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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03743077
Enrollment
12
Registered
2018-11-15
Start date
2016-09-10
Completion date
2019-06-10
Last updated
2021-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injuries

Keywords

Exercise, Respiratory training

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.

Interventions

BEHAVIORALExercise 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.

Sponsors

Columbia University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Mean Time (seconds) for T-shirt TestUp to 16 weeks post-interventionThis 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.
Mean Time for Transfer TestUp to 16 weeks post-interventionSubjects 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.
Sitting Balance Performance Protocol, 4-way Reach TestUp to 16 weeks post-interventionMeasurements 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.
Peak Force from Trunk Strength TestUp to 16 weeks post-interventionParticipants 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.

Secondary

MeasureTime frameDescription
Total Number of Respiratory Training Diaries SubmittedUp to 16 weeks post-interventionCompliance rate calculated by the total number of weekly sheets returned.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026