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Home-Based Heat Therapy in Spinal Cord Injury to Improve Cardiovascular Health

ConditionSCI - Spinal Cord Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorThe University of Texas Health Science Center at San Antonio

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participant demonstrates understanding of the study and has provided an appropriately signed and dated informed consent.

Participants will be male or female, 18-60 years of age, at the time of Visit 0.

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.

Stable SCI (AIS A or B) of longer than 1-year duration.

Disqualifiers

Uses daily administration of anti-inflammatory medications (stable doses of NSAIDs or statins are acceptable; steroids are exclusionary)

Uses daily administration of vasoactive medications (e.g., alpha antagonists or agonists or phosphodiesterase inhibitors).

Has a current pressure ulcer or skin breakdown.

Has an active, uncontrolled, autoimmune or inflammatory disorder

Trial design

Design model

Parallel

Treatments tested in this trial

  • HEAT - Passive Heat Therapy

    Other intervention

    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.

  • Sham (No Treatment)

    Other intervention

    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.

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: HEATExperimental treatment 1 intervention
Group B: SHAMSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Laser Doppler Flowmetry (LDF)

Measure of skin blood flow due to local skin heating

Time frame
From baseline to end of treatment at 8 weeks

Secondary outcomes

1

Endothelial Peripheral Arterial Tone (EndoPAT)

Measures the changes in finger pulsatile arterial volume

Time frame
Baseline to end of treatment at 8 weeks
2

Venous Occlusion Plethysmography (VOP)

Limb blood flow measurement

Time frame
From baseline to end of treatment at 8 weeks
3

Cardiac MRI

Measures stiffness of the aorta

Time frame
Baseline to end of treatment at 8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas Health Science Center at San Antonio

Lead sponsor

Congressionally Directed Medical Research Programs

Collaborator

Source ClinicalTrials.gov
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