Home-Based Passive Heat Therapy-Towards a Scalable Intervention to Improve Cardiovascular Health in Persons With Spinal Cord Injury
The University of Texas Health Science Center at San Antonio
Summary
The study is designed to investigate the effects of passive heat therapy on blood vessel health in 40 people (48 enrolled with attrition rate of 20%). Following an extensive set of vascular function tests, participants will engage in either a passive heat therapy intervention for 60 minutes, 4 times a week for 8 weeks, or a placebo intervention at a lower temperature. Seven of the 8 weeks of intervention will occur in the home setting. Vascular function tests will be repeated after the 8 weeks to determine if chronic passive heat stress improved vascular health.
Description
The experimental arm (HEAT) participants undergo an 8-week intervention with 4 weekly passive heat therapy sessions. The aim of each session is to raise the participants' core temperature by at least 1°C by resting under heating blankets set at approximately 42°C. The control arm (SHAM) participants undergo the same procedure as above except the temperature setting of the blankets is lower at approximately 34°C. Screening, baseline assessments and the first 4 sessions will be conducted in the investigator's SCI lab to familiarize the participant with how to apply the heating blankets and ensu…
Eligibility
- Age range
- 18–60 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Participant demonstrates understanding of the study and has provided an appropriately signed and dated informed consent. 2. Participants will be male or female, 18-60 years of age, at the time of Visit 0. 3. Female participants must be non-lactating. Female patients are eligible only if they have a negative pregnancy test throughout the study period (or are postmenopausal). Postmenopausal women taking hormone replacement will be included if they have been on a stable dose for =6 months. 4. Stable SCI (AIS A or B) of longer than 1-year duration. 5. Use of medications for…
Interventions
- OtherHEAT - Passive Heat Therapy
Participant rests under a heated blanket until the core body temperature has increased at minimum 1 degree Celsius. This usually takes approximately 1 hour. The intervention is performed 4 times a week for a total of 8 weeks.
- OtherSham (No Treatment)
The SHAM intervention participant will rest under a heated blanket that is not set to the degree that the HEAT arm receives. There is no increase of core body temperature.
Location
- Audie L Murphy Veterans Memorial Hospital, South Texas Veterans Health Care SystemSan Antonio, Texas