SarcopeniaNCT05546671
Impact of Hand Grip Strength on Length of Hospital Stay After Cardiac Surgery Among Elderly Patients
An observational study of Sarcopenia and Frailty, run by Kartal Kosuyolu High Speciality Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Sarcopenia, Frailty
- What is being tested?
- Hand grip strength measurement
- How many people
- 240 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2022to 30 Nov 2024
- 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 70 years and older
- All sexes
- Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kosuyolu High Specialization Education and Research Hospital
Istanbul, 34865
Ahmet Can Topcu, MD, 902165001500, ahmet.topcu@icloud.com
Murat Bulent Rabus, Prof, 902165001500, muratbulent.rabus@sbu.edu.tr
About this study
Official title: Usefulness of Hand Grip Strength as a Predictor of Prolonged Hospital Stay in Elderly Patients Undergoing Cardiac Surgery
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.
- Conditions
- Sarcopenia, Frailty
- Being tested
- Hand grip strength measurement
- Medical subject headings
- Sarcopenia, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand grip strength measurementDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| Strong grippers | Not described Receives: Diagnostic Test: Hand grip strength measurement | |
| Weak grippers | Not described Receives: Diagnostic Test: Hand grip strength measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prolonged hospital stay
Prolonged hospital stay is defined as postoperative hospital stay for ≥14 days.
Measured: 14 days
Secondary outcomes (2)
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.
Measured: 48 hours
Prolonged mechanical ventilation
Prolonged mechanical ventilation is defined as mechanical ventilation of >12 hours. This includes re-intubations and non-invasive mechanical ventilation.
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start1 Nov 2022
- Primary completion31 Oct 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- 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
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kartal Kosuyolu High Speciality Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ahmet Can Topcu, Kartal Kosuyolu High Speciality Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05546671
- Sponsor's protocol ID
- 2022/13/621
- Status last verified
- Mar 2024
- First submitted
- 15 Sep 2022
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30864228Fu 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.
PubMed 31775633Fried 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.
PubMed 11253156
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Hand Grip Strength as a Predictor of Prolonged Hospital Stay in Elderly Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT05546671
- Acronym / sponsor ID
- 2022/13/621
- Conditions
- Sarcopenia, Frailty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Kartal Kosuyolu High Speciality Training and Research HospitalOther government
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 21 Sep 2022 (actual)
- 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strong grippers | – | Diagnostic Test: Hand grip strength measurement |
| Weak grippers | – | Diagnostic Test: Hand grip strength measurement |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Age groups
- Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
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 |
|---|---|---|
| Hand grip strength measurementPreoperative 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 | Diagnostic test | Strong grippers, Weak grippers |
Primary outcome
Prolonged hospital stay
Time frame: 14 days
Prolonged hospital stay is defined as postoperative hospital stay for ≥14 days.
2 secondary outcomes
Prolonged intensive care unit stay
Time frame: 48 hours
Prolonged mechanical ventilation
Time frame: 12 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Background: PubMed 30864228Perry 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.
- Background: PubMed 31775633Fu 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.
- Background: PubMed 11253156Fried 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.
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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.
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 Sarcopenia and Frailty, run by Kartal Kosuyolu High Speciality Training and Research Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 15 Mar 2024. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmet Can Topcu, MD (902165001500, ahmet.topcu@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prolonged hospital stay (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05546671, which also lists 3 linked publications.
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 15 Mar 2024.