NCT03284086

Brief Summary

This study compares peak oxygen uptake (VO2peak) and exercise efficiency in upper-body poling versus arm crank ergometry in trained able-bodied and paraplegic participants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable

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

September 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2017

Completed
Last Updated

September 15, 2017

Status Verified

September 1, 2017

Enrollment Period

8 months

First QC Date

September 13, 2017

Last Update Submit

September 13, 2017

Conditions

Keywords

Oxygen consumptionPhysical endurance

Outcome Measures

Primary Outcomes (1)

  • Peak oxygen uptake

    Peak oxygen uptake was measured during an incremental test to exhaustion.

    3 weeks

Study Arms (2)

paraplegic

OTHER

Well-trained participants with a spinal cord injury (\<Th1) were included in this group.

Diagnostic Test: upper-body double-polingDiagnostic Test: arm crank ergometry

able bodied

OTHER

Upper-body trained, able-bodied participants were included in this group.

Diagnostic Test: upper-body double-polingDiagnostic Test: arm crank ergometry

Interventions

An incremental peak test to exhaustion and four 5-min submaximal stages were performed in the upper-body double-poling mode.

able bodiedparaplegic
arm crank ergometryDIAGNOSTIC_TEST

An incremental peak test to exhaustion and four 5-min submaximal stages were performed in the arm crank ergometry mode.

able bodiedparaplegic

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • participants between the age of 18 and 50
  • well upper-body-trained participants with or without paraplegia

You may not qualify if:

  • people with injuries or sicknesses that might have impacted the testing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Elite Sports Research

Trondheim, Norway

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

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

Study Officials

  • Jorunn Helbostad, phd prof

    Dept of Neuromedicine and Movement Science, Norwegian University of Science and Technology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2017

First Posted

September 15, 2017

Study Start

September 1, 2016

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

September 15, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will share

All data will be de-identified by the project coordinator. The de-identified data will be stored on the NTNU server in a folder that only the JKB and ØS have access to. For analysing the data, parts of the de-identified data might be distributed amongst the four researchers and two master students linked to this study.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
September 2016-May 2017

Locations