6 Minute Propulsion Test Sensitivity to Increased Aerobic Capacity

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.

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Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Miami Project to Cure Paralysis

Miami, Florida, 33136, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Change in Oxygen uptake during 6 min Push Test From baseline.

Time frame: Visits 1-4

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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Important dates

Study start: 2008
Primary completion: 2013
Study completion: 2013
First posted: Aug 19, 2010
Registry last updated: Jul 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed