Association Between Anaemia and Handgrip Strength in Female Planned for Major Surgery and the Effect of Intravenous Iron on Handgrip Strength
NCT ID: NCT04642521
Last Updated: 2020-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
65 participants
OBSERVATIONAL
2020-11-18
2021-04-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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.
Jamar hydraulic hand dynamometer
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.
No iron deficiency anaemia
Patient in this group will not be given intravenous iron.
Jamar hydraulic hand dynamometer
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.
Interventions
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Jamar hydraulic hand dynamometer
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
80 Years
FEMALE
Yes
Sponsors
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Ministry of Health, Malaysia
OTHER_GOV
University of Malaya
OTHER
Responsible Party
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Principal Investigators
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Ina I Shariffuddin
Role: PRINCIPAL_INVESTIGATOR
Ministry of Health, Malaysia
Locations
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University Malaya Medical Centre
Kuala Lumpur, , Malaysia
Countries
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Central Contacts
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University of Malaya Medical Centre Jalan Universiti
Role: CONTACT
Phone: +60379494422
Email: [email protected]
Facility Contacts
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Nurafza Ahmad Hisham
Role: primary
References
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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.
Other Identifiers
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Anaemiahandgrip
Identifier Type: -
Identifier Source: org_study_id