Spinal Fusion and Rehabilitation Study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Spondylolisthesis, Degenerative, Spondylolisthesis, Isthmic

Intervention / Treatment
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* Other: Outcome of lumbar spinal fusion patients and significance of postoperative exercise therapy: A randomized controlled trial


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Experimental<br>combined strength and aerobic training | Other: Outcome of lumbar spinal fusion patients and significance of postoperative exercise therapy: A randomized controlled trial<br>* combined strength and aerobic training group<br>* Other names: Intervention group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| trunk muscle strength | isometric strength of flexor and extensor | baseline, 1 year | 
| spine mobility | flexion tests and lateral bending test | baseline, 1 year | 
| fear of movement | Tampa Scale for Kinesiophobia | baseline, 1 year postoperatively | 
| physical activity | International Physical Activity Questionnaire (short form) | baseline, 1 year | 
| depressive symptoms | DEPS-scale | baseline, 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spinal fusion, pain, disability, muscle strength, mobility, quality of life, lumbar, isthmic or degenerative spondylolisthesis