Back PainTrainingNCT02326792
Effect of Volume Training on Back Endurance
A study testing Exercise in people with Back Pain, run by Universidade Norte do Paraná.
Trial summary
The fatigue of the trunk extensor muscles is often reported in people with the chronic low back pain (LBP). Evidences have showed that the strengthening muscular by the training of the lumbar spinal muscles is efficient to decrease the pain and disability symptoms of patients with the chronic LBP. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Back Pain
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Sep 2015
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects only and not using ergogenic substances and anabolic steroids, and drugs use for increasing ot the muscular performance.
- All subjects need to be voluntaries.
Who cannot join
- Any contraindication to physical exercise performance in accord with the American College of Sports Medicine Standard Position;
- 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.
About this study
Official title: Effect of Volume Training on Endurance of Trunk Extensor Muscles in Healthy Subjects: A Randomized Control Trial.
The fatigue of the trunk extensor muscles is often reported in people with the chronic low back pain (LBP). Evidences have showed that the strengthening muscular by the training of the lumbar spinal muscles is efficient to decrease the pain and disability symptoms of patients with the chronic LBP. Also, some studies have reported improve of the strength and endurance of the back muscles from of this type of training muscular. However, the exercise prescription for the trunk extensor muscles during the training is still not clear in the literature. In fact, no study has showed any differences between one and three sets of specific lumbar exercise with regard to better prescription of training in healthy subjects (e.g; preventive action) as well as in LBP subjects (e.g; intervention action).
Read the detailed description
The purpose of this study is to compare an endurance trunk extensor training using one and three sets of exercise repetition on gains of strength and endurance muscular in healthy subjects.
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
- Back Pain
- Being tested
- Exercise
- Keywords
- Exercise, Training, Low back Pain, Physical Therapy
- Medical subject headings
- Back Pain, Motor Activity, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| G1-Three sets of exercise | Experimental | 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. Receives: Other: Exercise |
| G2-One set of exercise | Experimental | 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. Receives: Other: Exercise |
| G3-Control | No intervention | G3 group - the participants will be the control group, which not participating of exercise program in any time during the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isometric endurance (Classic Sorensen test)
To determine the improve of endurance muscular, the time-limit in seconds will be computed from modified Sorensen test executed on a roman chair. To measure the fatigue muscular, the participant would hold the unsupported trunk horizontally (Sorensen test).
Measured: 10 weeks
Secondary outcomes (1)
Number of repetitions
To determine the improve of dynamic back endurance, a second test will be performed and the number of repetitions will be computed from trunk flexion-extension cycles executed on a roman chair (2 seconds of concentric and 2 seconds of eccentric contraction; by a total of 4 seconds for each cycle).
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionAug 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Norte do Paraná
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Estadual de Londrina
- Responsible party
- Principal investigator, Rubens Alexandre da Silva Jr, Universidade Norte do Paraná
- Investigators
- Rubens A DA SILVA, PhD, Study director, Universidade Norte do Paraná
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02326792
- Sponsor's protocol ID
- Unopar-Rubens-2
- Acronym
- Training
- Status last verified
- Nov 2015
- First submitted
- 17 Dec 2014
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19127180Lariviere 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.
PubMed 20508534Verna 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.
PubMed 12195070
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Volume Training on Endurance of Trunk Extensor Muscles in Healthy Subjects: A Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT02326792
- Acronym / sponsor ID
- Training / Unopar-Rubens-2
- Conditions
- Back Pain
- Keywords
- Exercise, Training, Low back Pain, Physical Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Universidade Norte do ParanáUniversity, hospital or other
- Collaborators
- Universidade Estadual de Londrina
- Study start
- Jan 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 30 Dec 2014 (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 fatigue of the trunk extensor muscles is often reported in people with the chronic low back pain (LBP). Evidences have showed that the strengthening muscular by the training of the lumbar spinal muscles is efficient to decrease the pain and disability symptoms of patients with the chronic LBP. Also, some studies have reported improve of the strength and endurance of the back muscles from of this type of training muscular. However, the exercise prescription for the trunk extensor muscles during the training is still not clear in the literature. In fact, no study has showed any differences between one and three sets of specific lumbar exercise with regard to better prescription of training in healthy subjects (e.g; preventive action) as well as in LBP subjects (e.g; intervention action).
Detailed description
The purpose of this study is to compare an endurance trunk extensor training using one and three sets of exercise repetition on gains of strength and endurance muscular in healthy subjects.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| G1-Three sets of exercise | Experimental | Other: ExerciseG1 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. |
| G2-One set of exercise | Experimental | Other: ExerciseG2 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. |
| G3-Control | No intervention | –G3 group - the participants will be the control group, which not participating of exercise program in any time during the study. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy subjects only and not using ergogenic substances and anabolic steroids, and drugs use for increasing ot the muscular performance.
- All subjects need to be voluntaries.
Key exclusion criteria (6 listed)
- Any contraindication to physical exercise performance in accord with the American College of Sports Medicine Standard Position;
- 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.
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 |
|---|---|---|
| ExerciseThe 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. | Other | G1-Three sets of exercise, G2-One set of exercise |
Primary outcome
Isometric endurance (Classic Sorensen test)
Time frame: 10 weeks
To determine the improve of endurance muscular, the time-limit in seconds will be computed from modified Sorensen test executed on a roman chair. To measure the fatigue muscular, the participant would hold the unsupported trunk horizontally (Sorensen test).
1 secondary outcome
Number of repetitions
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
- Background: PubMed 19127180da 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.
- Background: PubMed 20508534Lariviere 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.
- Background: PubMed 12195070Verna 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.
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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.
Rubens A DA SILVA, PhD study director
Universidade Norte do Paraná
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Back Pain, run by Universidade Norte do Paraná.
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 6 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: finished, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isometric endurance (Classic Sorensen test) (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02326792, which also lists 3 linked publications.
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 Dec 2015.