Physical Virtual Training for Older Women

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Universidade Gama Filho.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Renato Sobral Monteiro Junior, Universidade Gama Filho
ClinicalTrials.gov Identifier:
NCT01503203
First received: December 16, 2011
Last updated: December 29, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention
Low Back Pain
Other: Strength Training
Other: Core training
Other: Physical Virtual Training
Other: Core Training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Physical Virtual Training Effectiveness on Nonspecific Chronic Low Back Pain, Body Balance, Functional Autonomy and Mood of Older Women

Resource links provided by NLM:


Further study details as provided by Universidade Gama Filho:

Primary Outcome Measures:
  • Pain [ Time Frame: up to 8 weeks ] [ Designated as safety issue: No ]
    The low back pain will be assessed with numeric pain scale two times (pre and post-intervention).


Secondary Outcome Measures:
  • Body Balance [ Time Frame: up to 8 weeks ] [ Designated as safety issue: No ]
    The body balance will be assessed with Wii Balance Board two times (pre and post-intervention).

  • Functional autonomy [ Time Frame: up to 8 weeks ] [ Designated as safety issue: No ]
    The functional autonomy will be assessed with sit-to-stand test pre and post-intervention.

  • Mood [ Time Frame: up to 8 weeks ] [ Designated as safety issue: No ]
    The mood will be assessed with Profile of Mood State (POMS) two times (pre and post-intervention)


Estimated Enrollment: 39
Study Start Date: November 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: Physical Virtual Training
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.
Other: Strength 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 Name: Resistance training
Other: Core Training
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.
Other: Strength 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 Name: Resistance training
Other: Core training
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.

  Eligibility

Ages Eligible for Study:   65 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01503203

Contacts
Contact: Elirez B da Silva, Doctor 552125997183 elirezsilva@ugf.br
Contact: Renato S Monteiro Junior, Professor 552192447872 renatoprofedfis@hotmail.com

Locations
Brazil
Fisioprime Clinical of Physiotherapy Recruiting
Rio de Janeiro, Brazil, 555
Contact: Renato S Monteiro Junior, Professor    552192447872    renatoprofedfis@hotmail.com   
Principal Investigator: Renato S Monteiro Junior, Professor         
Sponsors and Collaborators
Universidade Gama Filho
Investigators
Study Director: Elirez B da Silva, Doctor Gama Filho University
  More Information

No publications provided

Responsible Party: Renato Sobral Monteiro Junior, Clinical Professor, Universidade Gama Filho
ClinicalTrials.gov Identifier: NCT01503203     History of Changes
Other Study ID Numbers: RSMJ20112
Study First Received: December 16, 2011
Last Updated: December 29, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Universidade Gama Filho:
Older
virtual systems
low back pain
postural balance

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on October 20, 2014