The purpose of this study is to investigate the acute effects of gluteal and hamstring ES on femoral artery blood flow, skin vascular function and energy expenditure using ES shorts as a simplistic non-invasive method of ES.
ID
Source
Brief title
Condition
- Spinal cord and nerve root disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Profunda femoral artery blood flow: The profunda is a deep artery of the thigh
that travels more posteriorly than the rest of the femoral artery to supply the
gluteal and hamstring muscles. Using a 2-dimensional echo Doppler ultrasound
device, scans of the prounda femoral artery will be collected to determine
artery diameter and blood flow (BF). Measurements will be performed at baseline
(rest), every 15 minutes during the 2-hour stimulation protocol 30 minutes and
1-hour post stimulation in the intervention leg. Measurements in the
unstimulated control leg will be performed pre and post stimulation. All
measurements will be recorded for later offline analysis using custom-designed
edge detection and wall tracking software
Skin vascular function (CVC): Cutaneous blood flow will be measured on the
gluteal/thigh area using laser-Doppler flowmetry (Periflux 5001, Sweden).
Measurements will be performed pre, during and post stimulation in the control
and intervention legs. Local skin temperature will be controlled at 33 °C using
local heating units (Perimed 455, Sweden). Cutaneous vascular conductance (CVC)
will be calculated as flux (AU) divided by MAP (mmHg).
Secondary outcome
Energy Expenditure: Participants will wear a facemask and energy expenditure
will be calculated based on oxygen consumption measured by open-circuit
spirometry (COSMED K4b2, Rome, Italy). Mean energy expenditure without ES will
be calculated during the first 10 minutes of the resting period before the
start of ES. Mean energy expenditure during ES will be calculated over each
block of ES during the 2-hour protocol.
Background summary
Following a spinal cord injury (SCI) there are significant changes in
peripheral vascular structure and function. A decrease in conduit artery
diameter (de Groot et al., 2004; de Groot et al., 2006a; de Groot et al.,
2006b), increased vascular resistance (Hopman et al., 2002), reduced
capillarization (Chilibeck et al., 1999) and impaired cutaneous
microcirculation (Nicotra et al., 2004; Van Duijnhoven et al., 2009) are
typically observed in the paralysed, inactive limbs. Collectively, such
vascular changes are associated with increased risk of cardiovascular related
mortality and likely contribute to frequently reported pathologies such as skin
breakdown lesions (Deitrick et al., 2007) and poor wound healing. Furthermore,
individuals with a SCI experience changes in body composition including an
increase in adipose tissue and a significant loss in muscle mass. These changes
importantly contribute to reductions in daily energy expenditure and increase
the risk of obesity among individuals with SCI.
Regular muscular contractions act as a pumping mechanism to facilitate the
movement of blood through the vascular network and prevent venous pooling in
the lower limbs. Due to motor paralysis below the lesion, this blood pumping
mechanism is no longer active. Electro-stimulation (ES) induced muscle
activation is an alternative method to overcome the loss of regular voluntary
muscular contractions and improve vascular health through increased regional
blood flow. Indeed, various methods of ES in SCI have resulted in improved
transcutaneous oxygen levels (Smit et al., 2013b; Wu et al., 2013), increase
femoral artery diameters (Thijssen et al., 2006) and decreased peripheral
vascular resistance (Hopman et al., 2002). Additionally, the use of ES
increases circulating blood volume to the normally inactive limbs, thus
increasing oxygen demand of the working muscles and potentially increasing
energy expenditure. However, a majority of ES methods currently used require
specialist facilities and trained staff, are labour intensive and impractical.
Specially fabricated clothing with built in electrodes may be an alternative
way to administer ES without the expense and practicality issues associated
with other methods of ES. For example, Smit et al have previously used
partially elasticated lycra shorts with embedded surface electrodes as a way of
activating the gluteal and hamstring muscles in persons with SCI. They found
that an acute bout of ES lead to significant pressure relief in areas at risk
of skin breakdown lesions (Smit et al., 2013a). Furthermore, the participants
involved in the study stated that they would be satisfied wearing the shorts on
a daily basis providing they helped ameliorate the risk factors associated with
pressure ulcers. Considering that ES induced gluteal and hamstring activation
has previously been shown to increase (sub)cutaneous blood flow and oxygenation
(Smit et al., 2013b), other areas of the deeper vasculature may also be subject
to increases in blood flow. To our knowledge, no study has measured conduit
artery blood flow during an acute bout of ES in SCI individuals.
Study objective
The purpose of this study is to investigate the acute effects of gluteal and
hamstring ES on femoral artery blood flow, skin vascular function and energy
expenditure using ES shorts as a simplistic non-invasive method of ES.
Study design
Ten individuals with a spinal cord injury will be recruited to take part in
this study. The ES intervention consists of a portable functional electrical
stimulation box (Neuropro, BerkelBikes, Sint-Michielsgestel, The Netherlands)
connected to a wearable garment (shorts), which will safely house the wires
from the stimulator. Two built-in surface electrodes will be placed over the
upper part of the gluteal muscles and 1 over the hamstring muscles of 1 leg.
The surface electrodes (with conductive gel) are connected to elastic
conductors, guided through the side of the shorts to the front, ensuring the
participant does not sit on the wires. Stimulation will be delivered
biphasically at 50Hz to induce a (visible) tetanic contraction. The current
amplitude will be adjusted for each subject by increasing the current amplitude
in steps of 5mA to a point that doesn*t cause discomfort or excessive muscle
contractions. The stimulation protocol will consist of 3-minute blocks of
gluteal and hamstring activation for a total of 2 hours. A duty cycle of 1s
stimulation and 4s off will be used during the 3 minutes followed by a rest
period of 16 minutes. The average current amplitude using this stimulation
protocol has been 94±13 mA, ranging from 70 to 115 mA, in our previous studies.
The individuals will remain in a supine position for the duration of the
protocol.
Intervention
The ES intervention consists of a portable functional electrical stimulation
box (Neuropro, BerkelBikes, Sint-Michielsgestel, The Netherlands) connected to
a wearable garment (shorts), which will safely house the wires from the
stimulator. Two built-in surface electrodes will be placed over the upper part
of the gluteal muscles and 1 over the hamstring muscles of 1 leg. The surface
electrodes (with conductive gel) are connected to elastic conductors, guided
through the side of the shorts to the front, ensuring the participant does not
sit on the wires. Stimulation will be delivered biphasically at 50Hz to induce
a (visible) tetanic contraction. The current amplitude will be adjusted for
each subject by increasing the current amplitude in steps of 5mA to a point
that doesn*t cause discomfort or excessive muscle contractions. The stimulation
protocol will consist of 3-minute blocks of gluteal and hamstring activation
for a total of 2 hours. A duty cycle of 1s stimulation and 4s off will be used
during the 3 minutes followed by a rest period of 16 minutes. The average
current amplitude using this stimulation protocol has been 94±13 mA, ranging
from 70 to 115 mA, in our previous studies. The individuals will remain in a
supine position for the duration of the protocol.
Study burden and risks
The paralyzed buttock and leg muscles of the participants will be activated,
which does not evoke a marked burden or any discomfort. A minor risk is that
the skin under the electrodes may be lightly irritated, but this will disappear
quickly. The experiments will take 3 hours in total.
Van der Boechortstraat 9
Amsterdam 1081BT
NL
Van der Boechortstraat 9
Amsterdam 1081BT
NL
Listed location countries
Age
Inclusion criteria
* Age 18-75 years
* ASIA Impairment Scale A-B with intact reflex arcs (i.e. spastic paralysis)
* Lesion level * Time since injury >6 months
* Able to tolerate stimulation (i.e. no autonomic dysreflexia induced)
Exclusion criteria
* An intolerance to or contraindication for electrical stimulation
* A history of severe autonomic dysreflexia or severe cognitive or communicative disorders
* A flaccid paralysis or areflexia
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL59052.048.16 |