Elevate to Alleviate Evidence Based Study

NCT04514939 | Unknown DMC

• 1 other identifier: ER.ALL.2018.12
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Leg Edema; Venous; Return (Anomaly); Leg Elevation

Keywords

venous returns; lower limbs; leg elevation

Outcome Measures

Primary Outcomes (4)

• Ankle and calf diameters measurement

  Every Morning Ankle and calf diameters will be measured in centimeters.

  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)

  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)

  at 6 months

• Hours of night sleep

  Every Morning Each patient will comunicate the number of hours slept

  at 6 months

Study Arms (2)

Group A - Leg elevation

Patients will lie in their hospital bed with a moderate leg elevation (between 15 and 30 degrees)

Other: Elevation of the legs during bed rest

Group B- Non Leg elevation

Patients will lie in their hospital bed without leg elevation

Interventions

Elevation of the legs during bed rest OTHER

Patients of Group A will will lie in their hospital bed with a moderate leg elevation (between 15 and 30 degrees)

Group A - Leg elevation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Every hospital inpatient with at least 7 hospital stay.

You may not qualify if:

• Patients with vascular or osteoarticular leg problems that affect or prevent leg elevation during rest.

Sponsors & Collaborators

• University of Catanzaro: lead
• University of Roma La Sapienza: collaborator

Study Sites (1)

University Magna Graecia of Catanzaro

Catanzaro, 88100, Italy

Location

Related Publications (2)

• 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.

  PMID: 2794965 BACKGROUND

• Sugisawa 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.

  PMID: 26824795 BACKGROUND

MeSH Terms

Conditions

Congenital Abnormalities

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Nicola Ielapi, R.N.

  University of Roma La Sapienza

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raffaele Serra, M.D., Ph.D.

CONTACT

+3909613647380; rserra@unicz.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Vascular Surgery

Study Record Dates

• First Submitted: August 12, 2020
• First Posted: August 17, 2020
• Study Start: September 1, 2020
• Primary Completion: March 1, 2021
• Study Completion: August 31, 2021
• Last Updated: August 17, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)