Clinical trial NCT03743077: Health in Individuals With a Spinal Cord Injury: a Prospective Study
Official title: Fitness and Health in Individuals With a Spinal Cord Injury: a Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Exercise
Respiratory training
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2018-11-15
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean Time (seconds) for T-shirt Test
timeFrame: Up to 16 weeks post-intervention
measure: Mean Time for Transfer Test
timeFrame: Up to 16 weeks post-intervention
measure: Sitting Balance Performance Protocol, 4-way Reach Test
timeFrame: Up to 16 weeks post-intervention
measure: Peak Force from Trunk Strength Test
timeFrame: Up to 16 weeks post-intervention
Secondary outcomes:
measure: Total Number of Respiratory Training Diaries Submitted
timeFrame: Up to 16 weeks post-intervention
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center-NYPH
state: New York
Study officials:
affiliation: Columbia University
name: Martha Sliwinski, PT, PhD, MA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leathem JM, Macht-Sliwinski M, Boak S, Courville A, Dearwater M, Gazi S, Scott A. Community exercise for individuals with spinal cord injury with inspiratory muscle training: A pilot study. J Spinal Cord Med. 2021 Sep;44(5):711-719. doi: 10.1080/10790268.2019.1655200. Epub 2019 Sep 16.