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

Primary Purpose

Cardiovascular Disease

Status

Completed

Phase

Not Applicable

Locations

Norway

Study Type

Interventional

Intervention

Ergometry

About this trial

This is an interventional basic science trial for Cardiovascular Disease focused on measuring Functional electrical stimulation cycling, arm crank, wheelchair, ergometry, paraplegia, spinal cord injury, exercise testing

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

St Olav University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

high intensity interval training

Arm Description

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

Outcomes

Primary Outcome Measures

Maximal oxygen uptake

Secondary Outcome Measures

Blood lactate

Blood Pressure

Perceived Exertion

Generated power (W)

Full Information

NCT ID

NCT00987155

First Posted

September 28, 2009

Last Updated

January 16, 2017

Sponsor

Norwegian University of Science and Technology

Collaborators

St. Olavs Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00987155

Brief Title

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

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

January 2007 (undefined)

Primary Completion Date

February 2012 (Actual)

Study Completion Date

May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Norwegian University of Science and Technology

Collaborators

St. Olavs Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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. 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiovascular Disease

Keywords

Functional electrical stimulation cycling, arm crank, wheelchair, ergometry, paraplegia, spinal cord injury, exercise testing

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

high intensity interval training

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Ergometry

Other Intervention Name(s)

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)

Intervention Description

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

Primary Outcome Measure Information:

Title

Maximal oxygen uptake

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Blood lactate

Time Frame

2 years

Title

Blood Pressure

Time Frame

2 years

Title

Perceived Exertion

Time Frame

2 years

Title

Generated power (W)

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials: