Assessment of Vasomotion of People With Spinal Cord Injury

NCT04215939 | Completed

• 1 other identifier: 9. Vasomotion & spinal
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Spinal Cord Injuries; Paraplegia

Keywords

Spinal cord injury; vasomotion; core temperature; sudomotor; thermoregulation

Outcome Measures

Primary Outcomes (10)

• 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

• 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

• 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

• 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

• 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

• 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

• 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.

• 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

• 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.

• 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.

Study Arms (9)

Cold environment participants with spinal cord injury

EXPERIMENTAL

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.

Behavioral: Cold environment participants with spinal cord injury; Behavioral: Cold environment healthy male participants; Behavioral: Cold environment healthy female participants

Thermoneutral environment participants with spinal cord injury

EXPERIMENTAL

In a thermoneutral enviroment (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.

Behavioral: Thermoneutral environment participants with spinal cord injury; Behavioral: Thermoneutral environment healthy male participants; Behavioral: Thermoneutral environment healthy female participants

Warm environment participants with spinal cord injury

EXPERIMENTAL

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.

Behavioral: Warm environment participants with spinal cord injury; Behavioral: Warm environment healthy male participants; Behavioral: Warm environment healthy female participants

Cold environment healthy male participants

ACTIVE COMPARATOR

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.

Behavioral: Cold environment participants with spinal cord injury; Behavioral: Cold environment healthy male participants; Behavioral: Cold environment healthy female participants

Thermoneutral environment healthy male participants

ACTIVE COMPARATOR

In a thermoneutral enviroment (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.

Behavioral: Thermoneutral environment participants with spinal cord injury; Behavioral: Thermoneutral environment healthy male participants; Behavioral: Thermoneutral environment healthy female participants

Warm environment healthy male participants

ACTIVE COMPARATOR

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.

Behavioral: Warm environment participants with spinal cord injury; Behavioral: Warm environment healthy male participants; Behavioral: Warm environment healthy female participants

Cold environment healthy female participants

ACTIVE COMPARATOR

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.

Behavioral: Cold environment participants with spinal cord injury; Behavioral: Cold environment healthy male participants; Behavioral: Cold environment healthy female participants

Thermoneutral environment healthy female participants

ACTIVE COMPARATOR

In a thermoneutral enviroment (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.

Behavioral: Thermoneutral environment participants with spinal cord injury; Behavioral: Thermoneutral environment healthy male participants

Warm enviroment healthy fmale participants

ACTIVE COMPARATOR

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.

Behavioral: Warm environment participants with spinal cord injury; Behavioral: Warm environment healthy male participants; Behavioral: Warm environment healthy female participants

Interventions

Cold environment participants with spinal cord injury BEHAVIORAL

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.

Cold environment healthy female participants; Cold environment healthy male participants; Cold environment participants with spinal cord injury

Thermoneutral environment participants with spinal cord injury BEHAVIORAL

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.

Thermoneutral environment healthy female participants; Thermoneutral environment healthy male participants; Thermoneutral environment participants with spinal cord injury

Warm environment participants with spinal cord injury BEHAVIORAL

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.

Warm enviroment healthy fmale participants; Warm environment healthy male participants; Warm environment participants with spinal cord injury

Cold environment healthy male participants BEHAVIORAL

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.

Cold environment healthy female participants; Cold environment healthy male participants; Cold environment participants with spinal cord injury

Thermoneutral environment healthy male participants BEHAVIORAL

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.

Thermoneutral environment healthy female participants; Thermoneutral environment healthy male participants; Thermoneutral environment participants with spinal cord injury

Warm environment healthy male participants BEHAVIORAL

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.

Warm enviroment healthy fmale participants; Warm environment healthy male participants; Warm environment participants with spinal cord injury

Cold environment healthy female participants BEHAVIORAL

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.

Cold environment healthy female participants; Cold environment healthy male participants; Cold environment participants with spinal cord injury

Thermoneutral environment healthy female participants BEHAVIORAL

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.

Thermoneutral environment healthy male participants; Thermoneutral environment participants with spinal cord injury

Warm environment healthy female participants BEHAVIORAL

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.

Warm enviroment healthy fmale participants; Warm environment healthy male participants; Warm environment participants with spinal cord injury

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Petros Dinas: lead
• European Commission: collaborator

Study Sites (1)

FAME Lab, Department of Exercise Science, University of Thessaly

Trikala, Thessaly, 42100, Greece

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Paraplegia

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andreas Flouris, PhD

  FAME Laboratory, Department of Exercise Science, University of Thessaly, Greece

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Researcher in human physiology

Study Record Dates

• First Submitted: December 30, 2019
• First Posted: January 2, 2020
• Study Start: February 1, 2019
• Primary Completion: July 25, 2020
• Study Completion: July 25, 2020
• Last Updated: November 4, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)