Spinal Cord InjuriesNCT06027502
Cardioprotective Benefit of Passive Heat Therapy in Higher-Level Spinal Cord Injury: Safety and Proof of Concept
A study testing Passive Heating in people with Spinal Cord Injuries and Cardiovascular Diseases, run by University of British Columbia at 1 site in Canada.
Trial summary
As compared to the general population, those living with a spinal cord injury (SCI) are at a greater risk of cardiovascular (CV) diseases.The investigators know that regular exercise can help lessen the risk of CV diseases. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries, Cardiovascular Diseases, Health Behaviour
- What is being tested?
- Passive Heating
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- 15 Sep 2023to Dec 2023
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- sedentary to active individuals living with a spinal cord injury and have injury level between T7 and C4 (of any AIS level)*
- at least 2 years post-injury*
- be able to do a level transfer with minimal assistance*
- engaged in a regular and consistent bowel/bladder management program*
- be 19 years of age or older
- be able to communicate effectively in English
Show all 9Show fewer
- If present, self-reported well controlled/predictable orthostatic hypertension and/or autonomic dysreflexia*
- be fully vaccinated against COVID-19 (initial 2 doses and 1 booster)
- these criteria do not apply to the non-SCI controls
Who cannot join
- smoke/use tobacco products
- have any cardiac/respiratory illness or diabetes mellitus
- known diverticulitis
- hypertensive (Systolic Blood Pressure >140 mmHg and/or Diastolic Blood Pressure >190 mmHg)
- scheduled MRI investigation in the 7 days following the data collection session
- take prescription medications that affect blood vessels, other than contraceptives
Show all 19Show fewer
- have used an erectile dysfunction related medication (e.g., Viagra or Cialis) in the past 48 hours
- have unhealed fracture, or contracture, that would interfere with a simple chair to tub transfer and/or donning/doffing clothing
- have an unhealed pressure sore of any grade and/or open skin areas
- have unstable medical/psychiatric condition or substance abuse disorder that is likely to affect their ability to complete this study
- have underlying health conditions or injuries that would impact their ability to tolerate a mild exercise response or hot water immersion
- have uncontrolled orthostatic hypotension i.e., blood pressure does not return to normal within 2-3 minutes after standing or transferring*
- have underlying health conditions that put them at greater risk for COVID-19 (e.g., respiratory illness, compromised immunity, or chronic health condition)
- have any COVID-19 related symptoms (e.g., new or worsening cough, shortness of breath, sore throat, runny nose or nasal congestion, hoarse voice, difficulty swallowing, new smell or taste disorders, nausea, vomiting, diarrhea, abdominal pain, unexplained fatigue, chills or headache)
- have a fever
- have travelled outside Canada or had close contact with anyone who has travelled outside Canada in the past 14 days
- have close contact with anyone with respiratory illness or a confirmed or probable case of COVID-19
- are currently self-isolating
- these criteria do not apply to the non-SCI controls
Trial locations and contacts
1 site in 1 country.
Canada1 site
ICORD Blusson SPinal Cord Centre
Vancouver, British Columbia, V5Z 1M9
About this study
As compared to the general population, those living with a spinal cord injury (SCI) are at a greater risk of cardiovascular (CV) diseases.The investigators know that regular exercise can help lessen the risk of CV diseases. However, those with higher level SCI have a limited ability to exercise due to their loss of function. Heat therapy has been shown to promote significant health benefits in populations with health challenges and has demonstrated a mild exercise like response. The investigators aim to extend these findings and develop a practical passive heat therapy program appropriate for safe home use.
Read the detailed description
The risk of cardiovascular diseases for people with a spinal cord injury (SCI) is approximately 3x greater than the general population, and Cardiovascular (CV) diseases account for ~40% of deaths in SCI. Traditional CV risk factors are unable to fully explain these outcomes. This group also has other secondary complications that are concerning, including susceptibility to infections and metabolic health issues. Some of the increased risk in SCI is due to a relatively sedentary lifestyle and insufficient exercise capability. This is particularly insidious in those living with tetraplegia with poor cardiovascular responses to exercise or even the inability to exercise due to upper limb paralysis.
Heat therapy in the form of hot baths and saunas has been utilized for centuries, with common reports of improved quality of life and overall improved well-being. A 20-year prospective study on 2,315 middle-aged men (at enrolment) in Finland reported that regular sauna bathing was associated with reduced risk of sudden cardiac death, coronary heart disease, CV disease, and all-cause mortality. Further, more frequent sauna bathing sessions were related to a considerably decreased risk of fatal cardiac and CV events, as well as all-cause mortality independently from conventional risk factors, activity levels, and diet. The mechanisms which underlie these improvements remain largely unknown. It has been proposed that CV benefits of exercise training are partly mediated by repeated increases in core temperature. Exercise and heat stress elicit many common physiological responses, including increases in core temperature, heart rate and contractility, redistribution of blood flow, and changes in conduit vessel endothelial shear stress, all of which are believed to improve CV health. Additionally, heat exposure and exercise induce the expression of heat shock proteins, which stabilize a variety of other proteins that reduce vascular inflammation and oxidative stress, improve NO bioavailability, promote angiogenesis, and improve glucose signaling.
SCI results in a host of physiological changes that greatly increase CV risk and vascular dysfunction following injury. Increased arterial stiffness and vascular resistance are common features in SCI, likely secondary to the loss of sympathetic innervation below the lesion, increased circulating vasoconstrictors, and subsequent oxidative stress and vascular inflammation. Heat exposure is a stress to the CV system, like exercise, which may result in numerous chronic adaptations that improve vascular and metabolic function, resulting in a profoundly reduced risk of CV disease.
Passive heat therapy may provide a novel and practical approach to help these individuals. There have been observed profound improvements in vascular and metabolic function as well as indications of benefits to the immune system and reductions in inflammation in healthy but sedentary able-bodied people after long-term passive heat exposure. Similar benefits were observed in obese women with polycystic ovary syndrome. Recent studies in SCI with lower limb and full-body (only in low level SCI) immersion have demonstrated the potential of hot water immersion to be safe, with the potential to stimulate a cardio-protective response. The proposed pilot study is the first step in developing a unique approach for combating CV dysfunction in the SCI population.
Specifically, the goal of this pilot study is to build on the current literature and demonstrate the safety, tolerance, and effectiveness (providing a mild/moderate exercise response) of a ~ 45-minute full-body hot water immersion in those with higher level SCI (T7-C4). Ultimately, the investigators will develop a protocol for translating these and future findings to the home environment and use of a typical bathtub, thereby demonstrating that passive heat therapy is a viable approach to improve health in the SCI population.
Water immersion is the preferred method of heating since it is capable of increasing core temperature and heart rate at a rate similar to moderate-intensity exercise. It is difficult to achieve increases in core temperature solely via air convection, including in paraplegic SCI, as participants rapidly acclimate to the heat with increased sweating, limiting the rise in core temperature and heart rate. In addition, hot tubs, whirlpools, and baths are available in the community, and most should provide wheelchair access. In addition, a water bath in the home is an acceptable alternative to a hot tub to sufficiently raise core body temperature. Furthermore, water is an excellent conductor of heat, and will provide uniform heating across the participants' body. This helps eliminate "hot spots" that could result in a burn, particularly in insensate areas of skin.
For this study, up to 16 individuals will be recruited from International Collaboration on Repair Discoveries (ICORD) Physical Activity Research Centre (PARC) Community as well as from the larger SCI community who live with a T7-C4 injury. In addition, the investigators will be recruiting up to 6 control participants who are otherwise healthy individuals who do not live with an SCI. During the single, approximately 45-minute exposure to this passive heating modality the investigators will be measuring heart rate, blood pressure (mean arterial pressure), cardiac output, respiration rate and core temperature. This descriptive study will have each participant attend the lab for a single session.
After a 20 min of baseline data collection period the participant will be transferred to the hot tub using a standard Hoyer lift and sling. While in the hot tub they will remain in a semi-reclined position. Initially the participant will be submersed up to the clavicular level with one arm out of water until the core temperature reaches 38.5 C (about 20 - 25 minutes), once this temperature has been reached, they will be positioned so that the water level lays between the waist and mid-sternum. The water level on the participant's body will be adjusted such that a core temperature of 38.5 C for 20 minutes (typical moderate exercise duration) is maintained. If the participants core temperature exceeds 39.5 C the session will be terminated and the participant removed from the hot tub. While in the hot tub the participant may drink water ad lib with the volume recorded.
While submersed in the hot tub:
- Core temperature, blood pressure, blood flow, and heart rate will be monitored continuously
- Oxygen consumption will be assessed every 5 minutes
- Cardiac output will be assessed every 10 minutes
Once the ~45 min of immersion has been completed the participant will be removed from the hot tub using the Hoyer lift and placed back on the plinth in a semi-reclined position for 20 minutes of recovery/rest. While in this recovery position core temperature, blood pressure, blood flow, and heart rate will be monitored continuously.
After this initial recovery period the investigators will assist the participant as necessary to help the participant get dressed, weighed, testing equipment removed and will continue resting comfortably in the participant's everyday wheelchair for 60-90 min.
The outcome variables to be examined include the following:
- Heart rate
- Blood pressure (systolic, diastolic, mean arterial pressure, beat to beat)
- Core temperature (via CorTemp© "smart pill and Bear Hugger)
- Cardiac output
- Oxygen consumption
- Brachial and cerebral artery blood flow
- End tidal gas - respiration rate
- Weight loss
Each of the outcome variables will be examined in both an individual and pooled manner (average and standard deviation). In addition, any potential group trends (e.g., injury level [thoracic versus cervical] and severity [ American Spinal Injury Association Impairment Scale (AIS) score]) in terms of the response to the passive heating stimulus will be examined.
- Being tested
- Passive Heating
- Keywords
- Spinal cord injury, Passive heating, Exercise response, Cardio protection
- Medical subject headings
- Spinal Cord Injuries, Cardiovascular Diseases, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive HeatingBehavioural
20 minutes of baseline data collection, up to 45 minutes of immersion in the hot tub to achieve a core temperature of 38.5 degrees celsius, followed by up to 90 minutes of recovery.
| Study group | Role | What they receive |
|---|---|---|
| Passive Heating | Experimental | Passive heating will be achieved by approximately 45 min of immersion in a Hot Tub at 40 degrees celsius Receives: Behavioral: Passive Heating |
What is being measured
The primary outcome is the main question the study is designed to answer.
Core temperature
As measured by CorTemp smart pill and the Bair Hugger system
Measured: Continuously recorded - Baseline (Pre immersion - 20 minutes), Immersion (45 minutes) and Post-immersion/Recovery (60 to 90 minutes)
Oxygen consumption
As measured by open circuit spirometer
Measured: Recorded every 5 minutes -Baseline (Pre immersion - 20 minutes), Immersion (45 minutes) and Post-immersion/Recovery (60 to 90 minutes)
Cardiac output
As measured indirectly by Finopres©
Measured: Recorded every 5 minutes -Baseline (Pre immersion - 20 minutes), Immersion (45 minutes) and Post-immersion/Recovery (60 to 90 minutes)
Blood pressure
As measured indirectly by Finopres©
Measured: Continuously recorded - Baseline (Pre immersion - 20 minutes), Immersion (45 minutes) and Post-immersion/Recovery (60 to 90 minutes)
Heart rate
As measured indirectly by Finopres©
Measured: Continuously recorded - Baseline (Pre immersion - 20 minutes), Immersion (45 minutes) and Post-immersion/Recovery (60 to 90 minutes)
Secondary outcomes (2)
Cerebral artery blood flow
As measured by arterial doppler ultrasound
Measured: Recorded every 5 minutes -Baseline (Pre immersion - 20 minutes), Immersion (45 minutes) and Post-immersion/Recovery (60 to 90 minutes)
Brachial arterial blood flow
As measured by arterial doppler ultrasound
Measured: Recorded every 5 minutes -Baseline (Pre immersion - 20 minutes), Immersion (45 minutes) and Post-immersion/Recovery (60 to 90 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start15 Sep 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Two groups, those with a cervical level SCI and a control group of non-disabled healthy individuals
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Laskin, University of British Columbia
- Investigators
- James J Laskin, PT,PhD, Principal investigator, Department of Occupational Science & Occupational Therapy, UBC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06027502
- Sponsor's protocol ID
- H22-03599
- Status last verified
- Aug 2023
- First submitted
- 30 Jul 2023
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brunt VE, Howard MJ, Francisco MA, Ely BR, Minson CT. Passive heat therapy improves endothelial function, arterial stiffness and blood pressure in sedentary humans. J Physiol. 2016 Sep 15;594(18):5329-42. doi: 10.1113/JP272453. Epub 2016 Jun 30.
PubMed 27270841Larson EA, Ely BR, Francisco, MA, Brunt VE, Minson CT. Thermoregulatory Response to Acute Passive Heat Exposure in Individuals with Low-level Spinal Cord Injury. FASEB J. 2019;33(1):838.19.
Gass EM, Gass GC. Thermoregulatory responses to repeated warm water immersion in subjects who are paraplegic. Spinal Cord. 2001 Mar;39(3):149-55. doi: 10.1038/sj.sc.3101117.
PubMed 11326325Brunt VE, Eymann TM, Francisco MA, Howard MJ, Minson CT. Passive heat therapy improves cutaneous microvascular function in sedentary humans via improved nitric oxide-dependent dilation. J Appl Physiol (1985). 2016 Sep 1;121(3):716-23. doi: 10.1152/japplphysiol.00424.2016. Epub 2016 Jul 14.
PubMed 27418688
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardioprotective Benefit of Passive Heat Therapy in Higher-Level Spinal Cord Injury: Safety and Proof of Concept
- ClinicalTrials.gov ID
- NCT06027502
- Acronym / sponsor ID
- H22-03599
- Keywords
- Spinal cord injury, Passive heating, Exercise response, Cardio protection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 15 Sep 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 7 Sep 2023 (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.
As compared to the general population, those living with a spinal cord injury (SCI) are at a greater risk of cardiovascular (CV) diseases.The investigators know that regular exercise can help lessen the risk of CV diseases. However, those with higher level SCI have a limited ability to exercise due to their loss of function. Heat therapy has been shown to promote significant health benefits in populations with health challenges and has demonstrated a mild exercise like response. The investigators aim to extend these findings and develop a practical passive heat therapy program appropriate for safe home use.
Detailed description
The risk of cardiovascular diseases for people with a spinal cord injury (SCI) is approximately 3x greater than the general population, and Cardiovascular (CV) diseases account for ~40% of deaths in SCI. Traditional CV risk factors are unable to fully explain these outcomes. This group also has other secondary complications that are concerning, including susceptibility to infections and metabolic health issues. Some of the increased risk in SCI is due to a relatively sedentary lifestyle and insufficient exercise capability. This is particularly insidious in those living with tetraplegia with poor cardiovascular responses to exercise or even the inability to exercise due to upper limb paralysis.
Heat therapy in the form of hot baths and saunas has been utilized for centuries, with common reports of improved quality of life and overall improved well-being. A 20-year prospective study on 2,315 middle-aged men (at enrolment) in Finland reported that regular sauna bathing was associated with reduced risk of sudden cardiac death, coronary heart disease, CV disease, and all-cause mortality. Further, more frequent sauna bathing sessions were related to a considerably decreased risk of fatal cardiac and CV events, as well as all-cause mortality independently from conventional risk factors, activity levels, and diet. The mechanisms which underlie these improvements remain largely unknown. It has been proposed that CV benefits of exercise training are partly mediated by repeated increases in core temperature. Exercise and heat stress elicit many common physiological responses, including increases in core temperature, heart rate and contractility, redistribution of blood flow, and changes in conduit vessel endothelial shear stress, all of which are believed to improve CV health. Additionally, heat exposure and exercise induce the expression of heat shock proteins, which stabilize a variety of other proteins that reduce vascular inflammation and oxidative stress, improve NO bioavailability, promote angiogenesis, and improve glucose signaling.
SCI results in a host of physiological changes that greatly increase CV risk and vascular dysfunction following injury. Increased arterial stiffness and vascular resistance are common features in SCI, likely secondary to the loss of sympathetic innervation below the lesion, increased circulating vasoconstrictors, and subsequent oxidative stress and vascular inflammation. Heat exposure is a stress to the CV system, like exercise, which may result in numerous chronic adaptations that improve vascular and metabolic function, resulting in a profoundly reduced risk of CV disease.
Passive heat therapy may provide a novel and practical approach to help these individuals. There have been observed profound improvements in vascular and metabolic function as well as indications of benefits to the immune system and reductions in inflammation in healthy but sedentary able-bodied people after long-term passive heat exposure. Similar benefits were observed in obese women with polycystic ovary syndrome. Recent studies in SCI with lower limb and full-body (only in low level SCI) immersion have demonstrated the potential of hot water immersion to be safe, with the potential to stimulate a cardio-protective response. The proposed pilot study is the first step in developing a unique approach for combating CV dysfunction in the SCI population.
Specifically, the goal of this pilot study is to build on the current literature and demonstrate the safety, tolerance, and effectiveness (providing a mild/moderate exercise response) of a ~ 45-minute full-body hot water immersion in those with higher level SCI (T7-C4). Ultimately, the investigators will develop a protocol for translating these and future findings to the home environment and use of a typical bathtub, thereby demonstrating that passive heat therapy is a viable approach to improve health in the SCI population.
Water immersion is the preferred method of heating since it is capable of increasing core temperature and heart rate at a rate similar to moderate-intensity exercise. It is difficult to achieve increases in core temperature solely via air convection, including in paraplegic SCI, as participants rapidly acclimate to the heat with increased sweating, limiting the rise in core temperature and heart rate. In addition, hot tubs, whirlpools, and baths are available in the community, and most should provide wheelchair access. In addition, a water bath in the home is an acceptable alternative to a hot tub to sufficiently raise core body temperature. Furthermore, water is an excellent conductor of heat, and will provide uniform heating across the participants' body. This helps eliminate "hot spots" that could result in a burn, particularly in insensate areas of skin.
For this study, up to 16 individuals will be recruited from International Collaboration on Repair Discoveries (ICORD) Physical Activity Research Centre (PARC) Community as well as from the larger SCI community who live with a T7-C4 injury. In addition, the investigators will be recruiting up to 6 control participants who are otherwise healthy individuals who do not live with an SCI. During the single, approximately 45-minute exposure to this passive heating modality the investigators will be measuring heart rate, blood pressure (mean arterial pressure), cardiac output, respiration rate and core temperature. This descriptive study will have each participant attend the lab for a single session.
After a 20 min of baseline data collection period the participant will be transferred to the hot tub using a standard Hoyer lift and sling. While in the hot tub they will remain in a semi-reclined position. Initially the participant will be submersed up to the clavicular level with one arm out of water until the core temperature reaches 38.5 C (about 20 - 25 minutes), once this temperature has been reached, they will be positioned so that the water level lays between the waist and mid-sternum. The water level on the participant's body will be adjusted such that a core temperature of 38.5 C for 20 minutes (typical moderate exercise duration) is maintained. If the participants core temperature exceeds 39.5 C the session will be terminated and the participant removed from the hot tub. While in the hot tub the participant may drink water ad lib with the volume recorded.
While submersed in the hot tub:
- Core temperature, blood pressure, blood flow, and heart rate will be monitored continuously
- Oxygen consumption will be assessed every 5 minutes
- Cardiac output will be assessed every 10 minutes
Once the ~45 min of immersion has been completed the participant will be removed from the hot tub using the Hoyer lift and placed back on the plinth in a semi-reclined position for 20 minutes of recovery/rest. While in this recovery position core temperature, blood pressure, blood flow, and heart rate will be monitored continuously.
After this initial recovery period the investigators will assist the participant as necessary to help the participant get dressed, weighed, testing equipment removed and will continue resting comfortably in the participant's everyday wheelchair for 60-90 min.
The outcome variables to be examined include the following:
- Heart rate
- Blood pressure (systolic, diastolic, mean arterial pressure, beat to beat)
- Core temperature (via CorTemp© "smart pill and Bear Hugger)
- Cardiac output
- Oxygen consumption
- Brachial and cerebral artery blood flow
- End tidal gas - respiration rate
- Weight loss
Each of the outcome variables will be examined in both an individual and pooled manner (average and standard deviation). In addition, any potential group trends (e.g., injury level [thoracic versus cervical] and severity [ American Spinal Injury Association Impairment Scale (AIS) score]) in terms of the response to the passive heating stimulus will be examined.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Two groups, those with a cervical level SCI and a control group of non-disabled healthy individuals
| Arm | Type | Receives |
|---|---|---|
| Passive Heating | Experimental | Behavioral: Passive HeatingPassive heating will be achieved by approximately 45 min of immersion in a Hot Tub at 40 degrees celsius |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- sedentary to active individuals living with a spinal cord injury and have injury level between T7 and C4 (of any AIS level)*
- at least 2 years post-injury*
- be able to do a level transfer with minimal assistance*
- engaged in a regular and consistent bowel/bladder management program*
- be 19 years of age or older
Key exclusion criteria (19 listed)
- smoke/use tobacco products
- have any cardiac/respiratory illness or diabetes mellitus
- known diverticulitis
- hypertensive (Systolic Blood Pressure >140 mmHg and/or Diastolic Blood Pressure >190 mmHg)
- scheduled MRI investigation in the 7 days following the data collection session
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 |
|---|---|---|
| Passive Heating20 minutes of baseline data collection, up to 45 minutes of immersion in the hot tub to achieve a core temperature of 38.5 degrees celsius, followed by up to 90 minutes of recovery. | Behavioural | Passive Heating |
Primary outcome
Core temperature
Time frame: Continuously recorded - Baseline (Pre immersion - 20 minutes), Immersion (45 minutes) and Post-immersion/Recovery (60 to 90 minutes)
As measured by CorTemp smart pill and the Bair Hugger system
Oxygen consumption
Time frame: Recorded every 5 minutes -Baseline (Pre immersion - 20 minutes), Immersion (45 minutes) and Post-immersion/Recovery (60 to 90 minutes)
As measured by open circuit spirometer
Cardiac output
Time frame: Recorded every 5 minutes -Baseline (Pre immersion - 20 minutes), Immersion (45 minutes) and Post-immersion/Recovery (60 to 90 minutes)
As measured indirectly by Finopres©
Blood pressure
Time frame: Continuously recorded - Baseline (Pre immersion - 20 minutes), Immersion (45 minutes) and Post-immersion/Recovery (60 to 90 minutes)
As measured indirectly by Finopres©
Heart rate
Time frame: Continuously recorded - Baseline (Pre immersion - 20 minutes), Immersion (45 minutes) and Post-immersion/Recovery (60 to 90 minutes)
As measured indirectly by Finopres©
2 secondary outcomes
Cerebral artery blood flow
Time frame: Recorded every 5 minutes -Baseline (Pre immersion - 20 minutes), Immersion (45 minutes) and Post-immersion/Recovery (60 to 90 minutes)
Brachial arterial blood flow
Time frame: Recorded every 5 minutes -Baseline (Pre immersion - 20 minutes), Immersion (45 minutes) and Post-immersion/Recovery (60 to 90 minutes)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Background: PubMed 27270841Brunt VE, Howard MJ, Francisco MA, Ely BR, Minson CT. Passive heat therapy improves endothelial function, arterial stiffness and blood pressure in sedentary humans. J Physiol. 2016 Sep 15;594(18):5329-42. doi: 10.1113/JP272453. Epub 2016 Jun 30.
- Results publicationLarson EA, Ely BR, Francisco, MA, Brunt VE, Minson CT. Thermoregulatory Response to Acute Passive Heat Exposure in Individuals with Low-level Spinal Cord Injury. FASEB J. 2019;33(1):838.19.
- Results publication: PubMed 11326325Gass EM, Gass GC. Thermoregulatory responses to repeated warm water immersion in subjects who are paraplegic. Spinal Cord. 2001 Mar;39(3):149-55. doi: 10.1038/sj.sc.3101117.
- Results publication: PubMed 27418688Brunt VE, Eymann TM, Francisco MA, Howard MJ, Minson CT. Passive heat therapy improves cutaneous microvascular function in sedentary humans via improved nitric oxide-dependent dilation. J Appl Physiol (1985). 2016 Sep 1;121(3):716-23. doi: 10.1152/japplphysiol.00424.2016. Epub 2016 Jul 14.
- Individual participant dataSharing planned: No
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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.
James J Laskin, PT,PhD principal investigator
Department of Occupational Science & Occupational Therapy, UBC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Passive Heating in people with Spinal Cord Injuries and Cardiovascular Diseases, run by University of British Columbia at 1 site in Canada.
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 9 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 7 Sep 2023. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James J Laskin, PT,PhD (6042003426, james.laskin@umontana.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Core temperature (time frame: Continuously recorded - Baseline (Pre immersion - 20 minutes), Immersion (45 minutes) and Post-immersion/Recovery (60 to 90 minutes)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06027502, which also lists 4 linked publications.
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 7 Sep 2023.