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

November 18, 2020 updated by: University of Malaya

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

65

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: University of Malaya Medical Centre Jalan Universiti
  • Phone Number: +60379494422
  • Email: ummc@ummc.edu.my

Study Locations

  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • University Malaya Medical Centre
        • Contact:
        • Sub-Investigator:
          • Nurafza Ahmad Hisham
        • Principal Investigator:
          • Ina I Shariffuddin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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 Names:
  • 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 Names:
  • Handgrip strength

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At recruitment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At recruitment
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.
Handgrip strength repeated within 1 month post IV iron administration preoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaya

Collaborators

Ministry of Health, Malaysia

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 18, 2020

Primary Completion (Anticipated)

March 31, 2021

Study Completion (Anticipated)

April 30, 2021

Study Registration Dates

First Submitted

November 11, 2020

First Submitted That Met QC Criteria

November 18, 2020

First Posted (Actual)

November 24, 2020

Study Record Updates

Last Update Posted (Actual)

November 24, 2020

Last Update Submitted That Met QC Criteria

November 18, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Anaemiahandgrip

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Study protocol, statistic analysis plan

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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