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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Lumbar Spine Fusion

Intervention / Treatment
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* Behavioral: The training group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The training group<br>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. | Behavioral: The training group<br>* 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.<br>|
| No Intervention: The control group<br>The control group followed the hospital's standard protocol. These do not include exercises or physiotherapy before 3 months after surgery. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of isometric trunk muscle strength | 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. | Baseline, 9 weeks and 18 months. | 
| Change of low back pain disability as measured by the Oswestry Disability Index | 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. | Baseline, 9 weeks and 18 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of walking distance as measured by the 6-min walking test | The walked distance was measured. A higher values represent a better outcome. The scale range was from 40m to 800m. | Baseline, 9 weeks and 18 months. | 
| Change the repetition of stand-ups during the Chair stand test. | A number of stand-ups in 30 seconds. A higher values represent a better outcome. The scale range was from 1 to 29 repetitions. | Baseline, 9 weeks and 18 months. | 
| Change of height as measured by the Standing reach height test. | A height which someone can reach. A higher values represent a better outcome. The scale range was from 190cm to 236cm. | Baseline, 9 weeks and 18 months. | 
| Change of Intra-abdominal pressure pre-activation pattern. | 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. | Baseline, 9 weeks and 18 months. | 
| Change of pain disability as measured by the Visual Analogue Scale. | 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. | Baseline, 9 weeks and 18 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rehabilitation, randomized controlled trial, strength training, early initiation, intra-abdominal pressure