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

Cardiovascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00987155
• Other study ID #: 4.2007.2271
• Status: Completed
• Phase: N/A
• First received: September 28, 2009
• Last updated: January 16, 2017
• Start date: January 2007
• Est. completion date: May 2012

Study information

• Verified date: January 2017
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Spinal Cord Injuries

Intervention

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)

Locations

Country	Name	City	State
Norway	St Olav University Hospital	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Tørhaug 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: 10.1155/2016/54818 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal oxygen uptake		2 years
Secondary	Blood lactate		2 years
Secondary	Blood Pressure		2 years
Secondary	Perceived Exertion		2 years
Secondary	Generated power (W)		2 years