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临床试验/NCT06027502
NCT06027502尚未招募不适用

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

University of British Columbia2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2023年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
18
试验地点
2
主要终点
Core temperature

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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
  • 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

结局指标

主要结局

Core temperature

时间窗: 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

Blood pressure

时间窗: Continuously recorded - Baseline (Pre immersion - 20 minutes), Immersion (45 minutes) and Post-immersion/Recovery (60 to 90 minutes)

As measured indirectly by Finopres©

Cardiac output

时间窗: 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©

Oxygen consumption

时间窗: 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

Heart rate

时间窗: Continuously recorded - Baseline (Pre immersion - 20 minutes), Immersion (45 minutes) and Post-immersion/Recovery (60 to 90 minutes)

As measured indirectly by Finopres©

次要结局

  • 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))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

James Laskin

Adjunct Profesor

University of British Columbia

研究点 (2)

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