Spinal Cord Injury, Chronic Inflammation, Glucose Metabolism, Endothelial Function
Conditions
Keywords
spinal cord injury
Brief summary
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.
Interventions
OTHERpassive heat stress
After arm 1, passive heat stress 3x/week x8 weeks.
OTHERControl
participant engage in activity as usual
Sponsors
VA Office of Research and Development
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
passive heat stress with water perfused heat suits and electrical heating blankets
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Interleukin-6 | change from 0 weeks to 8 weeks to 16 weeks | Plasma concentration, which was determined using enzyme-linked immunosorbent assays. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximal Cutaneous Vascular Conductance | change from 0 weeks to 8 weeks to 16 weeks | Cutaneous vascular conductance (CVC) in response to local heating measured via laser doppler flowmetry. Following heating of the skin for 10 min at a temperature of 34C, the skin was locally heated to 45C, which was maintained for at least 30 min (maximal CVC). The values in the data table reflect the percentage of maximum conductance of the skin at 34 degrees Celsius, when the skin is heated to 45 degrees Celsius at each time point (i.e., baseline, after control, and after intervention). |
| Glucose Tolerance | change from 0 to 8 to 16 weeks | glucose AUC from 3h oral glucose tolerance test |
| TNF-alpha | change from 0 to 8 to 16 weeks | plasma concentration |
| Interleukin-1ra | change from 0 to 8 to 16 weeks | plasma concentration |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMichelle B Trbovich, MD
South Texas Health Care System, San Antonio, TX
Participant flow
Pre-assignment details
Each enrolled participant completed a time-control phase of 8 weeks prior to the passive heating intervention.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 45 years STANDARD_DEVIATION 14 |
| BMI in kg/m2 | 28.0 kg/m2 STANDARD_DEVIATION 3 |
| Race/Ethnicity, Customized Black | 2 Participants |
| Race/Ethnicity, Customized Hispanic | 4 Participants |
| Race/Ethnicity, Customized White | 4 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 8 Participants |
| Years since injury | 9.2 years STANDARD_DEVIATION 10.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 1 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
None listed