Physical Virtual Training for Older Women

Low Back Pain Clinical Trial

Official title:

Physical Virtual Training Effectiveness on Nonspecific Chronic Low Back Pain, Body Balance, Functional Autonomy and Mood of Older Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01503203
• Other study ID #: RSMJ20112
• Status: Recruiting
• Phase: N/A
• First received: December 16, 2011
• Last updated: December 29, 2011
• Start date: November 2011
• Est. completion date: August 2012

Study information

• Verified date: December 2011
• Source: Universidade Gama Filho
• Contact: Elirez B da Silva, Doctor
• Phone: 552125997183
• Email: elirezsilva[@]ugf.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 39
• Est. completion date: August 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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.
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Brazil	Fisioprime Clinical of Physiotherapy	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Gama Filho

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	The low back pain will be assessed with numeric pain scale two times (pre and post-intervention).	up to 8 weeks	No
Secondary	Body Balance	The body balance will be assessed with Wii Balance Board two times (pre and post-intervention).	up to 8 weeks	No
Secondary	Functional autonomy	The functional autonomy will be assessed with sit-to-stand test pre and post-intervention.	up to 8 weeks	No
Secondary	Mood	The mood will be assessed with Profile of Mood State (POMS) two times (pre and post-intervention)	up to 8 weeks	No