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

NCT04642521 | Unknown

• 1 other identifier: Anaemiahandgrip
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia; Iron-deficiency; Patient Blood Management; Iron Deficiency Anemia

Keywords

handgrip strength; intravenous iron

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Association between handgrip strength and iron status within female participants of ProPBM study

  At recruitment

• Change in handgrip strength in iron deficient female participants of ProPBM study who received intravenous iron

  Handgrip strength repeated within 1 month post IV iron administration preoperatively

Study Arms (2)

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

No iron deficiency anaemia

Patient in this group will not be given intravenous iron.

Device: Jamar hydraulic hand dynamometer

Interventions

Jamar hydraulic hand dynamometer DEVICE

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.

Also known as: Handgrip strength

Iron deficiency anaemia; No iron deficiency anaemia

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Female population
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Malaya: lead
• Ministry of Health, Malaysia: collaborator

Study Sites (1)

University Malaya Medical Centre

Kuala Lumpur, 59100, Malaysia

Location

Related Publications (3)

• 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.

  PMID: 21624928 BACKGROUND

• 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.

  PMID: 27543049 BACKGROUND

• 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.

  PMID: 30628133 RESULT

MeSH Terms

Conditions

Anemia; Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Anemia, Hypochromic; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ina I Shariffuddin

  Ministry of Health, Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

University of Malaya Medical Centre Jalan Universiti

CONTACT

+60379494422; ummc@ummc.edu.my

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2020
• First Posted: November 24, 2020
• Study Start: November 18, 2020
• Primary Completion: March 31, 2021
• Study Completion: April 30, 2021
• Last Updated: November 24, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)