HealthyPERFORMNCT00487890
Performance Evaluation and Research for Older Adults Requiring Major Surgery
An observational study of Healthy, run by University of Washington at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 214 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2004to 31 Aug 2009
- Phase
- Observational
- 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
Study population: Adults, aged 65 and older, who are undergoing an abdominal or cardiothoracic surgical procedure at the University of Washington Medical Center in Seattle, WA.
Who may be able to join
- 65 years or older;
- Having abdominal surgery;
- Informed consent obtained;
- All races/ethnicities;
- Both genders
Who cannot join
- Non-English speaking;
- Unwillingness to participate;
- Unavailable for follow-up phone calls;
- Unable to communicate with researchers;
- Unable to pass the screening test
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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 patient's 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.
- Conditions
- Healthy
- Keywords
- Geriatric, Abdominal, Surgery, gastrointestinal surgery, intrabdominal surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2007 (estimated)
- Study start1 Apr 2004
- Primary completion31 Dec 2008
- Study completion31 Aug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, David Flum, University of Washington
- Investigators
- David R Flum, MD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00487890
- Sponsor's protocol ID
- 25699
- Acronym
- PERFORM
- Status last verified
- Dec 2022
- First submitted
- 15 Jun 2007
- Last updated
- 20 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Evaluation and Research for Older Adults Requiring Major Surgery
- ClinicalTrials.gov ID
- NCT00487890
- Acronym / sponsor ID
- PERFORM / 25699
- Conditions
- Healthy
- Keywords
- Geriatric, Abdominal, Surgery, gastrointestinal surgery, intrabdominal surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 1 Apr 2004 (actual)
- Primary completion
- 31 Dec 2008 (actual)
- Study completion
- 31 Aug 2009 (actual)
- First posted
- 19 Jun 2007 (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.
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 patient's 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 design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Adults, aged 65 and older, who are undergoing an abdominal or cardiothoracic surgical procedure at the University of Washington Medical Center in Seattle, WA.
Key inclusion criteria (5 listed)
- 65 years or older;
- Having abdominal surgery;
- Informed consent obtained;
- All races/ethnicities;
- Both genders
Key exclusion criteria (5 listed)
- Non-English speaking;
- Unwillingness to participate;
- Unavailable for follow-up phone calls;
- Unable to communicate with researchers;
- Unable to pass the screening test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 20 Dec 2022.
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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.
David R Flum, MD, MPH principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by University of Washington 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 5 inclusion and 5 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 20 Dec 2022. 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.
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 20 Dec 2022.