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

• ClinicalTrials.gov Identifier: NCT04642521
• Recruitment Status: Not yet recruiting
• First Posted: November 24, 2020
• Last Update Posted: November 24, 2020
• Sponsor: University of Malaya
• Collaborator: Ministry of Health, Malaysia
• Information provided by (Responsible Party): University of Malaya

Study Description

Brief 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.

Condition or disease	Intervention/treatment
Anemia; Iron-deficiency; Patient Blood Management; Iron Deficiency Anemia	Device: Jamar hydraulic hand dynamometer

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 Design

• Study Type: Observational
• Estimated Enrollment: 65 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Anaemia and Handgrip Strength, a Prospective Observatonal Study Amongst Female Population Planned for Major Elective Surgery
• Estimated Study Start Date: November 18, 2020
• Estimated Primary Completion Date: March 31, 2021
• Estimated Study Completion Date: April 30, 2021

Groups and Cohorts

Group/Cohort	Intervention/treatment
Iron deficiency anaemia; Preoperatively, participants who are iron deficient with or without anaemia will receive intravenous iron (Monofer) as per ProPBM protocol.	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.; Other Name: Handgrip strength
No iron deficiency anaemia; Patient in this group will not be given intravenous iron.	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.; Other Name: Handgrip strength

Outcome Measures

Primary Outcome Measures :

1. Association between handgrip strength and haemoglobin status within female participants of ProPBM study [ Time Frame: At recruitment ]

   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.

Secondary Outcome Measures :

1. Association between handgrip strength and iron status within female participants of ProPBM study [ Time Frame: At recruitment ]

   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.

2. 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 ]

   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Female population
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

Female participants of ProPBM study who are planned for major elective surgery, both anaemic and non anaemic patients are included

Criteria

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

Contacts and Locations

Contacts

Contact: University of Malaya Medical Centre Jalan Universiti; +60379494422; ummc@ummc.edu.my

Locations

Malaysia

University Malaya Medical Centre

Kuala Lumpur, Malaysia, 59100

Contact: Nurafza Ahmad Hisham +60124100029 nurafza@gmail.com

Sub-Investigator: Nurafza Ahmad Hisham

Principal Investigator: Ina I Shariffuddin

Sponsors and Collaborators

University of Malaya

Ministry of Health, Malaysia

Investigators

• Principal Investigator: Ina I Shariffuddin; Ministry of Health, Malaysia

More Information

Publications of Results:

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.

Other 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. Review.

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.

• Responsible Party: University of Malaya
• ClinicalTrials.gov Identifier: NCT04642521
• Other Study ID Numbers: Anaemiahandgrip
• First Posted: November 24, 2020
• Last Update Posted: November 24, 2020
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Study protocol, statistic analysis plan

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Malaya:

handgrip strength; intravenous iron

Additional relevant MeSH terms:

Anemia; Anemia, Iron-Deficiency; Hematologic Diseases; Anemia, Hypochromic; Iron Metabolism Disorders; Metabolic Diseases