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

NCT ID: NCT03743077

Last Updated: 2021-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-10
• Study Completion Date: 2019-06-10

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.

Conditions

Spinal Cord Injuries

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Individuals with spinal cord injury

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

Group Type: EXPERIMENTAL

Exercise training including inspiratory muscle training

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Martha Sliwinski

Associate Professor of Rehabilitation and Regenerative Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martha Sliwinski, PT, PhD, MA

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Irving Medical Center-NYPH

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 31525136 (View on PubMed)

Other Identifiers

AAAQ8226

Identifier Type: -

Identifier Source: org_study_id