Passive Mobilization and Vascular Function

Study Overview
=================
Brief Summary
-----------------
With aging, vascular function (VF) declines. Inactivity and sedentary life style have been shown to contribute to the worsening of VF. Furthermore, bed rest, a condition commonly used for the management of many chronic conditions, has been proven to lead to even more deleterious consequences, including VF decline. This study evaluates the effect of passive mobilization of the lower limbs on VF in bedridden oldest-old. Half of the participants will undergo passive mobilization treatment in addition to standard therapies, while the other half will receive only standard therapies. We hypothesize that passive mobilization may improve nitric oxide (NO)-mediated endothelial function.

Detailed Description
-----------------
Normally, cardiovascular function declines with age. Furthermore, cardiovascular function declines with immobility, promoting other adverse effects such as postural hypotension, impaired cardiac function, and thrombogenic events. Bed rest, a condition normally used in the management of many chronic pathologies in elderly people, leads to significant functional decline, reduction in physiologic reserve of most of the organ systems, including further cardiovascular decline. Fortunately, several studies have suggested interventions that may counteract immobility-induced cardiovascular dysfunction and ensure beneficial adaptations in the aging population. For example, passive mobilization of the limbs has been shown to improve cardiovascular function in bedridden oldest-old. However, the effect of passive mobilization on NO-mediated endothelial function have not been studied yet. Thus, the main aim of the study is to determine whether passive mobilization is an effective strategy to counteract endothelial dysfunction in bedridden oldest-old. For this purpose, bedridden individuals will be recruited and randomly assigned to two groups: one group will undergo passive mobilization treatment (PM) in addition to standard therapies, the other group (CTRL) will undergo standard therapies only. On the basis of preliminary data on a subgroup of ten participants, a sample of eighteen individuals will be allocated in each group so to reach a statistical power >0.80 and an alpha <0.05. The PM treatment will include knee flexion-extension and it will be performed for 30 minutes, 2 times a day, 5 days a week for 4 weeks. Before, after the 4-week treatment, and 1 month after the end of the treatment NO-mediated endothelial function of all participants will be evaluated by means of flow-mediated dilation and passive limb movement tests.

Official Title
-----------------
Effectiveness of Passive Mobilization on Vascular Function of Bedridden Oldest Old

Conditions
-----------------
Endothelial Dysfunction, Aging, Bed Rest

Intervention / Treatment
-----------------
* Other: Passive mobilization - PM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Bedridden Exclusion Criteria: Neurodegenerative disease (i.e.Parkinson's disease, Alzheimer's disease) Heart failure Organ transplantation Liver failure Kidney failure Hemorrhage Neuromuscular diseases

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 110 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Passive mobilization - PM<br>Participants will receive 2 times a day, for 5 days a week 30 minutes of passive leg movement treatment including knee flexo-extension in addition to their standard therapies. | Other: Passive mobilization - PM<br> <br> |
| No Intervention: Control group - ctrl<br>Participants will receive ther standard therapies. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Delta Peak Blood Flow During sPLM | Through the use of single Passive Limb Movement (sPLM) test, investigators assessed PLM-induced hyperemia [ delta peak; ml/min] in the common femoral artery of both, right and left legs, during and 60 second after a single passive knee flexion and extension lasting 1 second. | PRE and POST 4 weeks of treatment | 
| Change of % FMD | Through the use of Flow-mediated Dilation (FMD) test , investigators assessed the dilation capacity of right the brachial artery (%FMD) during two minutes following 5-minute ischemic occlusion. | PRE and POST 4 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Total Hemoglobin | Total hemoglobin [uM] in both, right and left vastus lateralis, was assessed by means of Near-infrared Spectroscopy [NIRS] during the sPLM test. | PRE and POST 4 weeks of treatment | 
| Change of Range of Motion | Assessment of the passive force/joint angle relationship during knee passive mobilization | PRE and POST 4 weeks of treatment | 
| Change of Thickness of Vastus Lateralis | Evaluation of the architectural parameters (fascicle length, pinnation angle, and muscle thickness) of the vastus lateralis muscle by ultrasound | PRE and POST 4 weeks of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Flow-mediated dilation, Passive limb movement