Health in Individuals With a Spinal Cord Injury: a Prospective Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03743077|
Recruitment Status : Completed
First Posted : November 15, 2018
Last Update Posted : January 27, 2021
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injuries||Behavioral: Exercise training including inspiratory muscle training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 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|
|Actual Primary Completion Date :||November 1, 2017|
|Actual Study Completion Date :||June 10, 2019|
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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|United States, New York|
|Columbia University Irving Medical Center-NYPH|
|New York, New York, United States, 10032|
|Principal Investigator:||Martha Sliwinski, PT, PhD, MA||Columbia University|