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Assessment of Vasomotion of People With Spinal Cord Injury

Primary Purpose

Spinal Cord Injuries, Paraplegia

Status

Completed

Phase

Not Applicable

Locations

Greece

Study Type

Interventional

Intervention

Cold environment participants with spinal cord injury

Thermoneutral environment participants with spinal cord injury

Warm environment participants with spinal cord injury

Cold environment healthy male participants

Thermoneutral environment healthy male participants

Warm environment healthy male participants

Cold environment healthy female participants

Thermoneutral environment healthy female participants

Warm environment healthy female participants

About this trial

This is an interventional prevention trial for Spinal Cord Injuries focused on measuring Spinal cord injury, vasomotion, core temperature, sudomotor, thermoregulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

FAME Lab, Department of Exercise Science, University of Thessaly

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Active Comparator

Arm Label

Cold environment participants with spinal cord injury

Thermoneutral environment participants with spinal cord injury

Warm environment participants with spinal cord injury

Cold environment healthy male participants

Thermoneutral environment healthy male participants

Warm environment healthy male participants

Cold environment healthy female participants

Thermoneutral environment healthy female participants

Warm enviroment healthy fmale participants

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Heart rate

Heart rate will be continuously monitored using a Polar Team system (Polar® Team 2, Polar Electro Oy, Kempele, Finland

Heart rate variability

Heart rate variability will be continuously monitored using a Polar Team system (Polar® Team 2, Polar Electro Oy, Kempele, Finland

Skin temperature

Skin temperature (chest, arm, thigh, and leg) will be continuously monitored using iButton sensors type DS1921 H, Maxim/Dallas Semiconductor Corp., USA.

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.

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.

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)

Change of blood pressure

Blood pressure will be monitored every 10 minutes with an automatic sphygmomanometer (Omron Healthcare M6 comfort, Japan)

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).

Change of thermal comfort

Thermal comfort was assessed via the thermal comfort scale (1 = comfortable; 5 = extremely uncomfortable)

Change of thermal sensation

Thermal sensation was assessed via the thermal sensation scale (-3 = cold; +3 = hot)

Secondary Outcome Measures

Full Information

NCT ID

NCT04215939

First Posted

December 30, 2019

Last Updated

November 3, 2020

Sponsor

Petros Dinas

Collaborators

European Commission

1. Study Identification

Unique Protocol Identification Number

NCT04215939

Brief Title

Assessment of Vasomotion of People With Spinal Cord Injury

Official Title

Assessment of Vasomotion of People With Spinal Cord Injury

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

February 1, 2019 (Actual)

Primary Completion Date

July 25, 2020 (Actual)

Study Completion Date

July 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Petros Dinas

Collaborators

European Commission

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

Detailed 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: Cold environment 15-17°C and 40-50% relative humidity Thermoneutral environment 22-24°C and 40-50% relative humidity 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Cord Injuries, Paraplegia

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cold environment participants with spinal cord injury

Arm Type

Experimental

Arm Description

Arm Title

Thermoneutral environment participants with spinal cord injury

Arm Type

Experimental

Arm Description

Arm Title

Warm environment participants with spinal cord injury

Arm Type

Experimental

Arm Description

Arm Title

Cold environment healthy male participants

Arm Type

Active Comparator

Arm Description

Arm Title

Thermoneutral environment healthy male participants

Arm Type

Active Comparator

Arm Description

Arm Title

Warm environment healthy male participants

Arm Type

Active Comparator

Arm Description

Arm Title

Cold environment healthy female participants

Arm Type

Active Comparator

Arm Description

Arm Title

Thermoneutral environment healthy female participants

Arm Type

Active Comparator

Arm Description

Arm Title

Warm enviroment healthy fmale participants

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Cold environment participants with spinal cord injury

Intervention Description

Intervention Type

Behavioral

Intervention Name(s)

Thermoneutral environment participants with spinal cord injury

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Warm environment participants with spinal cord injury

Intervention Description

Intervention Type

Behavioral

Intervention Name(s)

Cold environment healthy male participants

Intervention Description

Intervention Type

Behavioral

Intervention Name(s)

Thermoneutral environment healthy male participants

Intervention Description

Intervention Type

Behavioral

Intervention Name(s)

Warm environment healthy male participants

Intervention Description

Intervention Type

Behavioral

Intervention Name(s)

Cold environment healthy female participants

Intervention Description

Intervention Type

Behavioral

Intervention Name(s)

Thermoneutral environment healthy female participants

Intervention Description

Intervention Type

Behavioral

Intervention Name(s)

Warm environment healthy female participants

Intervention Description

Primary Outcome Measure Information:

Title

Heart rate

Description

Heart rate will be continuously monitored using a Polar Team system (Polar® Team 2, Polar Electro Oy, Kempele, Finland

Time Frame

1 hour and 5 minutes

Title

Heart rate variability

Description

Heart rate variability will be continuously monitored using a Polar Team system (Polar® Team 2, Polar Electro Oy, Kempele, Finland

Time Frame

1 hour and 5 minutes

Title

Skin temperature

Description

Skin temperature (chest, arm, thigh, and leg) will be continuously monitored using iButton sensors type DS1921 H, Maxim/Dallas Semiconductor Corp., USA.

Time Frame

1 hour and 5 minutes

Title

Finger temperature

Description

Time Frame

1 hour and 5 minutes

Title

Body core temperature

Description

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.

Time Frame

1 hour and 5 minutes

Title

Skin blood flow

Description

Time Frame

1 hour and 5 minutes

Title

Change of blood pressure

Description

Blood pressure will be monitored every 10 minutes with an automatic sphygmomanometer (Omron Healthcare M6 comfort, Japan)

Time Frame

Change from baseline blood pressure at 10th, 20th, 30th, 40th, 50th and 65th minute.

Title

Sweat rate

Description

Time Frame

1 hour and 5 minutes

Title

Change of thermal comfort

Description

Thermal comfort was assessed via the thermal comfort scale (1 = comfortable; 5 = extremely uncomfortable)

Time Frame

Change from baseline thermal comfort at 10th, 20th, 30th, 40th, 50th and 65th minute.

Title

Change of thermal sensation

Description

Thermal sensation was assessed via the thermal sensation scale (-3 = cold; +3 = hot)

Time Frame

Change from baseline thermal sensation at 10th, 20th, 30th, 40th, 50th and 65th minute.

10. Eligibility

Sex

All

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andreas Flouris, PhD

Organizational Affiliation

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

Official's Role

Study Chair

Facility Information:

Facility Name

FAME Lab, Department of Exercise Science, University of Thessaly

City

Tríkala

State/Province

Thessaly

ZIP/Postal Code

42100

Country

Greece

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Assessment of Vasomotion of People With Spinal Cord Injury

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