Clinical trial NCT04642521: Association Between Anaemia and Handgrip Strength in Female Planned for Major Surgery and the Effect of Intravenous Iron on Handgrip Strength
Official title: Anaemia and Handgrip Strength, a Prospective Observatonal Study Amongst Female Population Planned for Major Elective Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anemia
Iron-deficiency
Patient Blood Management
Iron Deficiency Anemia
Keywords: handgrip strength
intravenous iron
Lead sponsor: University of Malaya
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Malaysia
First posted: 2020-11-24
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility 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

Primary outcomes:
measure: Association between handgrip strength and haemoglobin status within female participants of ProPBM study
timeFrame: At recruitment
Secondary outcomes:
measure: Association between handgrip strength and iron status within female participants of ProPBM study
timeFrame: At recruitment
measure: Change in handgrip strength in iron deficient female participants of ProPBM study who received intravenous iron
timeFrame: Handgrip strength repeated within 1 month post IV iron administration preoperatively
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
Study officials:
affiliation: Ministry of Health, Malaysia
name: Ina I Shariffuddin
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
citation: 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.