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Spinal Fusion and Rehabilitation Study

This study has been completed.
Sponsor:
Collaborators:
Tampere University Hospital
University of Tampere
Information provided by (Responsible Party):
Mirja Vuorenmaa, Jyväskylä Central Hospital
ClinicalTrials.gov Identifier:
NCT00834015
First received: January 30, 2009
Last updated: March 4, 2013
Last verified: March 2013
History of Changes
  Purpose

The aim of the present study is to analyse the significance of postoperative combined strength and aerobic training for outcome of the lumbar fusion patients compared to usual care (patients with isthmic or degenerative spondylolisthesis).


Condition Intervention
Spondylolisthesis, Degenerative
Spondylolisthesis, Isthmic
 Other: Outcome of lumbar spinal fusion patients and significance of postoperative exercise therapy: RCT

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Outcome of Lumbar Spinal Fusion Patients and Significance of Postoperative Exercise Therapy: Randomized Controlled Trial and Spine Register Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Jyväskylä Central Hospital:

Primary Outcome Measures:
  • pain [ Time Frame: baseline, 3 months, 1 year (+ 1 year follow-up) ] [ Designated as safety issue: Yes ]
    visual analoque scale (VAS)

  • Disability [ Time Frame: baseline, 3 months, 1 year (+ 1 year follow-up) ] [ Designated as safety issue: Yes ]
  • quality of life [ Time Frame: baseline, 3 months, 1 year (+ 1 year follow-up) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • trunk muscle strength [ Time Frame: baseline, 3 and 12 months postoperatively ] [ Designated as safety issue: Yes ]
    isometric strength of flexor and extensor


Enrollment: 100
Study Start Date: May 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental
combined strength and aerobic training
 Other: Outcome of lumbar spinal fusion patients and significance of postoperative exercise therapy: RCT
combined strength and aerobic training group
Other Name: Intervention group

Detailed Description:

Most of the studies published so far about lumbar fusion surgery have been interested in surgical procedure itself or in comparison of conservative or operative treatment. Less information is available about long-term outcome and exercise programs for operated patients. Therefore the investigators have developed "Spine fusion register", which include data on surgery procedure and outcome (pain, disability, back muscle function, quality of life, working capacity, reoperations and complications etc.) before and after surgery up to 5 years (started in January 1st, 2008). The main purpose of the present study is to analyze the significance of 12-month strength and aerobic training for outcome of the lumbar fusion patients compared to usual care. Patients (N=100) with lumbar fusion because of isthmic or degenerative olisthesis will be will be stratified by catchments area and randomized into combined strength and aerobic training group or into the control group.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • over 20 years old
  • isthmic or degenerative spondylolisthesis

Exclusion Criteria:

  • cardiovascular or musculoskeletal diseases, which may exclude their ability to perform strength and endurance training and testing
  • metabolic bone disease
  • psychosocial instability
  • malignant disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00834015

Locations
Finland
Jyväskylä Central Hospital
Jyväskylä, Finland, 40620
Sponsors and Collaborators
Jyväskylä Central Hospital
Tampere University Hospital
University of Tampere
Investigators
Study Director: Arja Häkkinen, Professor Department of Health Sciences, University of Jyväskylä
Principal Investigator: Marko Neva, Phd, MD Tampere University Hospital
Principal Investigator: Keijo Häkkinen, professor Department of Biology of Physical Activity, University of Jyväskylä
Principal Investigator: Joost Dekker, professor Department of Rehabilitation Medicine, VU University Medical Center, Amsterdam, the Netherlands
Principal Investigator: Kimmo Vihtonen, Phd, MD Department of Surgery, University of Tampere
  More Information

No publications provided by Jyväskylä Central Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Mirja Vuorenmaa, physiotherapist, Jyväskylä Central Hospital
ClinicalTrials.gov Identifier: NCT00834015     History of Changes
Other Study ID Numbers: Ksshp Dnro 4E/2008, Ksshp Dnro 4E/2008
Study First Received: January 30, 2009
Last Updated: March 4, 2013
Health Authority: Finland: Ethics Committee

Keywords provided by Jyväskylä Central Hospital:
spinal fusion
pain
disability
muscle strength
 mobility
quality of life
lumbar
isthmic or degenerative spondylolisthesis

Additional relevant MeSH terms:
Spondylolisthesis
Spondylolysis
Spondylosis
 Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on June 17, 2013