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Spinal Fusion and Rehabilitation Study

Outcome of Lumbar Spinal Fusion Patients and Significance of Postoperative Exercise Therapy: Randomized Controlled Trial and Spine Register Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00834015
Enrollment
100
Registered
2009-02-02
Start date
2010-05-31
Completion date
2012-12-31
Last updated
2015-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spondylolisthesis, Degenerative, Spondylolisthesis, Isthmic

Keywords

spinal fusion, pain, disability, muscle strength, mobility, quality of life, lumbar, isthmic or degenerative spondylolisthesis

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.

Interventions

OTHEROutcome of lumbar spinal fusion patients and significance of postoperative exercise therapy: A randomized controlled trial

combined strength and aerobic training group

Sponsors

Tampere University Hospital
CollaboratorOTHER
Tampere University
CollaboratorOTHER
Jyväskylä Central Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
painbaseline, 1 year (+ 1 year follow-up)visual analogue scale (VAS)
disabilitybaseline, 1 year (+ 1 year follow-up)
quality of lifebaseline, 1 year (+ 1 year follow-up)

Secondary

MeasureTime frameDescription
physical activitybaseline, 1 yearInternational Physical Activity Questionnaire (short form)
trunk muscle strengthbaseline, 1 yearisometric strength of flexor and extensor
depressive symptomsbaseline, 1 yearDEPS-scale
spine mobilitybaseline, 1 yearflexion tests and lateral bending test
fear of movementbaseline, 1 year postoperativelyTampa Scale for Kinesiophobia

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026