NCT01503203

Brief Summary

The purpose of this study will be assess the effectiveness of the physical virtual training on nonspecific chronic low back pain, body balance, functional autonomy and mood of older women. Two groups will be formed. One will do strength exercises and core training. The other group will do the same exercises more virtual activities with Nintendo Wii. Will be measure pre and post-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
39

participants targeted

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

Timeline
Completed

Started Nov 2011

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

November 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2011

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 2, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

January 2, 2012

Status Verified

December 1, 2011

Enrollment Period

5 months

First QC Date

December 16, 2011

Last Update Submit

December 29, 2011

Conditions

Keywords

Oldervirtual systemslow back painpostural balance

Outcome Measures

Primary Outcomes (1)

  • Pain

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

    up to 8 weeks

Secondary Outcomes (3)

  • Body Balance

    up to 8 weeks

  • Functional autonomy

    up to 8 weeks

  • Mood

    up to 8 weeks

Study Arms (2)

Wii Group

EXPERIMENTAL

This group will do the same training of the Prime Group. However will do also Physical Virtual Training using Nintendo Wii and Wii Balance Board. The physical virtual training going to applied during thirty minutes.

Other: Physical Virtual TrainingOther: Strength TrainingOther: Core Training

Prime Group

ACTIVE COMPARATOR

This group will do strength exercises and core training.

Other: Strength TrainingOther: Core training

Interventions

It will be does three times per week. The exercises are: squat, single leg squat, leg extension, leg curl, chair adductor, chair abductor and double plantar flexion.

Also known as: Resistance training
Prime Group

Exercises for trunk stabilization. Will be lateral, front and back bridges. It will be does three times per week with three sets between fifteen and third seconds.

Prime Group

The video game (Nintendo Wii and Wii Balance Board) will used for intervention. After strength and core training will be applied the physical virtual training during thirty minutes. Tho total time session for the Wii Group will be 110 minutes.

Wii Group

Eligibility Criteria

Age65 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • subjects with nonspecific chronic low back pain
  • patients without involvement in regular exercise program

You may not qualify if:

  • patients not recommended for physical exercise (Physical Activity Readiness Questionnaire PAR-Q)
  • trunk surgery
  • cancer
  • injuries in lower extremity
  • neurological or vestibular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fisioprime Clinical of Physiotherapy

Rio de Janeiro, Rio de Janeiro, 555, Brazil

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Elirez B da Silva, Doctor

    Gama Filho University

    STUDY DIRECTOR

Central Study Contacts

Elirez B da Silva, Doctor

CONTACT

Renato S Monteiro Junior, Professor

CONTACT

Study Design

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

Study Record Dates

First Submitted

December 16, 2011

First Posted

January 2, 2012

Study Start

November 1, 2011

Primary Completion

April 1, 2012

Study Completion

August 1, 2012

Last Updated

January 2, 2012

Record last verified: 2011-12

Locations