Spinal Cord Injury: Endurance, Strength and Cardiac Function Induced by Efficient Training Protocols

January 16, 2017 updated by: Norwegian University of Science and Technology
  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. 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. 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. Effect from aerobic high intensity hybrid training on stroke volume (SV) and VO2peak in spinal cord injured men.

8 weeks of high intensity 4 times 4 interval training at 85-90% of peak heart rate during hybrid cycling. Hypothesis; VO2peak and SV will be significantly increased from training.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway
        • St Olav University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: high intensity interval training
8 weeks of high intensity 4 times 4 interval training at 85-90% of peak heart rate during hybrid cycling
Device: Ergometry
MetamaxII Cortex ergospirometry system (Cortex Biophysik GmbH, Germany). Arm cycling ergometer (Ergomed 840L, Siemens, GermanyMonark, Sweden), Electrically braked wheelchair ergometer (VP 100, Handisoft France)
Other Names:
  • 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximal oxygen uptake
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Blood lactate
Time Frame: 2 years
2 years
Blood Pressure
Time Frame: 2 years
2 years
Perceived Exertion
Time Frame: 2 years
2 years
Generated power (W)
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

St. Olavs Hospital

Investigators

  • Principal Investigator: Gunnar Leivseth, Professor MD, National Taiwan Normal University
  • Study Director: Gisle Meyer, St. Olavs hospital
  • Study Director: Lars Jacob Stovner, Professor, National Taiwan Normal University
  • Principal Investigator: Jan Hoff, Professor, National Taiwan Normal University
  • Principal Investigator: Berit Brurok, MSc, St. Olavs hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

September 28, 2009

First Submitted That Met QC Criteria

September 29, 2009

First Posted (Estimate)

September 30, 2009

Study Record Updates

Last Update Posted (Estimate)

January 18, 2017

Last Update Submitted That Met QC Criteria

January 16, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4.2007.2271

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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