Effects of an Exercise Program Under Supervision and Unsupervised in the Treatment of Low Back

Study Overview
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Brief Summary
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ABSTRACT: Low back pain is one of the most frequent causes of incapacity. The prevalence of this syndrome is 60-85% for the survival of the individuals. Among the most promising strategies of low back pain intervention, is the physical activity that is usually associated with a long list of health benefits.

Detailed Description
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Purpose: evaluate the efficacy of a protocol of exercises to low back pain rehabilitation under supervision of physiatry service and rehabilitation in the Hospital de Clínicas de Porto Alegre compared with same protocol performed at home in regards to pain. Methods: Randomized clinical trial with a sample of 122 subjects of the community of both sex, with ages between 30 to 55, with low back pain complain. These subjects will accomplish during 12 weeks protocol of exercises from Exercises to low back pain Physiatry and Rehabilitation service from HCPA, randomized in two groups: group 1 will complete all the protocol of exercises with orientation and attendance directly from a professional of physical education, in the Service of Physiatry and Rehabilitation in HCPA. Group 2 will complete one session of the protocol of exercises with orientation and attendance directly from a professional of Physical Education, in the service of Physiatry and Rehabilitation of HCPA, to clarify any doubts about the protocol. The further sessions will be completed at home, along weekly monitoring of the researchers through phone calls, the patients of this group will receive a manual with the sequence of the exercises.

Official Title
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Effects of an Exercise Program Under Supervision and Unsupervised in the Treatment of Low Back Pain: a Randomized Clinical Trial

Conditions
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Low Back Pain

Intervention / Treatment
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* Other: Exercise protocol
* Other: Manual of exercises


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ages between 30 and 55 Pain should be without radiation to lower body Pain with more than 12 weeks of evolution. Visual Analog Scale of Pain (VAS) should present a pattern above 3 (moderate). Exclusion Criteria: Patients with Exclusion Criteria: will be excluded those patients that present musculoskeletal impairment in lower body, After surgery and anesthetic block. individuals affected with comorbidities Patients with rheumatic diseases, recent fractures, tumors, pregnant women, smokers and general practitioners of physical activity. Subjects who are unable to attend the hospital twice a week.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise protocol<br>Will complete all the protocol of exercises with orientation and attendance directly from a professional of physical education, in the Service of Physiatry and Rehabilitation in HCPA | Other: Exercise protocol<br>* Control group will complete all the protocol of exercises with orientation and attendance directly from a professional of physical education, in the Service of Physiatry and Rehabilitation in HCPA.<br>|
| Experimental: Manual of exercises<br>Treatment Group: will complete one session of the protocol of exercises with orientation and attendance directly from a professional of Physical Education, in the service of Physiatry and Rehabilitation of HCPA, to clarify any doubts about the protocol. The further sessions will be completed at home, along weekly monitoring of the researchers through phone calls, the patients of this group will receive a manual with the sequence of the exercises. | Other: Manual of exercises<br>* Treatment group will complete one session of the protocol of exercises with orientation and attendance directly from a professional of Physical Education, in the service of Physiatry and Rehabilitation of HCPA, to clarify any doubts about the protocol. The further sessions will be completed at home, along weekly monitoring of the researchers through phone calls, the patients of this group will receive a manual with the sequence of the exercises<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Pain Scale to asses Low Back Pain | Visual Analogue Pain Scale (EVA) - change from baseline pain after the intervention - evaluates the intensity of pain using a ruler divided into eleven equal parts, with a classification from 0 (painless) and 10 (maximum pain). | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-Form Survey (SF-36) to evaluate life quality | change from baseline in life quality after intervention -Survey with 36 items that measure 8 variable. | 24 months | 
| Six minutes walk-test - Functional capacity | Change from baseline in functional capacity ater intervention - measure the distance walked during 6 minutes. Performed in a corridor with a 30 meter distance with two cones in the extremities. | 24 months | 
| sit and reach test - flexibility | change from baseline in flexibility after intervention - individual in the sitting position with legs extended oriented move the marker on millimeter surface, held 3 times and considered the greatest value | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low back pain, physical exercise and quality of life