Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00487890
Status:
COMPLETED
Last Update Posted:
2022-12-20
First Post:
2007-06-15
Brief Title:
Performance Evaluation and Research for Older Adults Requiring Major Surgery
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Performance Evaluation and Research for Older Adults Requiring Major Surgery
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PERFORM
Brief Summary:
The purpose is to identify modifiable factors in older adults associated with functional decline following major non-emergent surgery The hypothesis of this proposal is that poor preoperative exercise tolerance and physical performance potentially modifiable factors are crucial in predicting functional decline and disability following surgery When completed this study will reveal detailed information on the incidence and risk factors for functional decline in older adults following surgery It will direct future research targeting interventions in older adults at highest risk for functional decline following surgery thereby decreasing the incidence of premature disability
Detailed Description:
This prospective cohort study will follow 400 patients undergoing major non-emergent abdominal or cardiothoracic surgery at the University of Washington Medical Center Patients 65 and older will be recruited following introduction of the study by a health-care provider The provider will give the patient a study pamphlet and letter outlining the study Patients who express interest in the study will meet with a Research Coordinator The Coordinator will describe the study answer all questions and have the patient review and provide written informed consent The Mini-cog a validated brief dementia screen with high sensitivity and specificity will be used to determine if patients have a potential cognitive impairment Participants who recall all 3 words correctly or draw a normal clock will be considered cognitively intact and able to provide consent and to participate in the study Participants who are unable to recall any words or who draw an abnormal clock will be ineligible for the study and classified as having a potential cognitive impairment
Consenting patients will be asked questions about their medical history and health status The Research Coordinator will only ask questions that are relevant to the patients medical care The 5-item version of the Geriatric Depression Scale will assess patients for active depression This short version has been validated and found to be highly sensitive and specific for diagnosing depression Patients will also be asked to complete the Duke Activity Status Index and the Health Assessment Questionnaire These questions will take 10-15 minutes
Patients will be asked to perform physical tasks These tasks will include a physical performance measure Patients will only be asked to complete tasks that they are comfortable performing The physical performance measures include 1 a timed 10-ft walk at normal pace 2 a timed test of repetitive chair stands 3 a hierarchial balance task and 4 testing of grip strength In the timed walk patients are asked to walk at normal pace for 10 feet This task is completed twice with the average of the times calculated In the timed test of 5 repetitive chair stands patients are asked to fold their arms across their chest and to rise from the seated position 5 times as quickly as possible To assess balance patients are asked to stand with their feet side-by-side followed by semi-tandem and tandem and to hold each position for 10 seconds Scores are allotted based upon how far each participant is able to progress To test grip strength a handheld dynamometer will be used Using an isometric dynamometer the best score of the 3 squeezes from the dominant hand will be the value calculated
Patients will be asked to complete the EQ-5D SF-36 and Health Assessment Questionnaires at 1 week 1 month 3 months and 12 months following their surgery as well as the CNAQ Appetite Questionnaire but only at the 1 month 3 month and 1 year follow up intervals The Research Coordinator will contact them by phone to complete these questionnaires If the patient is still in the hospital at the University of Washington 1 week following their surgery the Research Coordinator will meet with them to complete the questionnaires
Consenting patients will be asked questions about their medical history and health status The Research Coordinator will only ask questions that are relevant to the patients medical care The 5-item version of the Geriatric Depression Scale will assess patients for active depression This short version has been validated and found to be highly sensitive and specific for diagnosing depression Patients will also be asked to complete the Duke Activity Status Index and the Health Assessment Questionnaire These questions will take 10-15 minutes
Patients will be asked to perform physical tasks These tasks will include a physical performance measure Patients will only be asked to complete tasks that they are comfortable performing The physical performance measures include 1 a timed 10-ft walk at normal pace 2 a timed test of repetitive chair stands 3 a hierarchial balance task and 4 testing of grip strength In the timed walk patients are asked to walk at normal pace for 10 feet This task is completed twice with the average of the times calculated In the timed test of 5 repetitive chair stands patients are asked to fold their arms across their chest and to rise from the seated position 5 times as quickly as possible To assess balance patients are asked to stand with their feet side-by-side followed by semi-tandem and tandem and to hold each position for 10 seconds Scores are allotted based upon how far each participant is able to progress To test grip strength a handheld dynamometer will be used Using an isometric dynamometer the best score of the 3 squeezes from the dominant hand will be the value calculated
Patients will be asked to complete the EQ-5D SF-36 and Health Assessment Questionnaires at 1 week 1 month 3 months and 12 months following their surgery as well as the CNAQ Appetite Questionnaire but only at the 1 month 3 month and 1 year follow up intervals The Research Coordinator will contact them by phone to complete these questionnaires If the patient is still in the hospital at the University of Washington 1 week following their surgery the Research Coordinator will meet with them to complete the questionnaires
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None