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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05546671
Other study ID # 2022/13/621
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2022
Est. completion date November 30, 2024

Study information

Verified date March 2024
Source Kartal Kosuyolu High Speciality Training and Research Hospital
Contact Ahmet Can Topcu, MD
Phone 902165001500
Email ahmet.topcu@icloud.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Hand grip strength has been shown to be a predictor of adverse cardiovascular outcomes in the elderly population. This study aims to investigate whether measurement of hand grip strength could be used as a predictor of prolonged hospital stay after cardiac surgery in elderly patients.


Recruitment information / eligibility

Status Recruiting
Enrollment 240
Est. completion date November 30, 2024
Est. primary completion date October 31, 2024
Accepts healthy volunteers
Gender All
Age group 70 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Hand grip strength measurement
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

Locations

Country Name City State
Turkey Kosuyolu High Specialization Education and Research Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Kartal Kosuyolu High Speciality Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Prolonged hospital stay Prolonged hospital stay is defined as postoperative hospital stay for =14 days. 14 days
Secondary Prolonged intensive care unit stay 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
Secondary Prolonged mechanical ventilation Prolonged mechanical ventilation is defined as mechanical ventilation of >12 hours. This includes re-intubations and non-invasive mechanical ventilation. 12 hours
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