Spinal Fusion Study - Full Text View

Sponsors and Collaborators:	Jyväskylä Central Hospital TampereUH University of Tampere
Information provided by:	Jyväskylä Central Hospital
ClinicalTrials.gov Identifier:	NCT00834015

Purpose

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).

Condition	Intervention
Spinal Fusion	Other: Outcome of lumbar spinal fusion patients and significance of postoperative exercise therapy: RCT

MedlinePlus related topics: Exercise and Physical Fitness

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Outcome of Lumbar Spinal Fusion Patients and Significance of Postoperative Exercise Therapy: Randomized Controlled Trial and Spine Register Study

Further study details as provided by Jyväskylä Central Hospital:

Primary Outcome Measures:

pain disability quality of life [ Time Frame: preoprerative, 3 months, 1 year (+ 1 year follow-up) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

trunk muscle strength, mobility, fear avoidance, compliance [ Time Frame: preoperatively, 3 and 12 months postoperatively ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	March 2009
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental combined strength and aerobic training	Other: Outcome of lumbar spinal fusion patients and significance of postoperative exercise therapy: RCT combined strength and aerobic training group

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 we 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.

B. Spine

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

over 20 years
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00834015

Contacts

Contact: Arja Häkkinen, professor

358 14 260 4536

arja.hakkinen@jyu.fi

Sponsors and Collaborators

Jyväskylä Central Hospital

TampereUH

University of Tampere

Investigators

Study Director:	Arja Häkkinen, Professor	Department of Health Sciences, University of Jyväskylä
Principal Investigator:	Marko Neva, Phd, MD	TampereUH
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

More Information

No publications provided

Responsible Party:	Department of Health Sciences, University of Jyväskylä ( Arja Häkkinen )
Study ID Numbers:	Ksshp Dnro 4E/2008, Ksshp Dnro 4E/2008
Study First Received:	January 30, 2009
Last Updated:	January 30, 2009
ClinicalTrials.gov Identifier:	NCT00834015 History of Changes
Health Authority:	Finland: Ethics Committee

Keywords provided by Jyväskylä Central Hospital:

spinal fusion
pain
disability

muscle strength
mobility
quality of life

Study placed in the following topic categories:

Quality of Life
Pain

ClinicalTrials.gov processed this record on May 07, 2009