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

NCT03743077 | Completed

• 1 other identifier: AAAQ8226
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Keywords

Exercise; Respiratory training

Outcome Measures

Primary Outcomes (4)

• 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.

  Up to 16 weeks post-intervention

• 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.

  Up to 16 weeks post-intervention

• 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.

  Up to 16 weeks post-intervention

• 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.

  Up to 16 weeks post-intervention

Secondary Outcomes (1)

• Total Number of Respiratory Training Diaries Submitted

  Up to 16 weeks post-intervention

Study Arms (1)

Individuals with spinal cord injury

EXPERIMENTAL

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

Interventions

Exercise training including inspiratory muscle training BEHAVIORAL

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.

Individuals with spinal cord injury

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and older
• Individuals with spinal cord injury
• Medically stable
• Able to participate in the spinal mobility program

You may not qualify if:

• Individual with spinal cord injury who is medically unstable
• Cannot participate in an exercise program

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center-NYPH

New York, New York, 10032, United States

Location

Related Publications (1)

• 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.

  PMID: 31525136 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries; Motor Activity

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Behavior

Study Officials

• Martha Sliwinski, PT, PhD, MA

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Rehabilitation and Regenerative Medicine

Study Record Dates

• First Submitted: November 13, 2018
• First Posted: November 15, 2018
• Study Start: September 10, 2016
• Primary Completion: November 1, 2017
• Study Completion: June 10, 2019
• Last Updated: January 27, 2021

Record last verified: 2021-01

Locations

US (1)