Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
42 participants
INTERVENTIONAL
2015-01-31
2015-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Forty-two healthy voluntaries (from 18 to 35 years) of both the sexes will participate of this study. All participants will sign an informed consent form approved by the North of Parana University Ethics Committee for Research on Human Subjects. The sample will be randomized in three groups by the allocation from printed cards sequentially numbered in opaque envelopes: (G1, n=14) the participants will perform three sets of 15-20 repetitions of the trunk extensor exercise on a roman chair machine with the hips at 45 degrees relative to horizontal; performing trunk flexion-extension cycles for a total of 4 seconds (2 s concentric and 2 s eccentric contraction); (G2) the participants will perform only one set of 15-20 repetitions of the trunk extensor exercise on a roman chair machine with the hips at 45 degrees relative to horizontal; performing also trunk flexion-extension cycles for a total of 4 seconds (2 s concentric and 2 s eccentric); and (G3) the participants will be the control group, which not participating of any exercise program in any time during the study. A total of 10 weeks of training will be performed in the study, by 2 x week with the progression of load volume (increase the load if the total repetition of 20 is reached).
Before and after the lumbar training, all participants will be assessed by the endurance muscular (Isometric Sorensen test using time-limit, Dynamic endurance using the number of repetition, Borg fatigue perception scale and EMG surface of trunk extensor muscles by computation of median frequency fatigue estimate); and by the strength muscular (back isometric maximal voluntary contraction using a dynamometer on a roman chair). An evaluator trained will perform all testing assessment, in baseline time and after weeks of training. The evaluator will be blinded with regard the groups on assessment. Also, an exercise professional of sport will be responsible by exercise prescription to prescript the training at the Fitness center in the UNOPAR University; This professional will be also blinded to the groups.
An ANOVA two-way to compare the effects in the three groups (G1, G2, and G3) and the two times session-1: baseline and session-2: after 10 weeks); and the effects of interaction (Groups X Times) also will be tested. When necessary a Tukey post hoc analysis will be performed to localize the differences on the three groups. The effect size on each group will be calculated to determine the rate of changes from the training intervention.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
G1-Three sets of exercise
G1 group - the participants will perform three sets of 15-20 repetitions of the trunk extensor exercise on a roman chair machine with the hips at 45 degrees relative to horizontal; performing trunk flexion-extension cycles for a total of 4 seconds (2 s concentric and 2 s eccentric contraction). The relative load for initial training will be placed at 20% back maximal voluntary contraction (MVC) and will be progressive during the training. The time session of training will be of 10 weeks.
Exercise
The groups will perform the trunk extensor exercise on a roman chair by 2 x week, for a total of 10 weeks of training (20 sessions). The load will be progressive and tested to each 14 days with regard to the number of repetition reached by the participant. The exercise is safe and will be supervised by a health sport professional.
G2-One set of exercise
G2 group - the participants will perform only one set of 15-20 repetitions of the trunk extensor exercise on a roman chair machine with the hips at 45 degrees relative to horizontal; performing trunk flexion-extension cycles for a total of 4 seconds (2 s concentric and 2 s eccentric contraction). The relative load for initial training will be placed at 20% back maximal voluntary contraction (MVC) and will be progressive during the training. The time session of training will be of 10 weeks.
Exercise
The groups will perform the trunk extensor exercise on a roman chair by 2 x week, for a total of 10 weeks of training (20 sessions). The load will be progressive and tested to each 14 days with regard to the number of repetition reached by the participant. The exercise is safe and will be supervised by a health sport professional.
G3-Control
G3 group - the participants will be the control group, which not participating of exercise program in any time during the study.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Exercise
The groups will perform the trunk extensor exercise on a roman chair by 2 x week, for a total of 10 weeks of training (20 sessions). The load will be progressive and tested to each 14 days with regard to the number of repetition reached by the participant. The exercise is safe and will be supervised by a health sport professional.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* All subjects need to be voluntaries.
Exclusion Criteria
* Several spinal pathologies (fractures, tumors, and inflammation), nerve root disorders (disc herniation and ,spondylolisthesis with neurological compromise, spinal stenosis, and others), several cardiorespiratory diseases, previous back surgery or pregnancy;
* Mental or physical illnesses problems that interfere with the exercise;
* Any surgery in the spine in the last 6 months;
* Upper body mass (trunk, upper limbs and head) greater than 50% of the total strength of the trunk extensor muscles from first day the data collection.
* Subjects enrolled in any exercise program outside of the study.
18 Years
35 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Universidade Estadual de Londrina
OTHER
Universidade Norte do ParanĂ¡
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Rubens Alexandre da Silva Jr
Titular professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Rubens A DA SILVA, PhD
Role: STUDY_DIRECTOR
Universidade Norte do ParanĂ¡
References
Explore related publications, articles, or registry entries linked to this study.
da Silva RA, Lariviere C, Arsenault AB, Nadeau S, Plamondon A. Pelvic stabilization and semisitting position increase the specificity of back exercises. Med Sci Sports Exerc. 2009 Feb;41(2):435-43. doi: 10.1249/MSS.0b013e318188446a.
Lariviere C, Da Silva RA, Arsenault AB, Nadeau S, Plamondon A, Vadeboncoeur R. Specificity of a back muscle roman chair exercise in healthy and back pain subjects. Med Sci Sports Exerc. 2011 Jan;43(1):157-64. doi: 10.1249/MSS.0b013e3181e96388.
Verna JL, Mayer JM, Mooney V, Pierra EA, Robertson VL, Graves JE. Back extension endurance and strength: the effect of variable-angle roman chair exercise training. Spine (Phila Pa 1976). 2002 Aug 15;27(16):1772-7. doi: 10.1097/00007632-200208150-00016.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Unopar-Rubens-2
Identifier Type: -
Identifier Source: org_study_id