Impact of Passive Heat on Metabolic, Inflammatory and Vascular Health in Persons With Spinal Cord Injury (SCIPHS)

VA Office of Research and Development

Status: Completed

Conditions: Endothelial Function; Chronic Inflammation; Glucose Metabolism; Spinal Cord Injury

Treatments: Other: control; Other: passive heat stress

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT04971408

B3724-P

Details and patient eligibility

About

SCI results in higher incidence of heart disease and diabetes and heart disease is the most common cause of death. Chronic inflammation, deleterious changes in vascular structure and impaired glucose metabolism are risk factors that contribute to both heart disease and diabetes. While exercise can help reduce these risk factors, paralysis and impaired accessibility often precludes exercise in persons with SCI. New research in able-bodied persons demonstrates passive heating decreases inflammation and improves vascular function. Similar studies in persons with SCI suggest they may also have the same health benefits however these studies only investigated the impact of short term (one episode) passive heating (as opposed to repeated bouts). Repeated bouts of heat exposure will likely be required to impact chronic inflammation, but this has never been tested in persons with SCI. This study will test the impact of repeated bouts (3x/week) of passive heat stress over a longer term (8 weeks) on inflammation, metabolism and vascular function.

Enrollment: 10 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Stable SCI over 1 year of duration

Exclusion criteria

• Persons who smoke cigarettes
• Daily administration of anti-inflammatory medications
• Daily administration of vasoactive medications
• Pressure ulcer stage 3 or 4
• History of heat related illness

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

control

Other group

Description:

passive heat stress x1 visit then no intervention for 8 weeks. participants continue regular exercise habits as usual.

Treatment:

Other: control

Passive heat stress

Experimental group

Description:

After arm 1, passive heat stress 3x/week x8 weeks.

Treatment:

Other: passive heat stress