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

Not Applicable

• Conditions: Low Back Pain
• Interventions: Other: Exercise protocol; Other: Manual of exercises

• Registration Number: NCT02703402
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2016-02-17
• Status Verified: 2016-03
• Study Start: 2016-03
• Study First Submitted QC: 2016-03-03
• Last Update Submitted: 2016-03-03
• Study First Posted: 2016-03-09
• Last Update Posted: 2016-03-09
• Primary Completion: 2018-03
• Study Completion: 2018-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 122

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise protocol	Exercise protocol	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
Manual of exercises	Manual of exercises	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.

Primary Outcome Measures

Name	Time	Method
Visual Analogue Pain Scale to asses Low Back Pain	24 months	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).

Secondary Outcome Measures

Name	Time	Method
Short-Form Survey (SF-36) to evaluate life quality	24 months	change from baseline in life quality after intervention -Survey with 36 items that measure 8 variable.
Six minutes walk-test - Functional capacity	24 months	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.
sit and reach test - flexibility	24 months	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