Spinal Fusion and Rehabilitation Study

NCT ID: NCT00834015

Last Updated: 2015-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2012-12-31

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.

Conditions

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Spondylolisthesis, Degenerative Spondylolisthesis, Isthmic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Experimental

combined strength and aerobic training

Group Type OTHER

Outcome of lumbar spinal fusion patients and significance of postoperative exercise therapy: A randomized controlled trial

Intervention Type OTHER

combined strength and aerobic training group

Interventions

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Outcome of lumbar spinal fusion patients and significance of postoperative exercise therapy: A randomized controlled trial

combined strength and aerobic training group

Intervention Type OTHER

Other Intervention Names

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Intervention group

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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tampere University Hospital

OTHER

Sponsor Role collaborator

Tampere University

OTHER

Sponsor Role collaborator

Jyväskylä Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Arja Häkkinen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Arja Häkkinen, Professor

Role: STUDY_DIRECTOR

Department of Health Sciences, University of Jyväskylä

Marko Neva, Phd, MD

Role: PRINCIPAL_INVESTIGATOR

Tampere University Hospital

Keijo Häkkinen, professor

Role: PRINCIPAL_INVESTIGATOR

Department of Biology of Physical Activity, University of Jyväskylä

Joost Dekker, professor

Role: PRINCIPAL_INVESTIGATOR

Department of Rehabilitation Medicine, VU University Medical Center, Amsterdam, the Netherlands

Kimmo Vihtonen, Phd, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Surgery, University of Tampere

Outi Ilves, Msc, PT

Role: PRINCIPAL_INVESTIGATOR

Department of Health Sciences University of Jyvaskyla

Locations

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Jyväskylä Central Hospital

Jyväskylä, , Finland

Site Status

Countries

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Finland

References

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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.

Reference Type DERIVED
PMID: 22817607 (View on PubMed)

Other Identifiers

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Ksshp Dnro 4E/2008

Identifier Type: OTHER

Identifier Source: secondary_id

Ksshp Dnro 4E/2008

Identifier Type: -

Identifier Source: org_study_id

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