Assessment of Vasomotion of People With Spinal Cord Injury

Spinal Cord Injuries Clinical Trial

Official title:

Assessment of Vasomotion of People With Spinal Cord Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04215939
• Other study ID #: 9. Vasomotion & spinal
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: July 25, 2020

Study information

• Verified date: November 2020
• Source: University of Thessaly
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Spinal cord injury (SCI), causes loss of supra-spinal control of the sympathetic nervous system and in some cases loss of sensation. As a result, people with SCI have impaired thermoregulatory system and the consequence of this thermoregulatory dysfunction, is that they cannot respond to the environmental changes. All the above lead to dysregulation in vasomotor tone, skeletal muscle shivering and sweating dysfunction. It is well known that skin plays an important role in regulating body temperature and regulates interactions between the environment and human body. A previous study in people with incomplete SCI showed that there are no differences in core temperature between patients with different level of mobility and sensation and different level of lesion, but there are significant differences in skin temperature. As mentioned above people with SCI have an impaired thermoregulatory capacity due to sudomotor and vasomotor dysfunction and that leads to greater thermal strain during rest and exercise when they expose to hot conditions. A previous study that performed exercise in people with SCI, highlights the fact that because of the impaired evaporative heat loss during exercise in hot conditions, they are in great risk. Because of this risk they propose different cooling strategies that promote evaporation such as fans and water spraying. It is therefore important to observe the thermoregulatory function (vasomotion and sudomotor) in people with SCI when they are exposed to different environments (cold, neutral and warm).

Description:

The participants will visit the laboratory three times. At each time the environmental chamber will simulate a different environment in a random order for each participant. The three different environments will be as follow: 1. Cold environment 15-17°C and 40-50% relative humidity 2. Thermoneutral environment 22-24°C and 40-50% relative humidity 3. Warm environment 33-35°C and 40-50% relative humidity The participants will stay in a sited position for 20 minutes in order to collect baseline data and to allow to their blood flow and body temperature adapt to the exposing environmental condition each time. Immediately after the baseline period the participants will immerse their left hand and foot in warm water (34-36°C) for 5 minutes for a consistent starting (hand and foot) temperature. Following that participants will immerse their hand and foot in cold water (8°C) for 40 minutes. This procedure will be repeated in every measurement and it will only change the environment. Anthropometric data [self-reported age, self-reported body stature and body mass (DXA, Lunar, GE Healthcare Boston, Massachusetts, U.S)] will be collecting at the beginning of the first measurement. Medical history of all the participants will be recording. During the study, continuous heart rate (Polar Team2. Polar Electro Oy, Kempele, Finland), core temperature (telemetric capsules BodyCap, Caen, France), mean skin temperature (wireless thermistors iButtons type DS1921H, Maxim/Dallas Semiconductor Corp., USA), finger temperature ((Smartreader 8 Plus, ACR, Vancouver, Canada), skin blood flow and sweat rate data (laser Doppler flow-meter PeriFlux System 5010, function unit; Perimed, Stockholm, Sweden and PeriFlux System 4002, master unit, satellite unit; Perimed, Stockholm, Sweden) will be collecting. Blood pressure will also be monitoring every 10 minutes with an automatic sphygmomanometer (Omron Healthcare M6 comfort, Japan). Skin temperature data will be collecting from four sites (chest, arm, thigh, and leg) and will be expressed as mean skin temperature according to the formula of Ramanathan (Tsk = [0.3(chest + arm) + 0.2(thigh + leg)]. Questionnaires (thermal sensation scale: -3 = cold; +3 = hot) will be used to assess participants' thermal comfort/sensation and pain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 25, 2020
• Est. primary completion date: July 25, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• People with spinal cord injury below thoracic spine 6, at least six months after the injury.
• Healthy adult participants, non-smokers, no disease and/or taking medicines

Exclusion Criteria:

• People under the age of 18;
• People taking any medicines that affect vasomotion (e.g. for hypertension, thrombosis, etc.)
• People with other chronic diseases (e.g. diabetes)

Related Conditions & MeSH terms

• Paraplegia
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Behavioral:
• Cold environment participants with spinal cord injury
In a cold environment (15-17°C and 40-50% relative humidity), participants will stay in a sited position for 20 minutes in order to collect baseline data and to allow their blood flow and body temperature adapt to the exposing environmental condition. Immediately after the baseline period participants will immerse their left hand and foot in warm water (34-36°C) for five minutes for a consistent starting (hand and foot) temperature. Following that participants will immerse their hand and foot in cold water (8°C) for 40 minutes.
• Thermoneutral environment participants with spinal cord injury
In a thermoneutral environment (22-24°C and 40-50% relative humidity), participants will stay in a sited position for 20 minutes in order to collect baseline data and to allow their blood flow and body temperature adapt to the exposing environmental condition. Immediately after the baseline period participants will immerse their left hand and foot in warm water (34-36°C) for five minutes for a consistent starting (hand and foot) temperature. Following that participants will immerse their hand and foot in cold water (8°C) for 40 minutes.
• Warm environment participants with spinal cord injury
In a warm environment (33-35°C and 40-50% relative humidity), participants will stay in a sited position for 20 minutes in order to collect baseline data and to allow their blood flow and body temperature adapt to the exposing environmental condition. Immediately after the baseline period participants will immerse their left hand and foot in warm water (34-36°C) for five minutes for a consistent starting (hand and foot) temperature. Following that participants will immerse their hand and foot in cold water (8°C) for 40 minutes.
• Cold environment healthy male participants
In a cold environment (15-17°C and 40-50% relative humidity), participants will stay in a sited position for 20 minutes in order to collect baseline data and to allow their blood flow and body temperature adapt to the exposing environmental condition. Immediately after the baseline period participants will immerse their left hand and foot in warm water (34-36°C) for five minutes for a consistent starting (hand and foot) temperature. Following that participants will immerse their hand and foot in cold water (8°C) for 40 minutes.
• Thermoneutral environment healthy male participants
In a thermoneutral environment (22-24°C and 40-50% relative humidity), participants will stay in a sited position for 20 minutes in order to collect baseline data and to allow their blood flow and body temperature adapt to the exposing environmental condition. Immediately after the baseline period participants will immerse their left hand and foot in warm water (34-36°C) for five minutes for a consistent starting (hand and foot) temperature. Following that participants will immerse their hand and foot in cold water (8°C) for 40 minutes.
• Warm environment healthy male participants
In a warm environment (33-35°C and 40-50% relative humidity), participants will stay in a sited position for 20 minutes in order to collect baseline data and to allow their blood flow and body temperature adapt to the exposing environmental condition. Immediately after the baseline period participants will immerse their left hand and foot in warm water (34-36°C) for five minutes for a consistent starting (hand and foot) temperature. Following that participants will immerse their hand and foot in cold water (8°C) for 40 minutes.
• Cold environment healthy female participants
In a cold environment (15-17°C and 40-50% relative humidity), participants will stay in a sited position for 20 minutes in order to collect baseline data and to allow their blood flow and body temperature adapt to the exposing environmental condition. Immediately after the baseline period participants will immerse their left hand and foot in warm water (34-36°C) for five minutes for a consistent starting (hand and foot) temperature. Following that participants will immerse their hand and foot in cold water (8°C) for 40 minutes.
• Thermoneutral environment healthy female participants
In a thermoneutral environment (22-24°C and 40-50% relative humidity), participants will stay in a sited position for 20 minutes in order to collect baseline data and to allow their blood flow and body temperature adapt to the exposing environmental condition. Immediately after the baseline period participants will immerse their left hand and foot in warm water (34-36°C) for five minutes for a consistent starting (hand and foot) temperature. Following that participants will immerse their hand and foot in cold water (8°C) for 40 minutes.
• Warm environment healthy female participants
In a warm environment (33-35°C and 40-50% relative humidity), participants will stay in a sited position for 20 minutes in order to collect baseline data and to allow their blood flow and body temperature adapt to the exposing environmental condition. Immediately after the baseline period participants will immerse their left hand and foot in warm water (34-36°C) for five minutes for a consistent starting (hand and foot) temperature. Following that participants will immerse their hand and foot in cold water (8°C) for 40 minutes.

Locations

Country	Name	City	State
Greece	FAME Lab, Department of Exercise Science, University of Thessaly	Tríkala	Thessaly

Sponsors (2)

Lead Sponsor	Collaborator
Petros Dinas	European Commission

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate	Heart rate will be continuously monitored using a Polar Team system (Polar® Team 2, Polar Electro Oy, Kempele, Finland	1 hour and 5 minutes
Primary	Heart rate variability	Heart rate variability will be continuously monitored using a Polar Team system (Polar® Team 2, Polar Electro Oy, Kempele, Finland	1 hour and 5 minutes
Primary	Skin temperature	Skin temperature (chest, arm, thigh, and leg) will be continuously monitored using iButton sensors type DS1921 H, Maxim/Dallas Semiconductor Corp., USA.	1 hour and 5 minutes
Primary	Finger temperature	Finger temperature will be monitored throughout baseline and water immersion at 8-s intervals using a data logger (Smartreader 8 Plus, ACR, Vancouver, Canada) interfacing with a computer to allow for their continuous monitoring by the investigators.	1 hour and 5 minutes
Primary	Body core temperature	Core body temperature will be assessed using telemetric capsules (e-Celsius, BodyCap, Caen, France) that we will give to the participants to ingest prior to the measurement.	1 hour and 5 minutes
Primary	Skin blood flow	Skin blood flow will be monitored via laser Doppler flowmeter (PeriFlux System 5010, function unit; Perimed, Stockholm, Sweden and PeriFlux System 4002, master unit, satellite unit; Perimed, Stockholm, Sweden)	1 hour and 5 minutes
Primary	Change of blood pressure	Blood pressure will be monitored every 10 minutes with an automatic sphygmomanometer (Omron Healthcare M6 comfort, Japan)	Change from baseline blood pressure at 10th, 20th, 30th, 40th, 50th and 65th minute.
Primary	Sweat rate	Sweat rate will be measured using a 5.0-cm2 ventilated capsule placed over the forehead and the gastrocnemius. Anhydrous compressed air will be passing through the capsule and over the skin surface (Brooks 5850, mass flow controller, Emerson Electric, Hetfield, PA, USA). The vapor density of the effluent air will be calculating from the relative humidity and temperature measured using the Omega HX93 humidity and temperature sensor (Omega Engineering, Stanford, CT, USA). Sweat rate will be defined as the product of the difference in water content between effluent and influent air and the flow rate. The flow rate through the capsule is 1.13 L min-1. The sweat rate value will be adjusted for skin surface area under the capsule (expressed in mg min-1 cm-2).	1 hour and 5 minutes
Primary	Change of thermal comfort	Thermal comfort was assessed via the thermal comfort scale (1 = comfortable; 5 = extremely uncomfortable)	Change from baseline thermal comfort at 10th, 20th, 30th, 40th, 50th and 65th minute.
Primary	Change of thermal sensation	Thermal sensation was assessed via the thermal sensation scale (-3 = cold; +3 = hot)	Change from baseline thermal sensation at 10th, 20th, 30th, 40th, 50th and 65th minute.