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

Not Applicable
Completed
Conditions
Lumbar Spine Fusion
Interventions
Behavioral: The training group
Registration Number
NCT03349580
Lead Sponsor
Dejan Kernc
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
27
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
The training groupThe training groupThe 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 Outcome Measures
NameTimeMethod
Change of isometric trunk muscle strengthBaseline, 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.

Change of low back pain disability as measured by the Oswestry Disability IndexBaseline, 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 Outcome Measures
NameTimeMethod
Change of walking distance as measured by the 6-min walking testBaseline, 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.

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

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

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

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

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