Spinal Fusion and Rehabilitation Study

Spondylolisthesis, Degenerative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00834015
• Other study ID #: Ksshp Dnro 4E/2008
• Secondary ID: Ksshp Dnro 4E/20
• Status: Completed
• Phase: N/A
• First received: January 30, 2009
• Last updated: April 13, 2015
• Start date: May 2010
• Est. completion date: December 2012

Study information

• Verified date: April 2015
• Source: Jyväskylä Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Spondylolisthesis
• Spondylolisthesis, Degenerative
• Spondylolisthesis, Isthmic

Intervention

Other:
• Outcome of lumbar spinal fusion patients and significance of postoperative exercise therapy: A randomized controlled trial
combined strength and aerobic training group

Locations

Country	Name	City	State
Finland	Jyväskylä Central Hospital	Jyväskylä

Sponsors (3)

Lead Sponsor	Collaborator
Jyväskylä Central Hospital	Tampere University Hospital, University of Tampere

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain	visual analogue scale (VAS)	baseline, 1 year (+ 1 year follow-up)	Yes
Primary	disability		baseline, 1 year (+ 1 year follow-up)	Yes
Primary	quality of life		baseline, 1 year (+ 1 year follow-up)	Yes
Secondary	trunk muscle strength	isometric strength of flexor and extensor	baseline, 1 year	Yes
Secondary	spine mobility	flexion tests and lateral bending test	baseline, 1 year	Yes
Secondary	fear of movement	Tampa Scale for Kinesiophobia	baseline, 1 year postoperatively	Yes
Secondary	physical activity	International Physical Activity Questionnaire (short form)	baseline, 1 year	Yes
Secondary	depressive symptoms	DEPS-scale	baseline, 1 year	Yes