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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

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

Timeline

Screening ~ 3 weeks3 visits

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline in Fitness indicators as measured by Body Mass index (BMI)-

Secondary study objectives

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 study objectives

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

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

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