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

Primary Purpose

Spinal Cord Injuries

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise training including inspiratory muscle training
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Spinal Cord Injuries focused on measuring Exercise, Respiratory training

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Columbia University Irving Medical Center-NYPH

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Individuals with spinal cord injury

Arm Description

Volunteers will participate in the the spinal mobility fitness training program which includes exercise training with inspiratory muscle training.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Total Number of Respiratory Training Diaries Submitted
Compliance rate calculated by the total number of weekly sheets returned.

Full Information

First Posted
November 13, 2018
Last Updated
January 26, 2021
Sponsor
Columbia University
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1. Study Identification

Unique Protocol Identification Number
NCT03743077
Brief Title
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

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
September 10, 2016 (Actual)
Primary Completion Date
November 1, 2017 (Actual)
Study Completion Date
June 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
Exercise, Respiratory training

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Individuals with spinal cord injury
Arm Type
Experimental
Arm Description
Volunteers will participate in the the spinal mobility fitness training program which includes exercise training with inspiratory muscle training.
Intervention Type
Behavioral
Intervention Name(s)
Exercise training including inspiratory muscle training
Intervention Description
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 Measure Information:
Title
Mean Time (seconds) for T-shirt Test
Description
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.
Time Frame
Up to 16 weeks post-intervention
Title
Mean Time for Transfer Test
Description
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.
Time Frame
Up to 16 weeks post-intervention
Title
Sitting Balance Performance Protocol, 4-way Reach Test
Description
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.
Time Frame
Up to 16 weeks post-intervention
Title
Peak Force from Trunk Strength Test
Description
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.
Time Frame
Up to 16 weeks post-intervention
Secondary Outcome Measure Information:
Title
Total Number of Respiratory Training Diaries Submitted
Description
Compliance rate calculated by the total number of weekly sheets returned.
Time Frame
Up to 16 weeks post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martha Sliwinski, PT, PhD, MA
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Irving Medical Center-NYPH
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31525136
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.
Results Reference
derived

Learn more about this trial

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

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