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Completed

NCT Number: NCT03349580

Early Initiation of a Strength Training Based Rehabilitation After Lumbar Spine Fusion Improves Core Muscle Strength

To analyze safety and the effects of early initiation of the rehabilitation. Including the objective measurement outcomes after lumbar spine fusion, based on the principles of strength training.

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Key information

Conditions

Lumbar Spine Fusion

Age range

45 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The 27 patients were recruited for the study, aged 45 to 70 years, who had undergone lumbar spine fusion. The patients were randomized in to two groups. The strength training group started rehabilitation 3 weeks after surgery. The patients exercised two times per week, over 9 weeks. The focus was on muscle activation of lumbopelvic muscles stabilization. The control group followed a standard postoperative protocol, where no exercises were performed at the rehabilitation stage. The functional outcomes and the plain radiographs were evaluated after 3 weeks and subsequently after 3 and 18 months after the surgery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Primary diagnosis of degenerative, low-grade isthmic spondylolisthesis or degenerative disc disease with or without spinal stenosis.

Exclusion criteria

  • Previous lumbar fusion surgery, degenerative or idiopathic scoliosis, inflammatory disease, and history of malignancy.

Treatment and study plan

The training group

Behavioral

The training group performed rehabilitation program twice per week over 9 weeks. The group commenced rehabilitation 3 weeks after the surgery. During the phase one training (week 1 to week 5), the isometric exercises were preformed on the trunk extension, flexion and lateral flexion muscles. During the phase 2 (week 6 to week 9), the exercises were performed on the strength machines and duration of the exercises were maintained and prolonged to 30 seconds. The leg adduction and hip extension exercises were added. The patients were instructed to perform abdominal bracing (IAP) and maintain the neutral position of their lumbar spine before and during the exercises.

Primary outcomes

  1. Change of isometric trunk muscle strength

    Time frame: Baseline, 9 weeks and 18 months.

    The isometric trunk muscle extension, flexion and lateral flexion strength were measured using a strain-gauge dynamometer. Maximum torque was calculated from the force sensor data (Newton) and the lever as a distance between the middle line of the belt and the iliac crest level (meter). A higher values represent a better outcome. The scale range were 48 Nm -830 Nm for extension, 12 Nm - 1010 Nm for flexion, 35 Nm - 680 Nm for lateral flexion right and 16 Nm - 640 Nm for lateral flexion left.

  2. Change of low back pain disability as measured by the Oswestry Disability Index

    Time frame: Baseline, 9 weeks and 18 months.

    Self-reported levels of low back pain disability. The Oswestry Disability Index is presented as a score from 0 to 100 where lower scores represent lower levels of low back pain disability.

Secondary outcomes

  1. Change of walking distance as measured by the 6-min walking test

    Time frame: Baseline, 9 weeks and 18 months.

    The walked distance was measured. A higher values represent a better outcome. The scale range was from 40m to 800m.

  2. Change the repetition of stand-ups during the Chair stand test.

    Time frame: Baseline, 9 weeks and 18 months.

    A number of stand-ups in 30 seconds. A higher values represent a better outcome. The scale range was from 1 to 29 repetitions.

  3. Change of height as measured by the Standing reach height test.

    Time frame: Baseline, 9 weeks and 18 months.

    A height which someone can reach. A higher values represent a better outcome. The scale range was from 190cm to 236cm.

  4. Change of Intra-abdominal pressure pre-activation pattern.

    Time frame: Baseline, 9 weeks and 18 months.

    A lateral abdominal force sensor was used to estimate the time delay between the start of the increase in intra-abdominal pressure and the start of the force rise from the force plate (action start). The initiation of intra-abdominal pressure before starting the action contributed to better performance and result. The scale range was from -0.7s to 0.7s.

  5. Change of pain disability as measured by the Visual Analogue Scale.

    Time frame: Baseline, 9 weeks and 18 months.

    Self-reported levels of pain disability. The Visual Analogue Scale presents back pain intensity with scores from 0 to 10, where 0 = "no problems" and 10 = "maximum problems".

Sponsors and collaborators

Lead sponsor

Dejan Kernc

Other

Collaborators

  • Slovenian Research Agency
  • University Medical Centre Ljubljana
  • University of Ljubljana

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Nov 21, 2017
Registry last updated
Nov 24, 2017

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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