NCT00987155

Brief Summary

  1. 1.Measurements of peak oxygen uptake (VO2peak) during passive leg cycling (PLC) combined with arm crank ergometry (ACE), leg vascular occlusion (100mmHg above systolic BP) combined with ACE, and FES isometric contractions combined with ACE in spinal cord injured (SCI). All the above mentioned parameters will be compared to Functional Electrical Stimulated (FES) lower extremity cycling combined with ACE (FEShybrid). The hypothesis is that VO2peak is significantly higher during FES hybrid cycling when compared to peak and submaximal PLC, leg vascular occlusion and ACE. But the values for VO2peak during FES isometric contractions combined with ACE is not significantly different from FES hybrid cycling.
  2. 2.Comparison of sub-maximal and peak VO2 values during arm crank (ACE) and wheelchair ergometry (WCE) in persons with spinal cord injury. The hypothesis is that wheelchair propulsion due to higher energy expenditure show higher work output and VO2peak than ACE.
  3. 3.Does 6 weeks of maximal strength training improve SCI subjects performance during WCE? WCE after 6 weeks maximal strength training is less strenuous owing to better work economy/ efficiency.
  4. 4.Effect from aerobic high intensity hybrid training on stroke volume (SV) and VO2peak in spinal cord injured men.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2007

Longer than P75 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

January 1, 2007

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 28, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 30, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

January 18, 2017

Status Verified

January 1, 2017

Enrollment Period

5.1 years

First QC Date

September 28, 2009

Last Update Submit

January 16, 2017

Conditions

Cardiovascular Disease

Keywords

Functional electrical stimulation cyclingarm crankwheelchairergometryparaplegiaspinal cord injuryexercise testing

Outcome Measures

Primary Outcomes (1)

  • Maximal oxygen uptake

    2 years

Secondary Outcomes (4)

  • Blood lactate

    2 years

  • Blood Pressure

    2 years

  • Perceived Exertion

    2 years

  • Generated power (W)

    2 years

Study Arms (1)

high intensity interval training

EXPERIMENTAL

8 weeks of high intensity 4 times 4 interval training at 85-90% of peak heart rate during hybrid cycling

Device: Ergometry

Interventions

ErgometryDEVICE

MetamaxII Cortex ergospirometry system (Cortex Biophysik GmbH, Germany). Arm cycling ergometer (Ergomed 840L, Siemens, GermanyMonark, Sweden), Electrically braked wheelchair ergometer (VP 100, Handisoft France)

Also known as: Sensor Medics Vmax Spectra 229 version 10. 1, ERGYS 2 Rehabilitation system, Lactate Pro LT-1710 Analyzer, Polar® accurex watch, Thigh cuffs Criticares NIBP with Riester Metpak manometer, Motionstim 8, Medel Electronics (isometric FES)
high intensity interval training

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Paraplegia, sensorimotor complete injury AIS A to motor complete, sensory incomplete AIS B. Chronic neurological state with stabile spontaneous recovery compared to baseline AIS. At least year since injury.
  • Be able to tolerate direct current stimulation in the means of FES
  • Living in Health region IV and V, Norway.

You may not qualify if:

  • Pacemaker (demand type)
  • Known cancer
  • Known pregnancy
  • Severe autonomic dysreflexia
  • Gross contractures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Olav University Hospital

Trondheim, Norway

Location

Related Publications (1)

  • Torhaug T, Brurok B, Hoff J, Helgerud J, Leivseth G. Arm Crank and Wheelchair Ergometry Produce Similar Peak Oxygen Uptake but Different Work Economy Values in Individuals with Spinal Cord Injury. Biomed Res Int. 2016;2016:5481843. doi: 10.1155/2016/5481843. Epub 2016 Apr 10.

    PMID: 27144169RESULT

MeSH Terms

Conditions

Cardiovascular DiseasesParaplegiaSpinal Cord Injuries

Interventions

Ergometry

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSpinal Cord DiseasesCentral Nervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Gunnar Leivseth, Professor MD

    National Taiwan Normal University

    PRINCIPAL INVESTIGATOR

  • Gisle Meyer

    St. Olavs Hospital

    STUDY DIRECTOR

  • Lars Jacob Stovner, Professor

    National Taiwan Normal University

    STUDY DIRECTOR

  • Jan Hoff, Professor

    National Taiwan Normal University

    PRINCIPAL INVESTIGATOR

  • Berit Brurok, MSc

    St. Olavs Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2009

First Posted

September 30, 2009

Study Start

January 1, 2007

Primary Completion

February 1, 2012

Study Completion

May 1, 2012

Last Updated

January 18, 2017

Record last verified: 2017-01

Locations

NO(1)