- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05546671
Impact of Hand Grip Strength on Length of Hospital Stay After Cardiac Surgery Among Elderly Patients
Usefulness of Hand Grip Strength as a Predictor of Prolonged Hospital Stay in Elderly Patients Undergoing Cardiac Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ahmet Can Topcu, MD
- Phone Number: 902165001500
- Email: ahmet.topcu@icloud.com
Study Contact Backup
- Name: Murat Bulent Rabus, Prof
- Phone Number: 902165001500
- Email: muratbulent.rabus@sbu.edu.tr
Study Locations
-
-
-
Istanbul, Turkey, 34865
- Recruiting
- Kosuyolu High Specialization Education and Research Hospital
-
Contact:
- Ahmet Can Topcu, MD
- Phone Number: 902165001500
- Email: ahmet.topcu@icloud.com
-
Contact:
- Murat Bulent Rabus, Prof
- Phone Number: 902165001500
- Email: muratbulent.rabus@sbu.edu.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥70 years
- Undergoing isolated coronary artery bypass grafting or isolated valve surgery or combined coronary and valve procedures
- Being oriented and cooperative enough to understand and comply with the instruction of gripping the hand dynamometer
Exclusion Criteria:
- Age <70 years
- Emergent status
- Hemodynamic instability
- Inability to cooperate due to neurocognitive disorder
- Loss of upper extremity motor function of any degree (such as due to previous stroke)
- History of upper extremity amputation of any level
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Strong grippers
|
Preoperative hand grip strength will be measured in kilograms using a digital hand dynamometer (Baseline Smedley Digital Hand Dynamometer, Model 12-0286, Baseline Evaluation Instruments, China). Participants will be instructed to grip the hand dynamometer for 5 seconds with their dominant hand 3 times. They will be allowed to rest for 20 second between each grip. The highest measurement of 3 attempts will be recorded. Participants will be categorized as "strong grippers" or "weak grippers" according to Fried criteria as previously defined by Linda P. Fried and colleagues. A weak grip will be defined as follows: For men: BMI ≤24: hand grip strength ≤29 kg; BMI =24.1 to 28: hand grip strength ≤30 kg; BMI >28: hand grip strength ≤32 kg For women: BMI ≤23: hand grip strength ≤17 kg; BMI =23.1 to 26: hand grip strength ≤17.3 kg; BMI =26.1 to 29: hand grip strength ≤18 kg; BMI >29: hand grip strength ≤21 kg |
Weak grippers
|
Preoperative hand grip strength will be measured in kilograms using a digital hand dynamometer (Baseline Smedley Digital Hand Dynamometer, Model 12-0286, Baseline Evaluation Instruments, China). Participants will be instructed to grip the hand dynamometer for 5 seconds with their dominant hand 3 times. They will be allowed to rest for 20 second between each grip. The highest measurement of 3 attempts will be recorded. Participants will be categorized as "strong grippers" or "weak grippers" according to Fried criteria as previously defined by Linda P. Fried and colleagues. A weak grip will be defined as follows: For men: BMI ≤24: hand grip strength ≤29 kg; BMI =24.1 to 28: hand grip strength ≤30 kg; BMI >28: hand grip strength ≤32 kg For women: BMI ≤23: hand grip strength ≤17 kg; BMI =23.1 to 26: hand grip strength ≤17.3 kg; BMI =26.1 to 29: hand grip strength ≤18 kg; BMI >29: hand grip strength ≤21 kg |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prolonged hospital stay
Time Frame: 14 days
|
Prolonged hospital stay is defined as postoperative hospital stay for ≥14 days.
|
14 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prolonged intensive care unit stay
Time Frame: 48 hours
|
Prolonged intensive care unit stay is defined as postoperative intensive care unit stay for >48 hours.
This includes sum of all time spent in intensive care unit including unplanned returns.
|
48 hours
|
Prolonged mechanical ventilation
Time Frame: 12 hours
|
Prolonged mechanical ventilation is defined as mechanical ventilation of >12 hours.
This includes re-intubations and non-invasive mechanical ventilation.
|
12 hours
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
- Perry IS, Pinto LC, da Silva TK, Vieira SRR, Souza GC. Handgrip Strength in Preoperative Elective Cardiac Surgery Patients and Association With Body Composition and Surgical Risk. Nutr Clin Pract. 2019 Oct;34(5):760-766. doi: 10.1002/ncp.10267. Epub 2019 Mar 13.
- Fu L, Zhang Y, Shao B, Liu X, Yuan B, Wang Z, Chen T, Liu Z, Liu X, Guo Q. Perioperative poor grip strength recovery is associated with 30-day complication rate after cardiac surgery discharge in middle-aged and older adults - a prospective observational study. BMC Cardiovasc Disord. 2019 Nov 27;19(1):266. doi: 10.1186/s12872-019-1241-x.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022/13/621
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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