Skip to main content
Clinical Trials/NCT03207737
NCT03207737
Completed
N/A

A Blended Residential/Telehealth Lifestyle Intervention to Improve Cardiovascular Health and Manage Pain in Adults With Spinal Cord Injury.

University of Alabama at Birmingham1 site in 1 country23 target enrollmentSeptember 1, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Spinal Cord Injuries
Sponsor
University of Alabama at Birmingham
Enrollment
23
Locations
1
Primary Endpoint
Change in Warwick-Edinburgh Mental Well-Being Scale Score reflecting resilience
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The purpose of this study is to examine the effects of onsite and telehealth programs for individuals with spinal cord injury. The primary aim of this study is to compare the effectiveness of a blended 5-day onsite health promotion program followed by a 12-month telehealth package composed of exercise, nutrition, and mindfulness, to a 12-month telehealth-only package in individuals with spinal cord injury. The investigators hypothesize that the blended onsite and telehealth program will achieve better gains in fitness, dietary control, body composition, and pain management scores across a one-year period in comparison to the telehealth-only group. The secondary objective of this study is to examine changes in psychosocial mediators between the two groups to determine if key social cognitive theory constructs were significantly different between the two groups. The investigators hypothesize that the blended onsite and telehealth program will achieve better improvements in these outcomes compared to the telehealth only group.

Registry
clinicaltrials.gov
Start Date
September 1, 2017
End Date
April 30, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

James Rimmer

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

Inclusion Criteria

  • SCI ≥ 1 year post injury
  • Able to use arms for exercise
  • 18-60 years old
  • Reliable access to the internet
  • Ability to prepare own food, or have input into person responsible for food preparation
  • Can provide own self-care.

Exclusion Criteria

  • Cognitive impairment
  • Depression
  • Poorly controlled blood pressure (SBP ˃ 159 or DBP ˃ 95 mm HG)
  • Cardiovascular disease event within the past six months
  • Severe pulmonary disease
  • Renal failure
  • Current use of insulin or sulfonylurea agents
  • Current use of medications for psychosis or bipolar disorder
  • Active pressure ulcers

Outcomes

Primary Outcomes

Change in Warwick-Edinburgh Mental Well-Being Scale Score reflecting resilience

Time Frame: Change from baseline to 7 days post baseline to 1 year post baseline.

This scale measures resilience-A person's ability to understand, cope, adapt and strive for a positive balance between gains and losses in health and function across their lifespan.

Study Sites (1)

Loading locations...

Similar Trials