Spinal Fusion and Rehabilitation Study
Outcome of Lumbar Spinal Fusion Patients and Significance of Postoperative Exercise Therapy: Randomized Controlled Trial and Spine Register Study
1 other identifier
interventional
100
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 30, 2009
CompletedFirst Posted
Study publicly available on registry
February 2, 2009
CompletedStudy Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedApril 14, 2015
April 1, 2015
2.6 years
January 30, 2009
April 13, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
pain
visual analogue scale (VAS)
baseline, 1 year (+ 1 year follow-up)
disability
baseline, 1 year (+ 1 year follow-up)
quality of life
baseline, 1 year (+ 1 year follow-up)
Secondary Outcomes (5)
trunk muscle strength
baseline, 1 year
spine mobility
baseline, 1 year
fear of movement
baseline, 1 year postoperatively
physical activity
baseline, 1 year
depressive symptoms
baseline, 1 year
Study Arms (1)
Experimental
OTHERcombined strength and aerobic training
Interventions
combined strength and aerobic training group
Eligibility Criteria
You may qualify if:
- over 20 years old
- isthmic or degenerative spondylolisthesis
You may not qualify if:
- cardiovascular or musculoskeletal diseases, which may exclude their ability to perform strength and endurance training and testing
- metabolic bone disease
- psychosocial instability
- malignant disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jyväskylä Central Hospitallead
- Tampere University Hospitalcollaborator
- Tampere Universitycollaborator
Study Sites (1)
Jyväskylä Central Hospital
Jyväskylä, 40620, Finland
Related Publications (1)
Tarnanen S, Neva MH, Dekker J, Hakkinen K, Vihtonen K, Pekkanen L, Hakkinen 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.
PMID: 22817607DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
- PRINCIPAL INVESTIGATOR
Outi Ilves, Msc, PT
Department of Health Sciences University of Jyvaskyla
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 30, 2009
First Posted
February 2, 2009
Study Start
May 1, 2010
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
April 14, 2015
Record last verified: 2015-04