Spondylolisthesis, DegenerativeNCT00834015
Spinal Fusion and Rehabilitation Study
A study of Spondylolisthesis, Degenerative and Spondylolisthesis, Isthmic, run by Jyväskylä Central Hospital at 1 site in Finland.
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). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Spondylolisthesis, Degenerative, Spondylolisthesis, Isthmic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFinland
- Study dates
- May 2010to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- over 20 years old
- isthmic or degenerative spondylolisthesis
Who cannot join
- cardiovascular or musculoskeletal diseases, which may exclude their ability to perform strength and endurance training and testing
- metabolic bone disease
- psychosocial instability
- malignant disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Being tested
- Outcome of lumbar spinal fusion patients and significance of postoperative exercise therapy: A randomized controlled trial
- Keywords
- spinal fusion, pain, disability, muscle strength, mobility, quality of life, lumbar, isthmic or degenerative spondylolisthesis
- Medical subject headings
- Spondylolisthesis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outcome of lumbar spinal fusion patients and significance of postoperative exercise therapy: A randomized controlled trialOther
Also called Intervention group
combined strength and aerobic training group
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Other | combined strength and aerobic training Receives: Other: Outcome of lumbar spinal fusion patients and significance of postoperative exercise therapy: A randomized controlled trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain
visual analogue scale (VAS)
Measured: baseline, 1 year (+ 1 year follow-up)
disability
Measured: baseline, 1 year (+ 1 year follow-up)
quality of life
Measured: baseline, 1 year (+ 1 year follow-up)
Secondary outcomes (5)
trunk muscle strength
isometric strength of flexor and extensor
Measured: baseline, 1 year
spine mobility
flexion tests and lateral bending test
Measured: baseline, 1 year
fear of movement
Tampa Scale for Kinesiophobia
Measured: baseline, 1 year postoperatively
physical activity
International Physical Activity Questionnaire (short form)
Measured: baseline, 1 year
depressive symptoms
DEPS-scale
Measured: baseline, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2009 (estimated)
- Study startMay 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spondylolisthesis, DegenerativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jyväskylä Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University Hospital, Tampere University
- Responsible party
- Principal investigator, Arja Häkkinen, Jyväskylä Central Hospital
- Investigators
- Arja Häkkinen, Professor, Study director, Department of Health Sciences, University of JyväskyläMarko Neva, Phd, MD, Principal investigator, Tampere University HospitalKeijo Häkkinen, professor, Principal investigator, Department of Biology of Physical Activity, University of JyväskyläJoost Dekker, professor, Principal investigator, Department of Rehabilitation Medicine, VU University Medical Center, Amsterdam, the NetherlandsKimmo Vihtonen, Phd, MD, Principal investigator, Department of Surgery, University of TampereOuti Ilves, Msc, PT, Principal investigator, Department of Health Sciences University of Jyvaskyla
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00834015
- Sponsor's protocol ID
- Ksshp Dnro 4E/2008
- Other IDs
- Ksshp Dnro 4E/2008
- Status last verified
- Apr 2015
- First submitted
- 30 Jan 2009
- Last updated
- 14 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 22817607
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Lumbar Spinal Fusion Patients and Significance of Postoperative Exercise Therapy: Randomized Controlled Trial and Spine Register Study
- ClinicalTrials.gov ID
- NCT00834015
- Acronym / sponsor ID
- Ksshp Dnro 4E/2008
- Keywords
- spinal fusion, pain, disability, muscle strength, mobility, quality of life, lumbar, isthmic or degenerative spondylolisthesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Jyväskylä Central HospitalUniversity, hospital or other
- Collaborators
- Tampere University Hospital, Tampere University
- Study start
- May 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 2 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Other | Other: Outcome of lumbar spinal fusion patients and significance of postoperative exercise therapy: A randomized controlled trialcombined strength and aerobic training |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- over 20 years old
- isthmic or degenerative spondylolisthesis
Key exclusion criteria (4 listed)
- cardiovascular or musculoskeletal diseases, which may exclude their ability to perform strength and endurance training and testing
- metabolic bone disease
- psychosocial instability
- malignant disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Outcome of lumbar spinal fusion patients and significance of postoperative exercise therapy: A randomized controlled trialAlso: Intervention groupcombined strength and aerobic training group | Other | Experimental |
Primary outcome
pain
Time frame: baseline, 1 year (+ 1 year follow-up)
visual analogue scale (VAS)
disability
Time frame: baseline, 1 year (+ 1 year follow-up)
quality of life
Time frame: baseline, 1 year (+ 1 year follow-up)
5 secondary outcomes
trunk muscle strength
Time frame: baseline, 1 year
spine mobility
Time frame: baseline, 1 year
fear of movement
Time frame: baseline, 1 year postoperatively
physical activity
Time frame: baseline, 1 year
depressive symptoms
Time frame: baseline, 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2015.
- Derived from this study: PubMed 22817607Tarnanen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arja Häkkinen, Professor study director
Department of Health Sciences, University of Jyväskylä
Marko Neva, Phd, MD principal investigator
Tampere University Hospital
Keijo Häkkinen, professor principal investigator
Department of Biology of Physical Activity, University of Jyväskylä
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Spondylolisthesis, Degenerative and Spondylolisthesis, Isthmic, run by Jyväskylä Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain (time frame: baseline, 1 year (+ 1 year follow-up)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00834015, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2015.