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Physical Virtual Training for Older Women

Primary Purpose

Low Back Pain

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Strength Training
Core training
Physical Virtual Training
Strength Training
Core Training
Sponsored by
Universidade Gama Filho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Older, virtual systems, low back pain, postural balance

Eligibility Criteria

65 Years - 75 Years (Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Fisioprime Clinical of PhysiotherapyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Wii Group

Prime Group

Arm Description

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.

This group will do strength exercises and core training.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Body Balance
The body balance will be assessed with Wii Balance Board two times (pre and post-intervention).
Functional autonomy
The functional autonomy will be assessed with sit-to-stand test pre and post-intervention.
Mood
The mood will be assessed with Profile of Mood State (POMS) two times (pre and post-intervention)

Full Information

First Posted
December 16, 2011
Last Updated
December 29, 2011
Sponsor
Universidade Gama Filho
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1. Study Identification

Unique Protocol Identification Number
NCT01503203
Brief Title
Physical Virtual Training for Older Women
Official Title
Physical Virtual Training Effectiveness on Nonspecific Chronic Low Back Pain, Body Balance, Functional Autonomy and Mood of Older Women
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Unknown status
Study Start Date
November 2011 (undefined)
Primary Completion Date
April 2012 (Anticipated)
Study Completion Date
August 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Gama Filho

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Older, virtual systems, low back pain, postural balance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
39 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Wii Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Prime Group
Arm Type
Active Comparator
Arm Description
This group will do strength exercises and core training.
Intervention Type
Other
Intervention Name(s)
Strength Training
Other Intervention Name(s)
Resistance training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Core training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Physical Virtual Training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Strength Training
Other Intervention Name(s)
Resistance training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Core Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain
Description
The low back pain will be assessed with numeric pain scale two times (pre and post-intervention).
Time Frame
up to 8 weeks
Secondary Outcome Measure Information:
Title
Body Balance
Description
The body balance will be assessed with Wii Balance Board two times (pre and post-intervention).
Time Frame
up to 8 weeks
Title
Functional autonomy
Description
The functional autonomy will be assessed with sit-to-stand test pre and post-intervention.
Time Frame
up to 8 weeks
Title
Mood
Description
The mood will be assessed with Profile of Mood State (POMS) two times (pre and post-intervention)
Time Frame
up to 8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: subjects with nonspecific chronic low back pain patients without involvement in regular exercise program Exclusion Criteria: patients not recommended for physical exercise (Physical Activity Readiness Questionnaire PAR-Q) trunk surgery cancer injuries in lower extremity neurological or vestibular disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elirez B da Silva, Doctor
Phone
552125997183
Email
elirezsilva@ugf.br
First Name & Middle Initial & Last Name or Official Title & Degree
Renato S Monteiro Junior, Professor
Phone
552192447872
Email
renatoprofedfis@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elirez B da Silva, Doctor
Organizational Affiliation
Gama Filho University
Official's Role
Study Director
Facility Information:
Facility Name
Fisioprime Clinical of Physiotherapy
City
Rio de Janeiro
ZIP/Postal Code
555
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renato S Monteiro Junior, Professor
Phone
552192447872
Email
renatoprofedfis@hotmail.com
First Name & Middle Initial & Last Name & Degree
Renato S Monteiro Junior, Professor

12. IPD Sharing Statement

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Physical Virtual Training for Older Women

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