Elevate to Alleviate Evidence Based Study
- Conditions
- Leg ElevationLeg EdemaVenous; Return (Anomaly)
- Interventions
- Other: Elevation of the legs during bed rest
- Registration Number
- NCT04514939
- Lead Sponsor
- University of Catanzaro
- 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.
- 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).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- Every hospital inpatient with at least 7 hospital stay.
- Patients with vascular or osteoarticular leg problems that affect or prevent leg elevation during rest.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group A - Leg elevation Elevation of the legs during bed rest Patients will lie in their hospital bed with a moderate leg elevation (between 15 and 30 degrees)
- Primary Outcome Measures
Name Time Method Legs heaviness evaluation 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 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)
Ankle and calf diameters measurement at 6 months Every Morning Ankle and calf diameters will be measured in centimeters.
Hours of night sleep at 6 months Every Morning Each patient will comunicate the number of hours slept
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University Magna Graecia of Catanzaro
🇮🇹Catanzaro, Italy