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Spinal Cord Injury (SCI) for Cardiovascular Disease (DRPP Trial)

N/A
Waitlist Available
Led By Mark S Nash, PhD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up -2 months (wash) to baseline (0 months); to 6 months and 12 months and baseline (0 months) to 6 months and 12 months
Awards & highlights

DRPP Trial Summary

This trial will help researchers understand the best way to help people with chronic SCI, as well as their caregivers.

Eligible Conditions
  • Cardiovascular Disease
  • Spinal Cord Injury
  • Obesity

DRPP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~-2 months (wash) to baseline (0 months); to 6 months and 12 months and baseline (0 months) to 6 months and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and -2 months (wash) to baseline (0 months); to 6 months and 12 months and baseline (0 months) to 6 months and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in Fitness indicators as measured by Body Mass index (BMI)-
Secondary outcome measures
Change from baseline in Cardioendocrine and Global Cardiovascular risk by surrogate blood measures of the Homeostasis Model Assessment -Insulin Resistance (HOMA 2-IR) in SCI individuals and caregivers (unitless)
Change from baseline in Cardioendocrine and Global Cardiovascular risk by surrogate blood measures of the Total Cholesterol(TC): High Density high-density lipoprotein(HDL) ratio in SCI individuals and caregivers
Change from baseline in Fitness indicators as measured by Endurance-maximal oxygen consumption (Vo2 peak test)individuals and their caregivers
+3 more
Other outcome measures
Change from baseline in Basic Pain and Classification after SCI -The International SCI Basic Pain Data Set (ISCIBPDS)
Change from baseline in Caregiver Function- Patient-Reported Outcomes Measurement Information System (PROMIS)
Change from baseline in Multi-dimensional Pain-The West Haven-Yale Multi-dimensional Pain Inventory (MPI)
+2 more

DRPP Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Spinal Cord Injury (SCI)Experimental Treatment1 Intervention
Experimental: Lifestyle Intervention This arm will examine whether a twelve month treatment program (one year) for Spinal Cord injury individuals enrolled with their caregivers, can lower body weight, reduce body fat, reduce risk factors for developing heart disease and diabetes, and improve the quality of life using a 6 months of structured lifestyle intervention incorporating education, exercise, diet, and behavioral support.
Group II: Caregiver Intervention(CCC)Active Control1 Intervention
Lifestyle Intervention This arm will examine whether a twelve month treatment program (one year) enrolled with their Care-receivers( SCI individuals) can lower body weight, reduce body fat, reduce risk factors for developing heart disease and diabetes, and improve the quality of life using a 6 months of structured lifestyle intervention incorporating education, exercise, diet, and behavioral support.
Group III: Caregiver Control (CC)Placebo Group1 Intervention
Placebo: This arm will examine whether a twelve month treatment program (one year) enrolled with their Care-receivers( SCI individuals) can lower body weight, reduce body fat, reduce risk factors for developing heart disease and diabetes, and improve the quality of life. The control group intervention will test benefits of exercise alone while controlling for investigator contact.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Spinal Cord Injury (SCI)
2016
N/A
~30

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor
901 Previous Clinical Trials
409,964 Total Patients Enrolled
National Institute on Disability, Independent Living, and Rehabilitation ResearchFED
71 Previous Clinical Trials
9,107 Total Patients Enrolled
Mark S Nash, PhDPrincipal InvestigatorUniversity of Miami
11 Previous Clinical Trials
392 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Lifestyle Intervention Targeting Enhanced Health and Function for Persons With Chronic SCI in Caregiver/Care-Receiver Relationships: Effects of Caregiver Co-Treatment
Mark S. Nash, Ph.D., FACSM 2016. "A Lifestyle Intervention Targeting Enhanced Health and Function for Persons With Chronic SCI in Caregiver/Care-Receiver Relationships: Effects of Caregiver Co-Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02853149.
~2 spots leftby Apr 2025
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