NCT05546671

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 21, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

2 years

First QC Date

September 15, 2022

Last Update Submit

March 12, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prolonged hospital stay

    Prolonged hospital stay is defined as postoperative hospital stay for ≥14 days.

    14 days

Secondary Outcomes (2)

  • Prolonged intensive care unit stay

    48 hours

  • Prolonged mechanical ventilation

    12 hours

Study Arms (2)

Strong grippers

Diagnostic Test: Hand grip strength measurement

Weak grippers

Diagnostic Test: Hand grip strength measurement

Interventions

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

Strong grippersWeak grippers

Eligibility Criteria

Age70 Years+
Sexall
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study population will be comprised of all consecutive patients ≥70 years of age undergoing elective coronary artery bypass and/or valve surgery at the Department of Cardiovascular Surgery at Kosuyolu Training and Research Hospital.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kosuyolu High Specialization Education and Research Hospital

Istanbul, 34865, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • 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.

    PMID: 30864228BACKGROUND
  • 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.

    PMID: 31775633BACKGROUND
  • 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.

    PMID: 11253156BACKGROUND

MeSH Terms

Conditions

SarcopeniaFrailty

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsPathologic Processes

Central Study Contacts

Ahmet Can Topcu, MD

CONTACT

Murat Bulent Rabus, Prof

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardiovascular Surgery Specialist

Study Record Dates

First Submitted

September 15, 2022

First Posted

September 21, 2022

Study Start

November 1, 2022

Primary Completion

October 31, 2024

Study Completion

November 30, 2024

Last Updated

March 15, 2024

Record last verified: 2024-03

Locations