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

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ClinicalTrials.gov Identifier: NCT03743077
Recruitment Status : Recruiting
First Posted : November 15, 2018
Last Update Posted : November 15, 2018
Sponsor:
Information provided by (Responsible Party):
Martha Sliwinski, 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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Behavioral: Exercise training including inspiratory muscle training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Fitness and Health in Individuals With a Spinal Cord Injury: a Prospective Study
Actual Study Start Date : September 10, 2016
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Individuals with spinal cord injury
Volunteers will participate in the the spinal mobility fitness training program which includes exercise training with inspiratory muscle training.
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.




Primary Outcome Measures :
  1. Mean Time (seconds) for T-shirt Test [ Time Frame: 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.

  2. Mean Time for Transfer Test [ Time Frame: 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.

  3. Sitting Balance Performance Protocol, 4-way Reach Test [ Time Frame: 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.

  4. Peak Force from Trunk Strength Test [ Time Frame: 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.


Secondary Outcome Measures :
  1. Total Number of Respiratory Training Diaries Submitted [ Time Frame: Up to 16 weeks post-intervention ]
    Compliance rate calculated by the total number of weekly sheets returned.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03743077


Contacts
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Contact: Martha Sliwinski, PT, PhD ms2814@cumc.columbia.edu

Locations
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United States, New York
Columbia University Irving Medical Center-NYPH Recruiting
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
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Principal Investigator: Martha Sliwinski, PT, PhD, MA Columbia University

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Responsible Party: Martha Sliwinski, Associate Professor of Rehabilitation and Regenerative Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT03743077     History of Changes
Other Study ID Numbers: AAAQ8226
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Martha Sliwinski, Columbia University:
Exercise
Respiratory training

Additional relevant MeSH terms:
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Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System