Spinal Cord InjuriesNCT04215939
Assessment of Vasomotion of People With Spinal Cord Injury
A study testing Cold environment participants with spinal cord injury, Thermoneutral environment participants with spinal cord injury and Warm environment participants with spinal cord injury in people with Spinal Cord Injuries and Paraplegia, run by Petros Dinas at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries, Paraplegia
- What is being tested?
- Cold environment participants with spinal cord injury, Thermoneutral environment participants with spinal cord injury and Warm environment participants with spinal cord injury
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteGreece
- Study dates
- 1 Feb 2019to 25 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Greece1 site
FAME Lab, Department of Exercise Science, University of Thessaly
Trikala, Thessaly, 42100
About this study
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).
Read the 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.
- Conditions
- Spinal Cord Injuries, Paraplegia
- Being tested
- 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
- Keywords
- Spinal cord injury, vasomotion, core temperature, sudomotor, thermoregulation
- Medical subject headings
- Spinal Cord Injuries, Paraplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold environment participants with spinal cord injuryBehavioural
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 injuryBehavioural
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 injuryBehavioural
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 participantsBehavioural
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 participantsBehavioural
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 participantsBehavioural
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 participantsBehavioural
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 participantsBehavioural
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 participantsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Warm environment participants with spinal cord injury; Behavioral: Warm environment healthy male participants; Behavioral: Warm environment healthy female participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
Heart rate will be continuously monitored using a Polar Team system (Polar® Team 2, Polar Electro Oy, Kempele, Finland
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 1 hour and 5 minutes
Change of thermal comfort
Thermal comfort was assessed via the thermal comfort scale (1 = comfortable; 5 = extremely uncomfortable)
Measured: 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)
Measured: Change from baseline thermal sensation at 10th, 20th, 30th, 40th, 50th and 65th minute.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start1 Feb 2019
- Primary completion25 Jul 2020
- Study completion25 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Petros Dinas
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission
- Responsible party
- Sponsor-investigator, Petros Dinas, University of Thessaly
- Investigators
- Andreas Flouris, PhD, Study chair, FAME Laboratory, Department of Exercise Science, University of Thessaly, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04215939
- Sponsor's protocol ID
- 9. Vasomotion & spinal
- Status last verified
- Nov 2020
- First submitted
- 30 Dec 2019
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Vasomotion of People With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT04215939
- Acronym / sponsor ID
- 9. Vasomotion & spinal
- Conditions
- Spinal Cord Injuries, Paraplegia
- Keywords
- Spinal cord injury, vasomotion, core temperature, sudomotor, thermoregulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Petros DinasUniversity, hospital or other
- Collaborators
- European Commission
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 25 Jul 2020 (actual)
- Study completion
- 25 Jul 2020 (actual)
- First posted
- 2 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Cold environment participants with spinal cord injury | Experimental | Behavioral: Cold environment participants with spinal cord injury, Behavioral: Cold environment healthy male participants, Behavioral: Cold environment healthy female participantsIn 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 | Experimental | Behavioral: Thermoneutral environment participants with spinal cord injury, Behavioral: Thermoneutral environment healthy male participants, Behavioral: Thermoneutral environment healthy female participantsIn 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. |
| Warm environment participants with spinal cord injury | Experimental | Behavioral: Warm environment participants with spinal cord injury, Behavioral: Warm environment healthy male participants, Behavioral: Warm environment healthy female participantsIn 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 | Active comparator | Behavioral: Cold environment participants with spinal cord injury, Behavioral: Cold environment healthy male participants, Behavioral: Cold environment healthy female participantsIn 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 | Active comparator | Behavioral: Thermoneutral environment participants with spinal cord injury, Behavioral: Thermoneutral environment healthy male participants, Behavioral: Thermoneutral environment healthy female participantsIn 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. |
| Warm environment healthy male participants | Active comparator | Behavioral: Warm environment participants with spinal cord injury, Behavioral: Warm environment healthy male participants, Behavioral: Warm environment healthy female participantsIn 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 | Active comparator | Behavioral: Cold environment participants with spinal cord injury, Behavioral: Cold environment healthy male participants, Behavioral: Cold environment healthy female participantsIn 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 | Active comparator | Behavioral: Thermoneutral environment participants with spinal cord injury, Behavioral: Thermoneutral environment healthy male participantsIn 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. |
| Warm enviroment healthy fmale participants | Active comparator | Behavioral: Warm environment participants with spinal cord injury, Behavioral: Warm environment healthy male participants, Behavioral: Warm environment healthy female participantsIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cold environment participants with spinal cord injuryIn 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. | Behavioural | Cold environment healthy female participants, Cold environment healthy male participants, Cold environment participants with spinal cord injury |
| Thermoneutral environment participants with spinal cord injuryIn 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. | Behavioural | Thermoneutral environment healthy female participants, Thermoneutral environment healthy male participants, Thermoneutral environment participants with spinal cord injury |
| Warm environment participants with spinal cord injuryIn 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. | Behavioural | Warm enviroment healthy fmale participants, Warm environment healthy male participants, Warm environment participants with spinal cord injury |
| Cold environment healthy male participantsIn 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. | Behavioural | Cold environment healthy female participants, Cold environment healthy male participants, Cold environment participants with spinal cord injury |
| Thermoneutral environment healthy male participantsIn 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. | Behavioural | Thermoneutral environment healthy female participants, Thermoneutral environment healthy male participants, Thermoneutral environment participants with spinal cord injury |
| Warm environment healthy male participantsIn 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. | Behavioural | Warm enviroment healthy fmale participants, Warm environment healthy male participants, Warm environment participants with spinal cord injury |
| Cold environment healthy female participantsIn 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. | Behavioural | Cold environment healthy female participants, Cold environment healthy male participants, Cold environment participants with spinal cord injury |
| Thermoneutral environment healthy female participantsIn 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. | Behavioural | Thermoneutral environment healthy male participants, Thermoneutral environment participants with spinal cord injury |
| Warm environment healthy female participantsIn 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. | Behavioural | Warm enviroment healthy fmale participants, Warm environment healthy male participants, Warm environment participants with spinal cord injury |
Primary outcome
Heart rate
Time frame: 1 hour and 5 minutes
Heart rate will be continuously monitored using a Polar Team system (Polar® Team 2, Polar Electro Oy, Kempele, Finland
Heart rate variability
Time frame: 1 hour and 5 minutes
Heart rate variability will be continuously monitored using a Polar Team system (Polar® Team 2, Polar Electro Oy, Kempele, Finland
Skin temperature
Time frame: 1 hour and 5 minutes
Skin temperature (chest, arm, thigh, and leg) will be continuously monitored using iButton sensors type DS1921 H, Maxim/Dallas Semiconductor Corp., USA.
Finger temperature
Time frame: 1 hour and 5 minutes
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
Time frame: 1 hour and 5 minutes
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
Time frame: 1 hour and 5 minutes
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
Time frame: Change from baseline blood pressure at 10th, 20th, 30th, 40th, 50th and 65th minute.
Blood pressure will be monitored every 10 minutes with an automatic sphygmomanometer (Omron Healthcare M6 comfort, Japan)
Sweat rate
Time frame: 1 hour and 5 minutes
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
Time frame: Change from baseline thermal comfort at 10th, 20th, 30th, 40th, 50th and 65th minute.
Thermal comfort was assessed via the thermal comfort scale (1 = comfortable; 5 = extremely uncomfortable)
Change of thermal sensation
Time frame: Change from baseline thermal sensation at 10th, 20th, 30th, 40th, 50th and 65th minute.
Thermal sensation was assessed via the thermal sensation scale (-3 = cold; +3 = hot)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Individual participant dataSharing planned: No
Related trials for Spinal Cord Injuries
Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
Recruiting
Transcutaneous Spinal Cord Stimulation Combined With 4-Aminopyridine and Intensive Rehabilitation in SCI
Spinal Cord Injuries
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury
Chronic Spinal Cord Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Flouris, PhD study chair
FAME Laboratory, Department of Exercise Science, University of Thessaly, Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold environment participants with spinal cord injury, Thermoneutral environment participants with spinal cord injury and Warm environment participants with spinal cord injury in people with Spinal Cord Injuries and Paraplegia, run by Petros Dinas at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate (time frame: 1 hour and 5 minutes). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.