Spinal Fusion and Rehabilitation Study

Not Applicable

Completed

• Conditions: Spondylolisthesis, Degenerative; Spondylolisthesis, Isthmic

• Registration Number: NCT00834015
• Lead Sponsor: Jyväskylä Central Hospital

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.

Study Timeline

• Study First Submitted: 2009-01-30
• Study First Submitted QC: 2009-01-30
• Study First Posted: 2009-02-02
• Study Start: 2010-05
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-13
• Last Update Posted: 2015-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
pain	baseline, 1 year (+ 1 year follow-up)	visual analogue scale (VAS)
disability	baseline, 1 year (+ 1 year follow-up)
quality of life	baseline, 1 year (+ 1 year follow-up)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Jyväskylä Central Hospital; 🇫🇮 Jyväskylä, Finland