Clinical trial NCT00834015: Spinal Fusion and Rehabilitation Study
Official title: Outcome of Lumbar Spinal Fusion Patients and Significance of Postoperative Exercise Therapy: Randomized Controlled Trial and Spine Register Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spondylolisthesis, Degenerative
Spondylolisthesis, Isthmic
Keywords: spinal fusion
pain
disability
muscle strength
mobility
quality of life
lumbar
isthmic or degenerative spondylolisthesis
Lead sponsor: Jyväskylä Central Hospital
Sponsor class: OTHER
Collaborators: name: Tampere University Hospital
name: Tampere University
First posted: 2009-02-02
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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).

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 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

Primary outcomes:
measure: pain
timeFrame: baseline, 1 year (+ 1 year follow-up)
measure: disability
timeFrame: baseline, 1 year (+ 1 year follow-up)
measure: quality of life
timeFrame: baseline, 1 year (+ 1 year follow-up)
Secondary outcomes:
measure: trunk muscle strength
timeFrame: baseline, 1 year
measure: spine mobility
timeFrame: baseline, 1 year
measure: fear of movement
timeFrame: baseline, 1 year postoperatively
measure: physical activity
timeFrame: baseline, 1 year
measure: depressive symptoms
timeFrame: baseline, 1 year
Other outcomes:
Locations:
city: Jyväskylä
country: Finland
facility: Jyväskylä Central Hospital
Study officials:
affiliation: Department of Health Sciences, University of Jyväskylä
name: Arja Häkkinen, Professor
role: STUDY_DIRECTOR
affiliation: Tampere University Hospital
name: Marko Neva, Phd, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Biology of Physical Activity, University of Jyväskylä
name: Keijo Häkkinen, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Rehabilitation Medicine, VU University Medical Center, Amsterdam, the Netherlands
name: Joost Dekker, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Surgery, University of Tampere
name: Kimmo Vihtonen, Phd, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Health Sciences University of Jyvaskyla
name: Outi Ilves, Msc, PT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.