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

Not Applicable

Completed

• Conditions: Spinal Cord Injuries
• Interventions: Behavioral: Exercise training including inspiratory muscle training

• Registration Number: NCT03743077
• Lead Sponsor: Columbia University

Brief 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.

Detailed 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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2016-09-10
• Primary Completion: 2017-11-01
• Study First Submitted: 2018-11-13
• Study First Submitted QC: 2018-11-13
• Study First Posted: 2018-11-15
• Study Completion: 2019-06-10
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• 18 years and older
• Individuals with spinal cord injury
• Medically stable
• Able to participate in the spinal mobility program

Read More

Exclusion Criteria

• Individual with spinal cord injury who is medically unstable
• Cannot participate in an exercise program

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Individuals with spinal cord injury	Exercise training including inspiratory muscle training	Volunteers will participate in the the spinal mobility fitness training program which includes exercise training with inspiratory muscle training.

Primary Outcome Measures

Name	Time	Method
Peak Force from Trunk Strength Test	Up to 16 weeks post-intervention	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.
Mean Time (seconds) for T-shirt Test	Up to 16 weeks post-intervention	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.
Sitting Balance Performance Protocol, 4-way Reach Test	Up to 16 weeks post-intervention	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.
Mean Time for Transfer Test	Up to 16 weeks post-intervention	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.

Secondary Outcome Measures

Name	Time	Method
Total Number of Respiratory Training Diaries Submitted	Up to 16 weeks post-intervention	Compliance rate calculated by the total number of weekly sheets returned.

Trial Locations

Locations (1)

Columbia University Irving Medical Center-NYPH; 🇺🇸 New York, New York, United States