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Completed

NCT Number: NCT00834015

Spinal Fusion and Rehabilitation 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).

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jyväskylä Central Hospital

Jyväskylä, 40620, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

combined strength and aerobic training group

Other names: Intervention group

Primary outcomes

  1. pain

    Time frame: baseline, 1 year (+ 1 year follow-up)

    visual analogue scale (VAS)

  2. disability

    Time frame: baseline, 1 year (+ 1 year follow-up)

  3. quality of life

    Time frame: baseline, 1 year (+ 1 year follow-up)

Secondary outcomes

  1. trunk muscle strength

    Time frame: baseline, 1 year

    isometric strength of flexor and extensor

  2. spine mobility

    Time frame: baseline, 1 year

    flexion tests and lateral bending test

  3. fear of movement

    Time frame: baseline, 1 year postoperatively

    Tampa Scale for Kinesiophobia

  4. physical activity

    Time frame: baseline, 1 year

    International Physical Activity Questionnaire (short form)

  5. depressive symptoms

    Time frame: baseline, 1 year

    DEPS-scale

Sponsors and collaborators

Lead sponsor

Jyväskylä Central Hospital

Other

Collaborators

  • Tampere University
  • Tampere University Hospital

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Feb 2, 2009
Registry last updated
Apr 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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