Leg EdemaETANCT04514939
Elevate to Alleviate Evidence Based Study
An observational study of Leg Edema and Venous; Return (Anomaly), run by University of Catanzaro at 1 site in Italy.
Trial summary
Venous return in the circulatory system of lower limbs results from the interaction of several mechanisms, and reflects the balance between blood inflow and outflow. Blood outflow improves during sleeping because of the lying position especially with leg elevation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leg Edema, Venous; Return (Anomaly), Leg Elevation
- What is being tested?
- Elevation of the legs during bed rest
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2020to 31 Aug 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 years and older
- All sexes
- Adult, Older adult
Study population: Unselected patients with a hospital stay of at least seven days will be recruited and random assigned to two groups of patients of the study.
Who may be able to join
- Every hospital inpatient with at least 7 hospital stay.
Who cannot join
- Patients with vascular or osteoarticular leg problems that affect or prevent leg elevation during rest.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Elevate to Alleviate - Evidence Based Nursing Study
Venous return in the circulatory system of lower limbs results from the interaction of several mechanisms, and reflects the balance between blood inflow and outflow. Blood outflow improves during sleeping because of the lying position especially with leg elevation. In fact, patients with chronic venous disease (CVD) improve leg symptoms in lying position and with leg elevation.
The aim of this study is to evaluate the level of comfort of hospital inpatients, without CVD, if they lie with a moderate leg elevation during hospital stay.
Read the detailed description
The venous system makes the blood return to the heart with low-pressure and slow-velocity flow, within the venous system. Venous return results from the interaction of diverse mechanisms, such a central pump (respiratory cycle and the heart), a pressure gradient, a peripheral venous muscular pump, and the veins valvular system. Therefore, the venous volume in the lower limb is the result of the interaction between these mechanisms and reflects the balance between blood inflow and outflow. Blood outflow improves during sleeping because of the lying position and, in this position, even more with leg elevation. In fact, it is known patients with chronic venous disease (CVD) improve leg symptoms in lying position and with leg elevation.
The aim of this study is to evaluate the level of comfort of hospital inpatients, without CVD, if they lie with a moderate leg elevation during hospital stay.
Unselected patients with a hospital stay of at least seven days will be recruited and random assigned to two groups of patients: Group A, that will lie in their hospital bed with a moderate leg elevation (between 15 and 30 degrees). Group B, that will lie in their hospital bed without leg elevation.
All patients will undergo echo duplex scanning of vascular system of lower limbs to exclude any vascular disease.
For every patient complete demographic and comorbidity data will be collected. Every single the day, the following parameters will be retrieved for each patient: ankle and calf diameters, heart rate, blood pressure, breath frequency, body temperature, leg heaviness (rating scale 1-10), perceived leg comfort (rating scale 1-10), hours of night sleep (number).
- Conditions
- Leg Edema, Venous; Return (Anomaly), Leg Elevation
- Being tested
- Elevation of the legs during bed rest
- Keywords
- venous returns, lower limbs, leg elevation
- Medical subject headings
- Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elevation of the legs during bed restOther
Patients of Group A will will lie in their hospital bed with a moderate leg elevation (between 15 and 30 degrees)
| Study group | Role | What they receive |
|---|---|---|
| Group A - Leg elevation | Patients will lie in their hospital bed with a moderate leg elevation (between 15 and 30 degrees) Receives: Other: Elevation of the legs during bed rest | |
| Group B- Non Leg elevation | Patients will lie in their hospital bed without leg elevation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ankle and calf diameters measurement
Every Morning Ankle and calf diameters will be measured in centimeters.
Measured: at 6 months
Legs heaviness evaluation
Every Morning Each patient will comunicate his/her perception of legs heaviness using a rating scale (1-10: 1 is absence of heaviness and 10 is high heaviness)
Measured: at 6 months
Perceived leg comfort evaluation
Every Morning Each patient will comunicate his/her perception of legs heaviness using a rating scale (1-10: 1 is minimum comfort and 10 is maximum comfort)
Measured: at 6 months
Hours of night sleep
Every Morning Each patient will comunicate the number of hours slept
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start1 Sep 2020 (estimated)
- Primary completion1 Mar 2021 (estimated)
- Study completion31 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Leg EdemaStudies of the same condition, open and under way.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Catanzaro
- Sponsor type
- University, hospital or other
- Collaborators
- University of Roma La Sapienza
- Responsible party
- Principal investigator, Prof. Raffaele Serra, MD, Ph.D., University of Catanzaro
- Investigators
- Nicola Ielapi, R.N., Principal investigator, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04514939
- Sponsor's protocol ID
- ER.ALL.2018.12
- Acronym
- ETA
- Status last verified
- Aug 2020
- First submitted
- 12 Aug 2020
- Last updated
- 17 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liaw MY, Wong MK. [The effects of leg elevation to reduce leg edema resulting from prolonged standing]. Taiwan Yi Xue Hui Za Zhi. 1989 Jun;88(6):630-4, 628. Chinese.
PubMed 2794965Sugisawa R, Unno N, Saito T, Yamamoto N, Inuzuka K, Tanaka H, Sano M, Katahashi K, Uranaka H, Marumo T, Konno H. Effects of Compression Stockings on Elevation of Leg Lymph Pumping Pressure and Improvement of Quality of Life in Healthy Female Volunteers: A Randomized Controlled Trial. Lymphat Res Biol. 2016 Jun;14(2):95-103. doi: 10.1089/lrb.2015.0045. Epub 2016 Jan 29.
PubMed 26824795
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elevate to Alleviate - Evidence Based Nursing Study
- ClinicalTrials.gov ID
- NCT04514939
- Acronym / sponsor ID
- ETA / ER.ALL.2018.12
- Conditions
- Leg Edema, Venous; Return (Anomaly), Leg Elevation
- Keywords
- venous returns, lower limbs, leg elevation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of CatanzaroUniversity, hospital or other
- Collaborators
- University of Roma La Sapienza
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 17 Aug 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.
Venous return in the circulatory system of lower limbs results from the interaction of several mechanisms, and reflects the balance between blood inflow and outflow. Blood outflow improves during sleeping because of the lying position especially with leg elevation. In fact, patients with chronic venous disease (CVD) improve leg symptoms in lying position and with leg elevation.
The aim of this study is to evaluate the level of comfort of hospital inpatients, without CVD, if they lie with a moderate leg elevation during hospital stay.
Detailed description
The venous system makes the blood return to the heart with low-pressure and slow-velocity flow, within the venous system. Venous return results from the interaction of diverse mechanisms, such a central pump (respiratory cycle and the heart), a pressure gradient, a peripheral venous muscular pump, and the veins valvular system. Therefore, the venous volume in the lower limb is the result of the interaction between these mechanisms and reflects the balance between blood inflow and outflow. Blood outflow improves during sleeping because of the lying position and, in this position, even more with leg elevation. In fact, it is known patients with chronic venous disease (CVD) improve leg symptoms in lying position and with leg elevation.
The aim of this study is to evaluate the level of comfort of hospital inpatients, without CVD, if they lie with a moderate leg elevation during hospital stay.
Unselected patients with a hospital stay of at least seven days will be recruited and random assigned to two groups of patients: Group A, that will lie in their hospital bed with a moderate leg elevation (between 15 and 30 degrees). Group B, that will lie in their hospital bed without leg elevation.
All patients will undergo echo duplex scanning of vascular system of lower limbs to exclude any vascular disease.
For every patient complete demographic and comorbidity data will be collected. Every single the day, the following parameters will be retrieved for each patient: ankle and calf diameters, heart rate, blood pressure, breath frequency, body temperature, leg heaviness (rating scale 1-10), perceived leg comfort (rating scale 1-10), hours of night sleep (number).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A - Leg elevation | – | Other: Elevation of the legs during bed restPatients will lie in their hospital bed with a moderate leg elevation (between 15 and 30 degrees) |
| Group B- Non Leg elevation | – | –Patients will lie in their hospital bed without leg elevation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Unselected patients with a hospital stay of at least seven days will be recruited and random assigned to two groups of patients of the study.
Key inclusion criteria (1 listed)
- Every hospital inpatient with at least 7 hospital stay.
Key exclusion criteria (1 listed)
- Patients with vascular or osteoarticular leg problems that affect or prevent leg elevation during rest.
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 |
|---|---|---|
| Elevation of the legs during bed restPatients of Group A will will lie in their hospital bed with a moderate leg elevation (between 15 and 30 degrees) | Other | Group A - Leg elevation |
Primary outcome
Ankle and calf diameters measurement
Time frame: at 6 months
Every Morning Ankle and calf diameters will be measured in centimeters.
Legs heaviness evaluation
Time frame: at 6 months
Every Morning Each patient will comunicate his/her perception of legs heaviness using a rating scale (1-10: 1 is absence of heaviness and 10 is high heaviness)
Perceived leg comfort evaluation
Time frame: at 6 months
Every Morning Each patient will comunicate his/her perception of legs heaviness using a rating scale (1-10: 1 is minimum comfort and 10 is maximum comfort)
Hours of night sleep
Time frame: at 6 months
Every Morning Each patient will comunicate the number of hours slept
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2020.
- Background: PubMed 2794965Liaw MY, Wong MK. [The effects of leg elevation to reduce leg edema resulting from prolonged standing]. Taiwan Yi Xue Hui Za Zhi. 1989 Jun;88(6):630-4, 628. Chinese.
- Background: PubMed 26824795Sugisawa R, Unno N, Saito T, Yamamoto N, Inuzuka K, Tanaka H, Sano M, Katahashi K, Uranaka H, Marumo T, Konno H. Effects of Compression Stockings on Elevation of Leg Lymph Pumping Pressure and Improvement of Quality of Life in Healthy Female Volunteers: A Randomized Controlled Trial. Lymphat Res Biol. 2016 Jun;14(2):95-103. doi: 10.1089/lrb.2015.0045. Epub 2016 Jan 29.
- Individual participant dataSharing planned: No
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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.
Nicola Ielapi, R.N. principal investigator
University of Roma La Sapienza
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 Leg Edema and Venous; Return (Anomaly), run by University of Catanzaro at 1 site in Italy.
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 1 inclusion and 1 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 17 Aug 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 Italy. 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 Raffaele Serra, M.D., Ph.D. (+3909613647380, rserra@unicz.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ankle and calf diameters measurement (time frame: at 6 months). The study lists 4 primary outcomes in all. 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 NCT04514939, which also lists 2 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 17 Aug 2020.