- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02966470
Hand Grip Strength as a Marker of Frailty in Surgical Patients
February 6, 2020 updated by: Yale University
This study aims to assess if grip strength can be used as a single, objective surrogate of frailty assessment in the surgical population.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
Frailty is associated with worse outcomes.
Current screening surveys are cumbersome, most containing multiple components.
For frail patients particularly, it can be difficult to ascertain all the information requested.
There is a need for a simple, one step, objective screening measure of frailty.
There is some evidence in the medicine patients that grip strength may be related to frailty, but no such information is available for surgical patients.
Study Type
Observational
Enrollment (Actual)
52
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Connecticut
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New Haven, Connecticut, United States, 06520
- Yale School of Medicine
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
General surgery patients admitted to the Section of General Surgery, Trauma, and Surgical Critical Care who are over the age of 60.
Description
Inclusion Criteria:
- General surgery patient admitted to the Section of General Surgery, Trauma, and Surgical Critical Care
- Age >60
Exclusion Criteria:
- Pregnancy
- Untreated or metastatic malignancy
- Prisoners
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
General surgery patient
General surgery patient admitted to the Section of General Surgery, Trauma, and Surgical Critical Care who are over 60.
|
Obtain grip strength from a standardized gripometer, 3 times on each hand
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
linear regression of grip strength to frailty survey score
Time Frame: 10 minutes at the time of admission
|
Their frailty survey and grip strength scores will also be recorded for analysis. We will analyze the data by linear regression of grip strength to frailty survey score. |
10 minutes at the time of admission
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bishwajit Bhattacharya, MD, Yale University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2018
Primary Completion (Actual)
September 25, 2019
Study Completion (Actual)
September 25, 2019
Study Registration Dates
First Submitted
November 15, 2016
First Submitted That Met QC Criteria
November 15, 2016
First Posted (Estimate)
November 17, 2016
Study Record Updates
Last Update Posted (Actual)
February 10, 2020
Last Update Submitted That Met QC Criteria
February 6, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1609018398
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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