Cardioprotective Benefit of Passive Heat Therapy in Higher-Level Spinal Cord Injury: Safety and Proof of Concept

NCT06027502 | Unknown

• 1 other identifier: H22-03599
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Spinal Cord Injuries; Cardiovascular Diseases; Health Behaviour; Physical Inactivity

Keywords

Spinal cord injury; Passive heating; Exercise response; Cardio protection

Outcome Measures

Primary Outcomes (5)

• Core temperature

  As measured by CorTemp smart pill and the Bair Hugger system

  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

  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©

  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©

  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©

  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

  Recorded every 5 minutes -Baseline (Pre immersion - 20 minutes), Immersion (45 minutes) and Post-immersion/Recovery (60 to 90 minutes)

• Brachial arterial blood flow

  Recorded every 5 minutes -Baseline (Pre immersion - 20 minutes), Immersion (45 minutes) and Post-immersion/Recovery (60 to 90 minutes)

Study Arms (1)

Passive Heating

EXPERIMENTAL

Passive heating will be achieved by approximately 45 min of immersion in a Hot Tub at 40 degrees celsius

Behavioral: Passive Heating

Interventions

Passive Heating BEHAVIORAL

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.

Passive Heating

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

ICORD Blusson SPinal Cord Centre

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Related Publications (4)

• 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.

  PMID: 27270841 BACKGROUND

• Larson 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.

  RESULT

• 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.

  PMID: 11326325 RESULT

• Brunt 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.

  PMID: 27418688 RESULT

MeSH Terms

Conditions

Spinal Cord Injuries; Cardiovascular Diseases; Sedentary Behavior

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Behavior

Study Officials

• James J Laskin, PT,PhD

  Department of Occupational Science & Occupational Therapy, UBC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James J Laskin, PT,PhD

CONTACT

6042003426; james.laskin@umontana.edu

Jaimie Borisoff, PhD

CONTACT

6047874243; Jaimie_Borisoff@bcit.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Profesor

Model Details: Two groups, those with a cervical level SCI and a control group of non-disabled healthy individuals

Study Record Dates

• First Submitted: July 30, 2023
• First Posted: September 7, 2023
• Study Start: September 15, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: September 7, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)