NCT01184729

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 18, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 19, 2010

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

July 22, 2014

Status Verified

July 1, 2014

Enrollment Period

4.8 years

First QC Date

August 18, 2010

Last Update Submit

July 21, 2014

Conditions

Keywords

aerobic capacity

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Spinal Cord Injury

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Community sample of persons with spinal cord injury

You may qualify if:

  • T1 or lower injury
  • at least 1 year post-injury
  • able to self-propel a manual wheelchair
  • enrolled in TMP-MN-006

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Miami Project to Cure Paralysis

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Mark S Nash, PhD

    University of Miami, The Miami Project to Cure Paralysis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 18, 2010

First Posted

August 19, 2010

Study Start

November 1, 2008

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

July 22, 2014

Record last verified: 2014-07

Locations