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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

January 30, 2009
March 4, 2013
May 2010
December 2012   (final data collection date for primary outcome measure)
  • 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 ]
pain disability quality of life [ Time Frame: preoprerative, 3 months, 1 year (+ 1 year follow-up) ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00834015 on ClinicalTrials.gov Archive Site
trunk muscle strength [ Time Frame: baseline, 3 and 12 months postoperatively ] [ Designated as safety issue: Yes ]
isometric strength of flexor and extensor
trunk muscle strength, mobility, fear avoidance, compliance [ Time Frame: preoperatively, 3 and 12 months postoperatively ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Spinal Fusion and Rehabilitation Study
Outcome of Lumbar Spinal Fusion Patients and Significance of Postoperative Exercise Therapy: Randomized Controlled Trial and Spine Register Study

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).

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
  • Spondylolisthesis, Degenerative
  • Spondylolisthesis, Isthmic
Other: Outcome of lumbar spinal fusion patients and significance of postoperative exercise therapy: RCT
combined strength and aerobic training group
Other Name: Intervention group
Experimental
combined strength and aerobic training
Intervention: Other: Outcome of lumbar spinal fusion patients and significance of postoperative exercise therapy: RCT
Tarnanen S, Neva MH, Dekker J, Häkkinen K, Vihtonen K, Pekkanen L, Häkkinen A. Randomized controlled trial of postoperative exercise rehabilitation program after lumbar spine fusion: study protocol. BMC Musculoskelet Disord. 2012 Jul 20;13:123. doi: 10.1186/1471-2474-13-123.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT00834015
Ksshp Dnro 4E/2008, Ksshp Dnro 4E/2008
No
Mirja Vuorenmaa, Jyväskylä Central Hospital
Jyväskylä Central Hospital
  • Tampere University Hospital
  • University of Tampere
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
Jyväskylä Central Hospital
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP