Spinal Fusion and Rehabilitation Study

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

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).

Study Overview

• Status: Completed
• Conditions: Spondylolisthesis, Degenerative; Spondylolisthesis, Isthmic
• Intervention / Treatment: Other: Outcome of lumbar spinal fusion patients and significance of postoperative exercise therapy: A randomized controlled trial

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Jyväskylä, Finland, 40620
    • Jyväskylä Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Experimental; combined strength and aerobic training	Other: Outcome of lumbar spinal fusion patients and significance of postoperative exercise therapy: A randomized controlled trial; combined strength and aerobic training group; Other Names: Intervention group

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Jyväskylä Central Hospital
• Collaborators: Tampere University; Tampere University Hospital
• Investigators: Study Director: Arja Häkkinen, Professor, Department of Health Sciences, University of Jyväskylä; Principal Investigator: Marko Neva, Phd, MD, Tampere University Hospital; Principal Investigator: Keijo Häkkinen, professor, Department of Biology of Physical Activity, University of Jyväskylä; Principal Investigator: Joost Dekker, professor, Department of Rehabilitation Medicine, VU University Medical Center, Amsterdam, the Netherlands; Principal Investigator: Kimmo Vihtonen, Phd, MD, Department of Surgery, University of Tampere; Principal Investigator: Outi Ilves, Msc, PT, Department of Health Sciences University of Jyvaskyla

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: January 30, 2009
• First Submitted That Met QC Criteria: January 30, 2009
• First Posted (Estimate): February 2, 2009

Study Record Updates

• Last Update Posted (Estimate): April 14, 2015
• Last Update Submitted That Met QC Criteria: April 13, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: pain; quality of life; muscle strength; mobility; disability; lumbar; spinal fusion; isthmic or degenerative spondylolisthesis
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylolysis; Spondylosis; Spondylolisthesis
• Other Study ID Numbers: Ksshp Dnro 4E/2008 (Other Identifier: K-Sshp)