- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01503203
Physical Virtual Training for Older Women
December 29, 2011 updated by: Renato Sobral Monteiro Junior, Universidade Gama Filho
Physical Virtual Training Effectiveness on Nonspecific Chronic Low Back Pain, Body Balance, Functional Autonomy and Mood of Older Women
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
39
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Elirez B da Silva, Doctor
- Phone Number: 552125997183
- Email: elirezsilva@ugf.br
Study Contact Backup
- Name: Renato S Monteiro Junior, Professor
- Phone Number: 552192447872
- Email: renatoprofedfis@hotmail.com
Study Locations
-
-
-
Rio de Janeiro, Brazil, 555
- Recruiting
- Fisioprime Clinical of Physiotherapy
-
Contact:
- Renato S Monteiro Junior, Professor
- Phone Number: 552192447872
- Email: renatoprofedfis@hotmail.com
-
Principal Investigator:
- Renato S Monteiro Junior, Professor
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 75 years (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Wii Group
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.
|
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.
Other Names:
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.
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.
|
Active Comparator: Prime Group
This group will do strength exercises and core training.
|
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.
Other Names:
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain
Time Frame: up to 8 weeks
|
The low back pain will be assessed with numeric pain scale two times (pre and post-intervention).
|
up to 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body Balance
Time Frame: up to 8 weeks
|
The body balance will be assessed with Wii Balance Board two times (pre and post-intervention).
|
up to 8 weeks
|
Functional autonomy
Time Frame: up to 8 weeks
|
The functional autonomy will be assessed with sit-to-stand test pre and post-intervention.
|
up to 8 weeks
|
Mood
Time Frame: up to 8 weeks
|
The mood will be assessed with Profile of Mood State (POMS) two times (pre and post-intervention)
|
up to 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Elirez B da Silva, Doctor, Gama Filho University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2011
Primary Completion (Anticipated)
April 1, 2012
Study Completion (Anticipated)
August 1, 2012
Study Registration Dates
First Submitted
December 16, 2011
First Submitted That Met QC Criteria
December 29, 2011
First Posted (Estimate)
January 2, 2012
Study Record Updates
Last Update Posted (Estimate)
January 2, 2012
Last Update Submitted That Met QC Criteria
December 29, 2011
Last Verified
December 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RSMJ20112
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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