative day 2, postoperative day 5, and 3 months after discharge
Secondary	Brain magnetic resonance imaging	Anatomical and functional magnetic resonance imaging of the brain	3 months after discharge