6 Minute Propulsion Test Sensitivity to Increased Aerobic Capacity

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mark S. Nash, Ph.D., FACSM, University of Miami
ClinicalTrials.gov Identifier:
NCT01184729
First received: August 18, 2010
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

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.


Condition
Spinal Cord Injury

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: 6 Minute Propulsion Test Sensitivity to Increased Aerobic Capacity

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Change in Oxygen uptake during 6 min Push Test From baseline. [ Time Frame: Visits 1-4 ] [ Designated as safety issue: No ]
    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.


Enrollment: 27
Study Start Date: November 2008
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Spinal Cord Injury

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Community sample of persons with spinal cord injury

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01184729

Locations
United States, Florida
The Miami Project to Cure Paralysis
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Investigators
Principal Investigator: Mark S Nash, PhD University of Miami, The Miami Project to Cure Paralysis
  More Information

Additional Information:
No publications provided

Responsible Party: Mark S. Nash, Ph.D., FACSM, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT01184729     History of Changes
Other Study ID Numbers: TMP MN 002
Study First Received: August 18, 2010
Last Updated: July 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Miami:
aerobic capacity

Additional relevant MeSH terms:
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on August 28, 2014