A Lifestyle Intervention Targeting Enhanced Health and Function for Persons With Chronic SCI in Caregiver/Care-Receiver Relationships: Effects of Caregiver Co-Treatment

Summary

This study determines in people with chronic SCI the health and functional impact and user acceptance and satisfaction - of a 6-month comprehensive Lifestyle Intervention; the impact and user acceptance/satisfaction of a Complementary Caregiver Curriculum (CCC) on SCI caregiver health and function and whether the complementary caregiver curriculum (CCC) enhances health and functional benefits obtained by the SCI dyadic partner enrolled in the LI program.

Conditions

• Spinal Cord Injury
• Cardiovascular Diseases
• Obesity

Interventions

BEHAVIORAL

Spinal Cord Injury (SCI)

The SCI Intervention group will undergo intense exercise, a defined nutrition program, and an educational program taught by the study investigators. The exercise will require them to undergo supervised activity 3 times weekly for 6 months. They will also participate in a series of educational sessions that examine their lifestyle, and modify exercise/nutritional habits. After 6 months they will advance to another 6 months or "extension phase" in which the investigators expect them to continue to exercise up to 3 times per week at our center or at home by using elastic exercise bands (Thera-band) and handles that the Investigators will provide and teach how to use. They will also be expected to continue the modified nutritional program.

BEHAVIORAL

Caregiver Intervention(CCC)

The Caregiver Intervention group will undergo intense exercise, a defined nutrition program, and an educational program taught by the study investigators. The exercise will require them to undergo supervised activity 3 times weekly for 6 months. They will also participate in a series of educational sessions that examine their lifestyle, and modify exercise/nutritional habits. After 6 months they will advance to another 6 months or "extension phase" in which the investigators expect them to continue to exercise up to 3 times per week at our center or at home by using elastic exercise bands (Thera-band) and handles that the Investigators will provide and teach how to use. They will also be expected to continue the modified nutritional program.

BEHAVIORAL

Caregiver Control (CC)

The Caregiver Control group will also discuss ways in which health and fitness can be improved through exercise and nutrition and will also be offered a fully paid membership to the an exercise fitness center to encourage them to exercise and consume a healthy diet. Unlike the Caregiver Intervention group(CCC) the lifestyle recommendations will be provided by internet authorities such as Web Medical(WebMD), the US Department of Agriculture, and the US Department of Human Health Services, which are dependable websites that promote healthy ways of living.

Sponsors & Collaborators

• National Institute on Disability, Independent Living, and Rehabilitation Research

  collaborator FED

• University of Miami

  lead OTHER

Principal Investigators

• Mark S Nash, PhD · University of Miami

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-06-26

Primary Completion

2022-09-23

Completion

2022-09-23

Countries

• United States

Study Locations