NCT01533805

Brief Summary

The purpose of this study is to compare different methods of application of the Pilates Method with exercises in controlling in low back pain in women aged between 45 and 60 years. Two groups will be formed. One will do Pilates exercises with stabilization segmental. The other group will do classic Pilates exercises. Will be measure pre and pos intervention of the responses already shown above.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Feb 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 2, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 15, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

February 15, 2012

Status Verified

February 1, 2012

Enrollment Period

7 months

First QC Date

February 2, 2012

Last Update Submit

February 14, 2012

Conditions

Keywords

LumbagoExercise therapySpine

Outcome Measures

Primary Outcomes (1)

  • Pain

    low back pain will be assessed with numeric pain scale two times (pre and post-intervention)

    Up to 8 weeks

Secondary Outcomes (3)

  • Endurance of the back extensor muscles

    Up to 8 weeks

  • Activity of abdominis transversus

    Up to 8 weeks

  • Functional Limitation

    Up to 8 weeks

Study Arms (2)

Pilates with stabilization

EXPERIMENTAL

This group will do pilates exercises with a focus on control of segmental stabilization of the lumbar spine neutral.

Other: Pilates exercises with stabilization

Classic Pilates

ACTIVE COMPARATOR

This group will make Pilates exercises its focus is on mobilization exercises of the lumbar spine.

Other: Classic Pilates

Interventions

This group will focus on exercises with core stabilizing muscles. The frequency will be 16 sessions lasting 1 hour.

Also known as: Pilates with stabilization segmental
Pilates with stabilization

This group will make Pilates exercises its focus is on mobilization exercises of the lumbar spine. The frequency will be 16 sessions lasting 1 hour.

Classic Pilates

Eligibility Criteria

Age45 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Chronic low back pain classified by visual analogue scale being 3-6 points to more than 3 weeks
  • Not be performing any other type of physical therapy

You may not qualify if:

  • Pregnant women
  • Back surgeries
  • Cardiovascular and rheumatic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gama Filho University

Rio de Janeiro, Rio de Janeiro, 23050-260, Brazil

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Cintia P Souza, bachelor

    University Gama Filho

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cintia P Souza, Bachelor

CONTACT

Elirez B Silva, Doctoral

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 2, 2012

First Posted

February 15, 2012

Study Start

February 1, 2012

Primary Completion

September 1, 2012

Study Completion

December 1, 2012

Last Updated

February 15, 2012

Record last verified: 2012-02

Locations