Effectiveness of Passive Mobilization on Vascular Function of Bedridden Oldest Old
Phase: NA
Conditions: Endothelial Dysfunction, Aging, Bed Rest
Sponsor: Universita di Verona

PASSIVE MOBILIZATION AND VASCULAR FUNCTION 
ClinicalTrials.gov Identifier: NCT03087643 
Date of the document: 14.06.2016 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

OPINION REQUEST TO THE INDEPENDENT ETHICAL 
COMMITTEE OF THE NEUROLOGICAL, 
NEUROPSYCHOLOGICAL, MORPHOLOGICAL, AND 
MOVEMENT SCIENCES DEPARTMENT FOR THE 
APPROVATION OF STUDIES AND CLINICAL 
EXPERIMENTATION 
 
 
TO THE ETHICAL COMMITTEE 
 
 
I, the undersigned, Dr. Massimo Venturelli 
Position: Grant Holder 
Section: Movement Sciences 
Location: Via Casorati, 37134 Verona 
Telephone number: 3474022019 
E-mail: massimo.venturelli@univr.it 
 
 
REQUEST 
 
the ethical opinion about the study/experimentation 
 
 
“EFFECTS AND COUNTERMEASURES ASSOCIATED TO BED REST IN THE 
ELDERLY” 
 
 

1) STRUCTURE OF THE DEPARTMENT CARRYING OUT THE STUDY: 
 
- 
Section of Movement Sciences 
- 
“Mons. Arrigo Mazzali Foundation”, Mantova 
 
The undersigned guarantees: 
- 
The competence and adequacy of the personnel; 
- 
The eligibility and conformity of the available instrumentation to the current laws 
 
2) NAME AND SURNAME OF THE SCIENTIFIC COORDINATOR OF THE 
EXPERIMENTATION AND OF THOSE AUTHORIZED  
 
Scientific Manager: Prof. Federico Schena 
Researcher: Dr. Massimo Venturelli 
Health Director of Mons. Mazzali Onlus Foundation: Dr. Renato Bottura 
Medical Doctors: Dr. Renato Scarsini; Dr. Ettore Muti; Dr. Andrea Storti; Dr. Giampaolo 
Moretti. 
 
 

3) STUDY BACKGROUND 
 
Bed rest has historically been used as a therapy for the control of several chronic 
diseases having a high incidence in the elderly population (7, 14, 19). It is also a common step 
in the process of physical activity reduction leading up to death. Bed rest, induced by both 
intrinsic and extrinsic factors related to ageing, has catastrophic effects on health, triggering a 
series of comorbidities that aggravate the physical decline of the elderly (5, 13, 16, 17). The 
harmful consequences of immobility affect the musculoskeletal, cardiopulmonary, and 
neurological systems, causing muscular atrophy, hypotension, thrombosis, vascular 
dysfunction and decubitus ulcers (5, 14, 15, 17). 
 
For example, Paul Rousseau (14) described how the complications of bed rest trigger a 
spiral of events that, starting with immobility, causes a multi-organ deconditioning followed 
by a further worsening of the disability that originally caused bed rest. Other studies reported 
how immobility causes a decrease in cardiac output, heart rate, plasma volume, and a reduction 
in all parameters of pulmonary function (ventilation, tidal volume, maximum ventilatory 
capacity), leading to a reduced arterial oxygen saturation. Other consequences of bed rest are 
a reduction in resting metabolism and appetite besides a negative nitrogen balance. 
 
Bed rest in the elderly is associated to a series of dysfunctions affecting the 
cardiovascular system, central and peripheric haemodynamic. Blood stasis in the large 
capacitance vessels, together with a reduced blood flow, are cofactors in the elevated risk of 
having venous thromboembolism (VTE) and decubitus ulcers (5). In order to diminish some 
of the negative effects of bed rest, passive mobilization of the patient is nowadays a 
consolidated practice (14), but several studies reported greater improvements in the vascular 
functionality of chronically immobilized patients caused by spinal cord injury and/or stroke 
after being treated with Functional Electrical Stimulation (FES) (3, 6, 9, 12). This type of 
therapeutic approach has been shown to be effective, incrementing the femoral artery diameter, 
improving resting blood flow and increasing flow mediated vasodilation (FMD) with no 
particular contraindication or low treatment tolerance being reported in past studies. Moreover, 
the application of FES had an evident physiological effect on blood flow that was also 
accompanied by a significant reduction in decubitus ulcers (18) and other complications linked 
to immobilization (20). 
 
With a different approach, some studies have also verified how specific interventions 
may prevent and/or reduce immobilization-induced vascular dysfunctions in the bed resting 
elderly population. The use of anti-decubitus mattresses, the correct positioning and passive 
physical therapies, have all been successfully utilized in the prevention of decubitus ulcers. The 

use of supports that allow a semi-recumbent position and the elastic compression of the lower 
limbs are effective therapies to reduce the probability of getting VTE and reduce the pooling 
of blood in the lower extremities (14). 
Other studies (1, 2, 11, 12) have also shown how electrostimulation may be an effective 
intervention in the cure and prevention of the dysfunctions associated to bed rest. Broderick 
and colleagues (2) demonstrated that electrostimulation of the calf muscle improves venous 
return and prevents blood stasis in the legs during 4 hours of forced immobilization. 
Furthermore, bed rest studies that simulate space microgravity proved that electrostimulation 
is an effective method to prevent the physiological consequences of immobilization (4). 
 
 
At present, no study has shown if electrostimulation can diminish the negative effects 
of bed rest in the vascular functions. For this reason, the objective of this study will be to verify 
if electrostimulation can improve and/or reduce the negative effects of immobility on the 
vascular functions of the lower limbs in the bed resting elderly. 
METHODS 
Inclusion criteria: bed rest and walking inability for at least 6 months and no more than 2 
years, age > 70 years. 
Exclusion criteria: considering the type of intervention and the evaluations that will be 
performed, we will not include subjects presenting: 
• Myocardial infarction (in the last 6 months) 
• Symptomatic aortic stenosis 
• Acute pulmonary embolism or pulmonary infarction 
• Acute non-cardiac pathology that may be aggravated by electrostimulation (i.e. 
infection, renal insufficiency) 
• Left coronary stenosis or equivalent 
• Abnormal electrolytes blood concentration  
• Atrial fibrillation with uncontrolled ventricular rate 
• Cardiac pacemaker and/or defibrillator 
• Use of anticoagulant drugs 
• Stroke with consequent hemiparesis 
 
The specialized geriatric medical team of the “Fondazione Mazzali di Mantova” will select 20 
non-self-sufficient elders (age > 70 years), living temporarily in the nursing home of the 
foundation. The family members and/or legal caregivers of the residents will receive detailed 
information about the measurements and the purpose of the study. All the subjects will receive 

an electrostimulation treatment on one of the lower limbs, while the contralateral one will only 
be evaluated but will not receive any treatment, acting as a control. 
All the researchers and health care personnel participating in the study declared that they do 
not present any conflict of interest in the practice of their functions. 
 
All the subjects will be evaluated through tests in order to determine: 
• Anthropometric measures of the limbs 
• Vascular functionality of the lower limbs through Echo Color Doppler with the Flow 
Mediated Dilation (FMD) technique with the objective to measure the residual 
vasodilatory capacity. 
• The measurements will be repeated after an 8 months treatment, based on 30 minutes 
of electrostimulation, 5 days per week. 
• The electrostimulation treatment will take place at the subject bed place for a duration 
of 30 minutes. The stimulation will be carried out with a professional stimulator 
(Genesy 1200 pro, Globus Italia Treviso). The electrodes will be placed in a balanced 
manner following the guidelines delineated by Maffiuletti et al. (12) on the lower 
right or left limb. As outlined in previous studies (2, 10-12), the intensity and the 
characteristics of the electric current used for the treatment (capillarization 
programme Genesy 1200 pro, Globus Italia) will be modulated based upon the subject 
tolerance. 
• Treatment suspension criteria: the treatment will be suspended in case it is not 
tolerated by the patient, and/or it causes an altered psychophysical state that 
diminishes the residual quality of life.  
STATISTICAL PROCEDURES 
A two-way ANOVA for repeated measures will be used to establish differences between 
groups and limbs. A Bonferroni post-hoc test will be used, when appropriate, to 
determine group differences. 
Mantova, 14/06/2016, The applicant 
 
 

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