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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02703402
Enrollment
122
Registered
2016-03-09
Start date
2016-03-31
Completion date
2018-03-31
Last updated
2016-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

Keywords

low back pain, physical exercise and quality of life

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.

Interventions

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.

OTHERManual 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

Sponsors

Hospital de Clinicas de Porto Alegre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
30 Years to 55 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Visual Analogue Pain Scale to asses Low Back Pain24 monthsVisual 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

MeasureTime frameDescription
Short-Form Survey (SF-36) to evaluate life quality24 monthschange from baseline in life quality after intervention -Survey with 36 items that measure 8 variable.
Six minutes walk-test - Functional capacity24 monthsChange 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 - flexibility24 monthschange 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

Contacts

Primary ContactLuciana Aparecida B. Piccoli, MD
lucianapiccolipersonal@gmail.com0555133597634
Backup ContactRosane M. Nery, PhD
rosane.nery@gmail.com0555133597634

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026