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Intervention Study to Assess the Effects of Moderate and High Intensity Aerobic Training on Physical Capacity and Activity Level in Persons With Incomplete Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT01903226
Recruitment Status : Completed
First Posted : July 19, 2013
Last Update Posted : April 19, 2018
Sponsor:
Information provided by (Responsible Party):
Matthijs Ferdinand Wouda, Sunnaas Rehabilitation Hospital

Brief Summary:
The aims of this study are to assess the effects of medium versus high intensity 12-week adjusted training programs on physical capacity in persons with incomplete SCI, early after discharge from primary rehabilitation, and to investigate if the training program induces a more active lifestyle in terms of increased daily energy expenditure.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Other: High intensity training Other: Moderate intensity training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: High Intensity Aerobic Training in Persons With Incomplete Spinal Cord Injury
Study Start Date : January 2013
Actual Primary Completion Date : January 2017
Actual Study Completion Date : April 2018

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Arm Intervention/treatment
Experimental: High intensity training
Patients in this group will perform high aerobic intensity training, in 30 minutes, twice a week, in a 12 week period.
Other: High intensity training
Experimental: Moderate intensity training
Patients in this group will perform moderate aerobic intensity training, in 45 minutes, three times a week, in a 12 week period.
Other: Moderate intensity training
No Intervention: controll
Patients in this group will perform no (additional) training.



Primary Outcome Measures :
  1. change in VO2peak [ Time Frame: 0 months, 3 months and 12 months ]
    Physical capacity (VO2peak) will be measured before intervention (baseline), after 3 months and after 1 year (12 months. Changes (from baseline) in VO2peak after 3 months and after one year is the primary outcome measure.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Spinal cord injury
  • incomplete lesion (classified as ASIA D)
  • admitted to Sunnaas Rehabilitation Hospital for primary rehabilitation,
  • able to walk for 5 minutes on the treadmill (without assistive aids) at 4 km/hour

Exclusion Criteria:

  • cardiovascular diseases
  • progressive diseases
  • severe psychiatric conditions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01903226


Locations
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Norway
Sunnaas Rehabilitation Hospital
Nesoddtangen, Norway, 1450
Sponsors and Collaborators
Sunnaas Rehabilitation Hospital

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Responsible Party: Matthijs Ferdinand Wouda, PhD candidate, Sunnaas Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT01903226     History of Changes
Other Study ID Numbers: SPREK
First Posted: July 19, 2013    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: April 2018

Keywords provided by Matthijs Ferdinand Wouda, Sunnaas Rehabilitation Hospital:
spinal cord injury
physical capacity
energy expenditure
training

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