Low Back PainNCT01503203
Physical Virtual Training for Older Women
A study testing Strength Training, Core training and Physical Virtual Training in people with Low Back Pain, run by Universidade Gama Filho at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 65 to 75 years, women only
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Strength Training, Core training and Physical Virtual Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2011to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 75 years
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- subjects with nonspecific chronic low back pain
- patients without involvement in regular exercise program
Who cannot join
- patients not recommended for physical exercise (Physical Activity Readiness Questionnaire PAR-Q)
- trunk surgery
- cancer
- injuries in lower extremity
- neurological or vestibular disease
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Fisioprime Clinical of Physiotherapy
Rio de Janeiro, Rio de Janeiro, 555
Renato S Monteiro Junior, Professor, 552192447872, renatoprofedfis@hotmail.com
Renato S Monteiro Junior, Professor
About this study
Official title: 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.
- Conditions
- Low Back Pain
- Being tested
- Strength Training, Core training, Physical Virtual Training
- Keywords
- Older, virtual systems, low back pain, postural balance
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength TrainingOther
Also called Resistance 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 trainingOther
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 TrainingOther
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 TrainingOther
Also called Resistance 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 TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Physical Virtual Training; Other: Strength Training; Other: Core Training |
| Prime Group | Active comparator | This group will do strength exercises and core training. Receives: Other: Strength Training; Other: Core training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
The low back pain will be assessed with numeric pain scale two times (pre and post-intervention).
Measured: up to 8 weeks
Secondary outcomes (3)
Body Balance
The body balance will be assessed with Wii Balance Board two times (pre and post-intervention).
Measured: up to 8 weeks
Functional autonomy
The functional autonomy will be assessed with sit-to-stand test pre and post-intervention.
Measured: up to 8 weeks
Mood
The mood will be assessed with Profile of Mood State (POMS) two times (pre and post-intervention)
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2012 (estimated)
- Study startNov 2011
- Primary completionApr 2012 (estimated)
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Gama Filho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renato Sobral Monteiro Junior, Universidade Gama Filho
- Investigators
- Elirez B da Silva, Doctor, Study director, Gama Filho University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01503203
- Sponsor's protocol ID
- RSMJ20112
- Status last verified
- Dec 2011
- First submitted
- 16 Dec 2011
- Last updated
- 2 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Virtual Training Effectiveness on Nonspecific Chronic Low Back Pain, Body Balance, Functional Autonomy and Mood of Older Women
- ClinicalTrials.gov ID
- NCT01503203
- Acronym / sponsor ID
- RSMJ20112
- Conditions
- Low Back Pain
- Keywords
- Older, virtual systems, low back pain, postural balance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Universidade Gama FilhoUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Apr 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 2 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wii Group | Experimental | Other: Physical Virtual Training, Other: Strength Training, Other: Core TrainingThis 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. |
| Prime Group | Active comparator | Other: Strength Training, Other: Core trainingThis group will do strength exercises and core training. |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- subjects with nonspecific chronic low back pain
- patients without involvement in regular exercise program
Key exclusion criteria (5 listed)
- patients not recommended for physical exercise (Physical Activity Readiness Questionnaire PAR-Q)
- trunk surgery
- cancer
- injuries in lower extremity
- neurological or vestibular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strength TrainingAlso: Resistance trainingIt 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 | Prime Group |
| Core trainingExercises 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. | Other | Prime Group |
| Physical Virtual TrainingThe 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 | Wii Group |
| Strength TrainingAlso: Resistance trainingIt 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 | Wii Group |
| Core TrainingExercises 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. | Other | Wii Group |
Primary outcome
Pain
Time frame: up to 8 weeks
The low back pain will be assessed with numeric pain scale two times (pre and post-intervention).
3 secondary outcomes
Body Balance
Time frame: up to 8 weeks
Functional autonomy
Time frame: up to 8 weeks
Mood
Time frame: up to 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elirez B da Silva, Doctor study director
Gama Filho University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength Training, Core training and Physical Virtual Training in people with Low Back Pain, run by Universidade Gama Filho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elirez B da Silva, Doctor (552125997183, elirezsilva@ugf.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2012.