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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00987155
First received: September 28, 2009
Last updated: February 3, 2012
Last verified: February 2012
History of Changes
  Purpose
  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.


Condition Intervention Phase
Cardiovascular Disease
 Device: Ergometry
 Phase 0

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Spinal Cord Injury: Endurance, Strength and Cardiac Function Induced by Efficient Training Protocols

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Maximal oxygen uptake [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood lactate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Blood Pressure [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Perceived Exertion [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Generated power (W) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: January 2007
Estimated Study Completion Date: May 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00987155

Locations
Norway
St Olav University Hospital
Trondheim, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Investigators
Principal Investigator: Gunnar Leivseth, Professor MD NTNU
Study Director: Gisle Meyer St. Olavs Hospital
Study Director: Lars Jacob Stovner, Professor NTNU
Principal Investigator: Jan Hoff, Professor NTNU
Principal Investigator: Berit Brurok, MSc St. Olavs Hospital
  More Information

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00987155     History of Changes
Other Study ID Numbers: 4.2007.2271
Study First Received: September 28, 2009
Last Updated: February 3, 2012
Health Authority: Norway: Norwegian Social Science Data Services

Keywords provided by Norwegian University of Science and Technology:
Functional electrical stimulation cycling
arm crank
wheelchair
ergometry
 paraplegia
spinal cord injury
exercise testing

Additional relevant MeSH terms:
Cardiovascular Diseases
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
 Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on June 18, 2013