6 Minute Propulsion Test Sensitivity to Increased Aerobic Capacity

Spinal Cord Injury Clinical Trial

Official title:

6 Minute Propulsion Test Sensitivity to Increased Aerobic Capacity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01184729
• Other study ID #: TMP MN 002
• Status: Completed
• Phase: N/A
• First received: August 18, 2010
• Last updated: July 21, 2014
• Start date: November 2008
• Est. completion date: September 2013

Study information

• Verified date: July 2014
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The goals of this project are to 1)determine the responsiveness of the 6 Minute Push Test (6MPT) and 2) explore the relationship between 6MPT distance and measures of handicap, wheelchair satisfaction, depression, and self-reported avoidance of environmental features.

Description:

The 6 minute walk test is a widely used assessment of aerobic capacity, function, and functional change in the ambulatory population. A similar clinical and research outcome instrument that is responsive to changes in aerobic capacity and function are lacking for persons with spinal cord injury (SCI). A 6 minute push test, adapted from the 6 minute walk test may fill the void. The primary aim of this project is to assess if distance traveled in 6 minutes of wheelchair propulsion changes after an increase in aerobic capacity. We hypothesize that participants will push farther in 6 minutes after their aerobic capacity increases. The secondary aim is to explore the correlation between 6MPT distance and handicap, depression, wheelchair satisfaction, and self-reported avoidance of environmental features. We hypothesize increasing 6MPTdistance will be correlated with decreasing depression, decreasing handicap, decreasing self-reported avoidance of environmental features, and increasing wheelchair satisfaction. This is a low risk, high benefit study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• T1 or lower injury

• at least 1 year post-injury

• able to self-propel a manual wheelchair

• enrolled in TMP-MN-006

Exclusion Criteria:

• Not enrolled in the IRB approval parent study, "Exercise Treatment of Obesity-Related Secondary Conditions in Adults with Paraplegia", TMP-MN-006

• Unstable angina or myocardial infarction within the past month

• Resting heart rate >120

• Systolic blood pressure > 180 mm Hg

• Diastolic blood pressure > 100 mm Hg

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Locations

Country	Name	City	State
United States	The Miami Project to Cure Paralysis	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Oxygen uptake during 6 min Push Test From baseline.	Subjects will be prepared by putting a flexible mask over the mouth and nose. Heart rate during testing will be monitored by either three electrodes on the chest or by a monitor strapped around the chest. Heart rate and oxygen consumption during each 6MPT will be measured. Participants will be instructed to propel as far as possible on a 30m loop marked at 3m intervals, with 15m between pylons, and two 180 degree turns. Distance traveled in 6 minutes (m) will be computed by multiplying the number of full laps completed by 15m and adding the distance traveled in the last lap.	Visits 1-4	No

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