The Effects of Different Exercise Approaches in Patients With Chronic Low Back Pain

Study Overview
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Brief Summary
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Identification of the effects of yoga, stabilization exercise and aerobic exercise approaches on physical and cognitive variables in individuals with low back pain.

Detailed Description
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Patients participating in the study were divided three parallel groups. The patients in the stabilization exercise group were instructed to perform spinal stabilization exercises, the patients in the yoga group were instructed to perform yoga program consisting of breathing, relaxation and flexibility exercises. The patients in the aerobic exercise group were instructed to perform aerobic walking training. The severity of the pain evaluated through visual analog scale, functional status and quality of life, alexithymia, kinesiophobia, catastrophic pain, back awareness, cognitive function evaluated through Oswestry Disability Index(ODI), Nottingham Health Profile (NHP), Toronto Alexithymia Scale, Fear Avoidance Beliefs Questionnaire, Pain Catastrophizing Scale, Fremantle Back Awareness Scale, Montreal Cognitive Assessment respectively. Assessments were repeated before and after the treatment.

Official Title
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The Effects of Different Exercise Approaches on Physical and Cognitive Variables in Patients With Chronic Low Back Pain

Conditions
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Chronic Low-back Pain

Intervention / Treatment
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* Other: Yoga exercise program
* Other: Spinal stabilization exercise program
* Other: Aerobic walking program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non-specific low back pain Must be pain at least 3 months Exclusion Criteria: History of any lumbar spine surgery Presence of neurological deficit Having been diagnosed with cardiovascular or systemic diseases that would prevent him / her from taking exercise training. The presence of persistent severe pain Pain below the knee Severe/progressive scoliosis Spinal stenosis Spondylolisthesis Cancer Diabetes Metabolic syndrome Inflammatory, infectious or tumoral disease of the vertebra

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 55 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Yoga exercise group<br>Yoga program were applied all patients in this group accompanied by physiotherapist. Sessions included selected breathing, warm up and relaxation exercises. | Other: Yoga exercise program<br>* Yoga exercise program will be applied two sessions per week, totally eight week.<br>|
| Active Comparator: Spinal stabilization exercise group<br>Spinal stabilization exercise with three different progressive phases were applied all patients in this group accompanied by physiotherapist. | Other: Spinal stabilization exercise program<br>* Spinal stabilization exercise program will be applied two sessions per week, totally eight week.<br>|
| Active Comparator: aerobic walking exercise group<br>Aerobic walking exercise program applied all patients in this group accompanied by physiotherapist. | Other: Aerobic walking program<br>* Aerobic walking program will be applied two sessions per week, totally eight week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in pain severity | Patients' average resting, activity and night pain intensities assessed by Visual Analog Scale. The visual analog scale is an 11-point scale ranging from 0 to 10, in which 0 defines absence of pain and 10 describes unbearable pain. Participants asked to rate the average pain levels a horizontal 10 cm straight line on a white sheet from, before and after treatment. | change from baseline in pain severity at 8 weeks | 
| Changes of functional status | Patient's permanent functional disability measured by Oswestry Disability Index. The scale is considered the 'gold standard' of low back functional outcome tools. This scale contain questions related to functional activities of pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life and travelling.Interpretation of scale are 0% to 20% for minimal disability, 21% to 40% for moderate disability, 41 % to 60 % for severe disability 61% to 80 % for crippled and 81 % to 100 % Bed-bound. | change from baseline in functional status at 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in quality of life | Health-related quality of life assessed by Nottingham Health Profile (NHP). The NHP contain 38 questions in 6 subareas: pain, physical abilities, energy level, sleep, social isolation and emotional reaction. The scores range from 0 to 100, with each question assigned a weighted value; the sum of all weighted values in a given subarea adds up to 100. Lower scores denoting a better quality of life. | Change from baseline in life quality levels at 8 weeks | 
| Changes in gait parameters | Gait assessment will be recorded with OptoGait for one minute while participants walked their preferred speed on the treadmill. Patients asked to walk on level surface. Assessment were recorded during one minute. | Change from baseline in gait parameters at 8 weeks | 
| Changes in metabolic capacity | Metabolic capacity testing will be performed according to the Modified Bruce protocol on the Treadmill. At 3 minute intervals, the inclination increase by %2 with a concomitant increase in speed. | Change from baseline in metabolic capacity at 8 weeks | 
| Changes in cognitive level | The Montreal Cognitive Assessment Questionnaire (MoCA) will be used to assess the cognitive levels of individuals. MoCA was developed as a rapid screening test for mild cognitive impairment. MoCA assesses various cognitive functions such as attention and concentration, creative functions, memory, language, visual structuring skills, abstract thinking, computation and orientation. The application of MoCA takes about 10 minutes. The maximum total score of the test is 30. A score of 21 or above is considered normal. | Change from baseline in cognitive level at 8 weeks | 
| Changes in alexithymia | The alexithymia will be assessed by the Toronto Alexithymia Scale (TAS). The scale is a Likert-type self-assessment scale consisting of 20 items and scored between 1-5. Difficulties in recognizing emotions (TAS-1), difficulty in speaking emotions (TAS-2), extroverted thinking (TAS-3) subscales. The individual is asked to select the best option for each item from Never, Rarely, Sometimes, Often and Always. The higher the score, the higher the level of alexithymia. | Change from baseline in alexithymia at 8 weeks | 
| Changes in kinesiophobia. | Fear-Avoidance-Beliefs Questionnaire will be applied to evaluate kinesiophobia which is fear of movement due to low back pain.This questionnaire has 2 sub-sections related to physical activity and work. There are 4 questions scored in the physical activity section and 7 questions in the work section. 0-6 points are obtained for each question. The total score will be recorded. The higher the score, the higher the kinesiophobia. | Change from baseline in kinesiophobia at 8 weeks | 
| Changes in back awareness | The Fremantle Back Awareness Questionnaire will be used to evaluate how individuals perceive the back according to their body. The questionnaire includes 9 questions that measure how individuals perceive their back according to their body and how they perceive their body position. Questions is answered Likert type as 0 I never feel like this, 4 always or often feel like this. | Change from baseline in back awareness at 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aerobic, yoga, low back pain, exercise, cognitive