Clinical trial NCT00987155: Spinal Cord Injury: Endurance, Strength and Cardiac Function Induced by Efficient Training Protocols
Official title: Spinal Cord Injury: Endurance, Strength and Cardiac Function Induced by Efficient Training Protocols
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Keywords: Functional electrical stimulation cycling
arm crank
wheelchair
ergometry
paraplegia
spinal cord injury
exercise testing
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2009-09-30
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Maximal oxygen uptake
timeFrame: 2 years
Secondary outcomes:
measure: Blood lactate
timeFrame: 2 years
measure: Blood Pressure
timeFrame: 2 years
measure: Perceived Exertion
timeFrame: 2 years
measure: Generated power (W)
timeFrame: 2 years
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olav University Hospital
Study officials:
affiliation: National Taiwan Normal University
name: Gunnar Leivseth, Professor MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Olavs Hospital
name: Gisle Meyer
role: STUDY_DIRECTOR
affiliation: National Taiwan Normal University
name: Lars Jacob Stovner, Professor
role: STUDY_DIRECTOR
affiliation: National Taiwan Normal University
name: Jan Hoff, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Olavs Hospital
name: Berit Brurok, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.