FrailtyNCT02966470
Hand Grip Strength as a Marker of Frailty in Surgical Patients
An observational study of Frailty, run by Yale University at 1 site in United States.
Trial summary
This study aims to assess if grip strength can be used as a single, objective surrogate of frailty assessment in the surgical population. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Frailty
- What is being tested?
- Obtain grip strength from a standardized gripometer
- Type of treatment
- Medical device
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2018to 25 Sep 2019
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: General surgery patients admitted to the Section of General Surgery, Trauma, and Surgical Critical Care who are over the age of 60.
Who may be able to join
- General surgery patient admitted to the Section of General Surgery, Trauma, and Surgical Critical Care
- Age >60
Who cannot join
- Pregnancy
- Untreated or metastatic malignancy
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale School of Medicine
New Haven, Connecticut, 06520
About this study
This study aims to assess if grip strength can be used as a single, objective surrogate of frailty assessment in the surgical population.
Read the 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.
- Conditions
- Frailty
- Being tested
- Obtain grip strength from a standardized gripometer
- Keywords
- surgical outcomes
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obtain grip strength from a standardized gripometerDevice
Obtain grip strength from a standardized gripometer, 3 times on each hand
| Study group | Role | What they receive |
|---|---|---|
| General surgery patient | General surgery patient admitted to the Section of General Surgery, Trauma, and Surgical Critical Care who are over 60. Receives: Device: Obtain grip strength from a standardized gripometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
linear regression of grip strength to frailty survey score
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.
Measured: 10 minutes at the time of admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study start1 Feb 2018
- Primary completion25 Sep 2019
- Study completion25 Sep 2019
Why it stopped: Due to accrual not met and PI no longer at the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bishwajit Bhattacharya, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02966470
- Sponsor's protocol ID
- 1609018398
- Status last verified
- Feb 2020
- First submitted
- 15 Nov 2016
- Last updated
- 10 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hand Grip Strength as a Marker of Frailty in Surgical Patients
- ClinicalTrials.gov ID
- NCT02966470
- Acronym / sponsor ID
- 1609018398
- Conditions
- Frailty
- Keywords
- surgical outcomes
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to accrual not met and PI no longer at the institution
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 25 Sep 2019 (actual)
- Study completion
- 25 Sep 2019 (actual)
- First posted
- 17 Nov 2016 (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.
This study aims to assess if grip strength can be used as a single, objective surrogate of frailty assessment in the surgical population.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| General surgery patient | – | Device: Obtain grip strength from a standardized gripometerGeneral surgery patient admitted to the Section of General Surgery, Trauma, and Surgical Critical Care who are over 60. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- General surgery patients admitted to the Section of General Surgery, Trauma, and Surgical Critical Care who are over the age of 60.
Key inclusion criteria (2 listed)
- General surgery patient admitted to the Section of General Surgery, Trauma, and Surgical Critical Care
- Age >60
Key exclusion criteria (3 listed)
- Pregnancy
- Untreated or metastatic malignancy
- Prisoners
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 |
|---|---|---|
| Obtain grip strength from a standardized gripometerObtain grip strength from a standardized gripometer, 3 times on each hand | Device | General surgery patient |
Primary outcome
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.
Results and safety
The study was stopped early (reason given: Due to accrual not met and PI no longer at the institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2020.
- Individual participant dataSharing planned: No
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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.
Bishwajit Bhattacharya, MD principal investigator
Yale University
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 Frailty, run by Yale 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 2 inclusion and 3 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: stopped early, as of the sponsor's last update on 10 Feb 2020. 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 was stopped early (reason given: Due to accrual not met and PI no longer at the institution). Results are not available in the source record.
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?
linear regression of grip strength to frailty survey score (time frame: 10 minutes at the time of admission). It is what the study was designed to measure, not a finding.
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 10 Feb 2020.