Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ministry of Health, Malaysia | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iron deficiency anaemia | Preoperatively, participants who are iron deficient with or without anaemia will receive intravenous iron (Monofer) as per ProPBM protocol. |
| |
| No iron deficiency anaemia | Patient in this group will not be given intravenous iron. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Female population
Female participants of ProPBM study who are planned for major elective surgery, both anaemic and non anaemic patients are included
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| University of Malaya Medical Centre Jalan Universiti | Contact | +60379494422 | ummc@ummc.edu.my |
| Name | Affiliation | Role |
|---|---|---|
| Ina I Shariffuddin | Ministry of Health, Malaysia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Malaya Medical Centre | Kuala Lumpur | 59100 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21624928 | Background | 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. | |
| 27543049 | 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. |
Not provided
Not provided
Study protocol, statistic analysis plan
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| 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 |
| 30628133 | Result | 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. |
| ID | Term |
|---|---|
| D000740 | Anemia |
| D018798 | Anemia, Iron-Deficiency |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000747 | Anemia, Hypochromic |
| D000090463 | Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided