Association Between Anaemia and Handgrip Strength in Female Planned for Major Surgery and the Effect of Intravenous Iron on Handgrip Strength

Anemia Clinical Trial

Official title:

Anaemia and Handgrip Strength, a Prospective Observatonal Study Amongst Female Population Planned for Major Elective Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04642521
• Other study ID #: Anaemiahandgrip
• Status: Not yet recruiting
• Start date: November 18, 2020
• Est. completion date: April 30, 2021

Study information

• Verified date: November 2020
• Source: University of Malaya
• Contact: University of Malaya Medical Centre Jalan Universiti
• Phone: +60379494422
• Email: ummc[@]ummc.edu.my
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 65
• Est. completion date: April 30, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Iron Deficiency Anemia
• Iron-deficiency
• Patient Blood Management

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Malaysia	University Malaya Medical Centre	Kuala Lumpur

Sponsors (2)

Lead Sponsor	Collaborator
University of Malaya	Ministry of Health, Malaysia

Country where clinical trial is conducted

Malaysia, 

References & Publications (3)

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. — View Citation

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. Review. — View Citation

Santos PHS, Carmo ÉA, 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association between handgrip strength and haemoglobin status within female participants of ProPBM study	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
Secondary	Association between handgrip strength and iron status within female participants of ProPBM study	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
Secondary	Change in handgrip strength in iron deficient female participants of ProPBM study who received intravenous iron	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