6 Minute Push & 30 Second Sprint Tests Reliability & Rela... | NCT01184742

Studies
6 Minute Push & 30 Second Sprint Tests Reliability & Relationship to Fitness, Participation, & Environmental Assessments

NCT01184742

Sponsor

University of Miami

Status

Completed

Last Update Posted

Jul 22, 2014Estimated

Enrollment

56Actual

Phase

Not provided

Conditions

Spinal Cord Injury

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2010

Primary Completion Date

Jan 2014Actual

Completion Date

Jan 2014Actual

First Submitted Date

Aug 18, 2010

First Submission Date that Met QC Criteria

Aug 18, 2010

First Posted Date

Aug 19, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 21, 2014

Last Update Posted Date

Jul 22, 2014Estimated

Name	Class
Paralyzed Veterans of America	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to assess the relationship between physical fitness and wheelchair mobility capacity and 1) participation; 2) self-reported environments barriers; and 3) self-reported avoidance of environmental features.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

56Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
6 Minute Push Test		Visit 3 and 4
30 Second Sprint Test		Visit 3 and 4

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

at least 1 year post-injury
able to self-propel a manual wheelchair
spinal cord injury between C5 and T5

Exclusion Criteria:

spinal cord injury above C5 or below T5
spinal cord injury severity of AIS D
unstable angina or myocardial infarction within the past month
resting heart rate >120
systolic blood pressure >180 mm Hg, or diastolic blood pressure >100 mm HG

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Community sample of persons with spinal cord injury.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mark S Nash, PhD	University of Miami, The Miami Project to Cure Paralysis	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Miami Project to Cure Paralysis		Miami	Florida	33136	United States

Condition Browse Module

MeSH Terms

ID	Term
D013119	Spinal Cord Injuries

Ancestor Terms

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D020196	Trauma, Nervous System

Browse Leaves

Not provided

Browse Branches

Not provided