Health in Individuals With a Spinal Cord Injury: a Prospective Study

Spinal Cord Injuries Clinical Trial

Official title:

Fitness and Health in Individuals With a Spinal Cord Injury: a Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03743077
• Other study ID #: AAAQ8226
• Status: Completed
• Phase: N/A
• Start date: September 10, 2016
• Est. completion date: June 10, 2019

Study information

• Verified date: January 2021
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Individuals with a spinal cord injury need to exercise regularly to prevent the decline of health that results from a sedentary lifestyle. The purpose of this investigation is to examine the effects of a pre-existing exercise program and respiratory training on measures of health and quality of life in individuals who elect to participate in an existing 8-week supervised exercise program.

Description:

The life expectancy of individuals with spinal cord injuries (SCI) has increased over the past decade. Yet, this population continues to present with an increased risk of a number of secondary health conditions, many of which occur sooner and at a higher rate than the normative population. As a program established to address this post-rehabilitative exercise participation necessity, it is determined that the Spinal Mobility fitness program, if found effective, can have vast positive effects in addressing aspects of health, function fitness, and overall quality of life for individuals with SCI. In addition to the need for exercise respiratory training is an important component of prevention of illness in individuals with a spinal cord injury. Genitourinary, skin disease and respiratory disorders are the top 3 reasons. Developing effective respiratory training programs in addition to exercise programs are critical for the prevention of illness and enabling a high quality of life. Pneumonia and septicemia are the two leading causes of decreased life expectancy in this population. Adding respiratory training to the spinal mobility program would be an appropriate intervention to further prevent health decline in these individuals.The spinal mobility course runs for eight weeks two times each year for 8 sessions for 4 to 5 hours each on Saturdays. Additionally individuals can participate in spinal mobility fitness training up to 3 times a week for one to three hours.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 10, 2019
• Est. primary completion date: November 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years and older

• Individuals with spinal cord injury

• Medically stable

• Able to participate in the spinal mobility program

Exclusion Criteria:

• Individual with spinal cord injury who is medically unstable

• Cannot participate in an exercise program

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Behavioral:
• Exercise training including inspiratory muscle training
Volunteers will participate in the the spinal mobility fitness training program for a frequency of one to 3 times a week with pre and post tests including four objective measures of function (timed t-shirt test, timed transfer test, four direction reach test and trunk test of strength) and a pre and post subjective interview. In addition to the program consenting volunteers will perform inspiratory muscle training as a home program and submit weekly diaries tracking their training. The inspiratory muscle trainer by Respironics provides specific pressure for inspiratory muscle strength and endurance, regardless of how quickly or slowly patients breathe. It exercises respiratory muscles and improves breathing. It Improves muscle strength and is easy to use.

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center-NYPH	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Time (seconds) for T-shirt Test	This test is designed to measure seated stability, and ability to maintain stability when performing an upper extremity task common in every day activities. At all times there are two researchers ready to assist subject should they lose their balance. Each subject is given two trials per testing period, and the average time is recorded. Shorter times indicate better performance.	Up to 16 weeks post-intervention
Primary	Mean Time for Transfer Test	Subjects will execute transfer from and to the wheelchair in their normal fashion. They will be timed as they transferred to the mat table and from lying down back to the wheelchair. The time to perform these 2 tasks will be added as a single score. Each subject will perform 3 trials, and the mean time will be recorded.	Up to 16 weeks post-intervention
Primary	Sitting Balance Performance Protocol, 4-way Reach Test	Measurements for excursion with an out stretched arm in the forward, backward and left and right lateral directions using a yard stick from start to maximal reach will be recorded.	Up to 16 weeks post-intervention
Primary	Peak Force from Trunk Strength Test	Participants will instructed to sit in a posture that was as erect as possible. A hand held dynamometer (HHD) will be used to assess the strength. The HHD device will be placed between the examiner's hand and the participant's body with the force applied perpendicular to the trunk in four directions forward, backward, left and right. A second person will record the force values and guard the participant for safety purposes.	Up to 16 weeks post-intervention
Secondary	Total Number of Respiratory Training Diaries Submitted	Compliance rate calculated by the total number of weekly sheets returned.	Up to 16 weeks post-intervention