AnemiaNCT04642521
Association Between Anaemia and Handgrip Strength in Female Planned for Major Surgery and the Effect of Intravenous Iron on Handgrip Strength
An observational study of Anemia and Iron-deficiency, run by University of Malaya at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anemia, Iron-deficiency, Patient Blood Management
- What is being tested?
- Jamar hydraulic hand dynamometer
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 65 participants
- Where
- 1 siteMalaysia
- Study dates
- 18 Nov 2020to 30 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Female participants of ProPBM study who are planned for major elective surgery, both anaemic and non anaemic patients are included
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
University Malaya Medical Centre
Kuala Lumpur, 59100
Nurafza Ahmad Hisham, +60124100029, nurafza@gmail.com
Nurafza Ahmad Hisham
About this study
Official title: 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.
Read the 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.
- Being tested
- Jamar hydraulic hand dynamometer
- Keywords
- handgrip strength, intravenous iron
- Medical subject headings
- Anemia, Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jamar hydraulic hand dynamometerDevice
Also called Handgrip strength
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.
| Study group | Role | What they receive |
|---|---|---|
| Iron deficiency anaemia | Preoperatively, participants who are iron deficient with or without anaemia will receive intravenous iron (Monofer) as per ProPBM protocol. Receives: Device: Jamar hydraulic hand dynamometer | |
| No iron deficiency anaemia | Patient in this group will not be given intravenous iron. Receives: Device: Jamar hydraulic hand dynamometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At recruitment
Secondary outcomes (2)
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.
Measured: At recruitment
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.
Measured: Handgrip strength repeated within 1 month post IV iron administration preoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2020
- Study start18 Nov 2020 (estimated)
- Primary completion31 Mar 2021 (estimated)
- Study completion30 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Malaysia
- Responsible party
- Sponsor
- Investigators
- Ina I Shariffuddin, Principal investigator, Ministry of Health, Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04642521
- Sponsor's protocol ID
- Anaemiahandgrip
- Status last verified
- Nov 2020
- First submitted
- 11 Nov 2020
- Last updated
- 24 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study protocol, statistic analysis plan
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.
PubMed 21624928Joosten 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.
PubMed 27543049Santos 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.
PubMed 30628133
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anaemia and Handgrip Strength, a Prospective Observatonal Study Amongst Female Population Planned for Major Elective Surgery
- ClinicalTrials.gov ID
- NCT04642521
- Acronym / sponsor ID
- Anaemiahandgrip
- Keywords
- handgrip strength, intravenous iron
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Collaborators
- Ministry of Health, Malaysia
- Study start
- 18 Nov 2020 (estimated)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 24 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iron deficiency anaemia | – | Device: Jamar hydraulic hand dynamometerPreoperatively, participants who are iron deficient with or without anaemia will receive intravenous iron (Monofer) as per ProPBM protocol. |
| No iron deficiency anaemia | – | Device: Jamar hydraulic hand dynamometerPatient in this group will not be given intravenous iron. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Female participants of ProPBM study who are planned for major elective surgery, both anaemic and non anaemic patients are included
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jamar hydraulic hand dynamometerAlso: Handgrip strengthThe 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. | Device | Iron deficiency anaemia, No iron deficiency anaemia |
Primary outcome
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.
2 secondary outcomes
Association between handgrip strength and iron status within female participants of ProPBM study
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
- Background: PubMed 21624928Roberts 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.
- Background: PubMed 27543049Joosten 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.
- Results publication: PubMed 30628133Santos 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.
- Individual participant dataSharing planned: No. Study protocol, statistic analysis plan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ina I Shariffuddin principal investigator
Ministry of Health, Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia and Iron-deficiency, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact University of Malaya Medical Centre Jalan Universiti (+60379494422, ummc@ummc.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between handgrip strength and haemoglobin status within female participants of ProPBM study (time frame: At recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04642521, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2020.