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

NCT ID: NCT00987155

Last Updated: 2017-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2012-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiovascular Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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high intensity interval training

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

Group Type EXPERIMENTAL

Ergometry

Intervention Type DEVICE

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

Interventions

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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)

Intervention Type DEVICE

Other Intervention Names

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Sensor Medics Vmax Spectra 229 version 10. 1 ERGYS 2 Rehabilitation system Lactate Pro LT-1710 Analyzer PolarĀ® accurex watch Thigh cuffs Criticares NIBP with Riester Metpak manometer Motionstim 8, Medel Electronics (isometric FES)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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St. Olavs Hospital

OTHER

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gunnar Leivseth, Professor MD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan Normal University

Gisle Meyer

Role: STUDY_DIRECTOR

St. Olavs Hospital

Lars Jacob Stovner, Professor

Role: STUDY_DIRECTOR

National Taiwan Normal University

Jan Hoff, Professor

Role: PRINCIPAL_INVESTIGATOR

National Taiwan Normal University

Berit Brurok, MSc

Role: PRINCIPAL_INVESTIGATOR

St. Olavs Hospital

Locations

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St Olav University Hospital

Trondheim, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type RESULT
PMID: 27144169 (View on PubMed)

Other Identifiers

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4.2007.2271

Identifier Type: -

Identifier Source: org_study_id

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