- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04642521
Association Between Anaemia and Handgrip Strength in Female Planned for Major Surgery and the Effect of Intravenous Iron on Handgrip Strength
Anaemia and Handgrip Strength, a Prospective Observatonal Study Amongst Female Population Planned for Major Elective Surgery
This is a sub-study parallel to ProPBM : A Randomised Control Trial Comparing a Modified Patient Blood Management Protocol Against Standard Care for Patients Undergoing Major Surgery (NCT03888768).
Only female participants of ProPBM will be included in this sub-study.
Association between anaemia and handgrip strength and the effect of intravenous iron therapy as part of ProPBM protocol within female participants is elucidated in this study.
Study Overview
Status
Intervention / Treatment
Detailed Description
BACKGROUND:
Maximal physical efforts and aerobic exercise depend highly on adequate oxygen supply provided by haemoglobin and level of iron bound to haemoglobin.
Handgrip strength has been shown to have a strong validity and high reliability in testing the upper body and lower body muscle strength, however its use as a potential tool to identify early anaemic patients planned for surgery is not fully explored. To our knowledge, this study is the first to investigate the diagnostic power of functional performance test within preoperative anaemic population and the change of handgrip strength after administration of intravenous iron.
METHODS:
At recruitment of ProPBM study, all eligible patients for this sub-study will be invited to this sub-study and have their full blood count, ferritin and transferrin saturation recorded and handgrip strength assessed.
After randomization, those within the ProPBM protocol will receive IV iron therapy as indicated. Participants who are randomized to standard care will follow usual medical management.
Participants will be admitted 1 day prior to surgery. On admission, preoperative bloods and handgrip strength will be repeated for patients who were randomized into the ProPBM arm.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: University of Malaya Medical Centre Jalan Universiti
- Phone Number: +60379494422
- Email: ummc@ummc.edu.my
Study Locations
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Kuala Lumpur, Malaysia, 59100
- University Malaya Medical Centre
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Contact:
- Nurafza Ahmad Hisham
- Phone Number: +60124100029
- Email: nurafza@gmail.com
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Sub-Investigator:
- Nurafza Ahmad Hisham
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Principal Investigator:
- Ina I Shariffuddin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Female patients participating in the ProPBM study
- Undergoing major surgery in gynaecology, gastrointestinal surgery and orthopaedics surgery
- The patient must be willing and able to provide informed consent for the study
Exclusion Criteria:
- Patients with known muscle weakness eg myasthenia gravis
- Patients with cerebrovascular or orthopaedic disease that could influence muscle mass and/or upper body function
- Patients in which IV iron is contraindicated eg 1st trimester of pregnancy or known allergy or hypersensitivity to parenteral iron
- Patients with iron overload
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Iron deficiency anaemia
Preoperatively, participants who are iron deficient with or without anaemia will receive intravenous iron (Monofer) as per ProPBM protocol.
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The strength of the dominant hand will be recorded before and after receiving intravenous iron. Each participant will be positioned in a straight back chair with both hand and feet flat on the ground, elbow flexed to 90 degrees with forearm and wrist in the neutral position. Patient's muscle strength will then be tested three times with an interval of one minute between testing and the average of three times will be recorded to the nearest 0.1kg.
Other Names:
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No iron deficiency anaemia
Patient in this group will not be given intravenous iron.
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The strength of the dominant hand will be recorded before and after receiving intravenous iron. Each participant will be positioned in a straight back chair with both hand and feet flat on the ground, elbow flexed to 90 degrees with forearm and wrist in the neutral position. Patient's muscle strength will then be tested three times with an interval of one minute between testing and the average of three times will be recorded to the nearest 0.1kg.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Association between handgrip strength and haemoglobin status within female participants of ProPBM study
Time Frame: At recruitment
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The dependent variable is concentration of plasma circulating haemoglobin (Hb) taken at recruitment and measured in g/dL. The non-dependant variable is the baseline handgrip strength recorded in kilogram using Jamar hydraulic hand dynamometer. Participants will be positioned in a straight back chair with both hand and feet flat on the ground, elbow flexed to 90 degrees with forearm and wrist in the neutral position. Patient's muscle strength will then be tested three times with an interval of one minute between testing and the average of three times will be recorded to the nearest 0.1kg. The association between anaemia and handgrip strength will be analyzed by using binary logistic regression technique. |
At recruitment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Association between handgrip strength and iron status within female participants of ProPBM study
Time Frame: At recruitment
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Iron status is measured by ferritin level (mcg/L) and transferrin saturation (percentage value). Association between iron status and handgrip strength will be analysed using a linear regression technique. |
At recruitment
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Change in handgrip strength in iron deficient female participants of ProPBM study who received intravenous iron
Time Frame: Handgrip strength repeated within 1 month post IV iron administration preoperatively
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Participants who received intravenous iron will have their ferritin level, TSAT and handgrip strength reassesed during preoperative admission. Handgrip strength after IV iron administration will be compared to baseline handgrip strength. |
Handgrip strength repeated within 1 month post IV iron administration preoperatively
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ina I Shariffuddin, Ministry of Health, Malaysia
Publications and helpful links
General Publications
- Roberts HC, Denison HJ, Martin HJ, Patel HP, Syddall H, Cooper C, Sayer AA. A review of the measurement of grip strength in clinical and epidemiological studies: towards a standardised approach. Age Ageing. 2011 Jul;40(4):423-9. doi: 10.1093/ageing/afr051. Epub 2011 May 30.
- Joosten E, Detroyer E, Milisen K. Effect of anaemia on hand grip strength, walking speed, functionality and 1 year mortality in older hospitalized patients. BMC Geriatr. 2016 Aug 19;16(1):153. doi: 10.1186/s12877-016-0326-y.
- Santos PHS, Carmo EA, Carneiro JAO, Nery AA, Casotti CA. Handgrip strength: An effective screening instrument for anemia in the elderly women. Public Health Nurs. 2019 Mar;36(2):178-183. doi: 10.1111/phn.12579. Epub 2019 Jan 9.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Anaemiahandgrip
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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