NCT02326792

Brief 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. 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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 30, 2014

Completed
2 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

December 2, 2015

Status Verified

November 1, 2015

Enrollment Period

7 months

First QC Date

December 17, 2014

Last Update Submit

November 30, 2015

Conditions

Keywords

ExerciseTrainingLow back PainPhysical Therapy

Outcome Measures

Primary Outcomes (1)

  • 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).

    10 weeks

Secondary Outcomes (1)

  • Number of repetitions

    10 weeks

Other Outcomes (2)

  • EMG fatigue index

    10 weeks

  • Isometric strength (maximal voluntary contractio: MVC)

    10 weeks

Study Arms (3)

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.

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.

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.

Interventions

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.

G1-Three sets of exerciseG2-One set of exercise

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 19127180BACKGROUND
  • 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.

    PMID: 20508534BACKGROUND
  • 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.

    PMID: 12195070BACKGROUND

MeSH Terms

Conditions

Back PainMotor ActivityLow Back Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Rubens A DA SILVA, PhD

    Universidade Norte do Paraná

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Titular professor

Study Record Dates

First Submitted

December 17, 2014

First Posted

December 30, 2014

Study Start

January 1, 2015

Primary Completion

August 1, 2015

Study Completion

September 1, 2015

Last Updated

December 2, 2015

Record last verified: 2015-11