NCT04691258

Brief Summary

Summary: Low back pain is the leading cause of deficiency and loss of productivity worldwide. No evidence of any particular exercise was more effective than another for treating nonspecific low back pain. Objective: To evaluate the efficacy of two resistance training protocols, with different techniques for performing lower limbs exercises, in improving vertebral posture and reducing symptoms of low back pain. Methods: Randomized parallel clinical trial with two arms: Restricted Group (GR) performed all squat and Stiff exercises with neutral vertebral posture and the Complete Group (CG) performed the same exercises prioritizing the complete range of motion. Both groups had a 12-week intervention with 36 resistance training sessions. This study was conducted between November 2020 and April 2021 in Goiás (Brazil). Thirty-two participants aged 18 to 69 years with nonspecific low back pain were recruited in the extension project of the Faculty of Physical Education and Dance of the Federal University of Goiás (UFG), at the Hospital das Clínicas - UFG and at the Campos Samambaia Health Center. To ensure blindness, participants did not know why the technique of movement between them was different. The movement technique was monitored by one teacher per participant throughout the training and cannot be altered by participants at risk of compromising the results. Spinal posture was evaluated by three-dimensional reconstruction and posture quantification using dynamic posture software and pain symptoms were evaluated by the Brief Pain Inventory and Rolland Morris Questionnaire. Statistical analysis was performed in the Software SPSS and MATLAB. The Shapiro-Wilk and Bartlett tests were used to confirm the normal distribution and similar variances in the distribution of the data. The other quantitative and qualitative variables were analyzed by nonparametric statistical methods. Quantitative data with normal distribution were reported by means of means and standard deviation, minimum and maximum values, and the other data by median, interquartile range, minimum and maximum values. The pre-intervention conditions of the groups were compared by independent t-test. Two-way ANOVAs (groups X time) were used for group intervention effect comparisons for quantitative data variables with normal distribution. Significance level of 5%. The size of the effect of the results will be calculated using cohen's test.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable low-back-pain

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

November 30, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 31, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

October 4, 2021

Status Verified

September 1, 2021

Enrollment Period

4 months

First QC Date

November 26, 2020

Last Update Submit

September 27, 2021

Conditions

Keywords

low back painsquat exercisevertebral posturedeep squatresistence trainingrange of motionbackachespinevisceral obesityphysical exerciseflexibility

Outcome Measures

Primary Outcomes (2)

  • Change in Low Back Pain

    The Brief Pain Inventory will be applied, which measure pain intensity on a scale

    week 12 (change from baseline to week 12)

  • Change in Vertebral Posture

    Spine posture while performing free squat exercise measured by videogrammetry

    week 12 (change from baseline to week 12)

Secondary Outcomes (5)

  • Change in Functional Physical Capacity

    week 12 (change from baseline to week 12)

  • Change in Flexibility

    week 12 (change from baseline to week 12)

  • Change in Waist circumference

    week 12 (change from baseline to week 12)

  • Change in Muscle strength

    week 12 (change from baseline to week 12)

  • Change in Knee angle

    week 12 (change from baseline to week 12)

Study Arms (2)

Restricted Group (RG)

ACTIVE COMPARATOR

Intervention with the movement technique traditional of squat exercise.

Behavioral: Active Comparator: Restricted Group

Complete Group (CG)

EXPERIMENTAL

Intervention with the squat exercise technique prioritizing the full range of motion.

Behavioral: Experimental: Complete Group

Interventions

The participants performed the squat and Stiff exercises with the maximum range of motion. In the squats, the knees were completely flirted, even if the participant could not perform the movement with neutral vertebral posture. The heels were also not supported to the ground in some participants due to lack of flexibility. It was instructed that the participants tried to perform the Squats and Stiff keeping the lumbar lordosis neutral, with the best posture they could in all training sessions, but all should perform the exercise with as much range of motion as possible. The positioning of the feet was also carefully controlled, there was no hip rotation and the distance between the lateral edges of the heels was defined as the distance between the upper iliac spines (EIAS). The direction of the knees was oriented pointing in the direction of the tip of the feet parallel throughout the cycle of the movement.

Complete Group (CG)

The conventional movement technique of the squat exercise was used, in which the participants performed with the range of motion restricted to the neutral vertebral posture, approximately 90º of movement of the knee joint. may increase the range of motion if the lumbar posture did not rectify. The positioning of the feet in this group was carefully controlled, the participants performed the exercise with the joints of the hips abducted and rotated laterally. Having markings on the ground as a reference, the feet went rotated at 21º and the lateral edge of the heels were moved away from each other, approximately with the biacromial distance. The direction of the knees was oriented pointing in the direction of the tip of the feet throughout the cycle of the movement, aligned to the lateral rotation of the hip. In the first training session, with the aid of a goniometer and metric tape, adhesive marks were placed on the floor to ensure this positioning of the support base.

Restricted Group (RG)

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults and older adults with back pain and able to practice regular physical exercise.

You may not qualify if:

  • Recent myocardial infarction (less than three months)
  • Recent (less than three months) or disabling stroke
  • Congestive heart failure
  • Chronic kidney failure
  • Decompensated Diabetes
  • Any other disease or limitation that could compromise the performance of physical exercise protocols.
  • Participants who perform other resistance exercise activities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Centro de Saúde Campus Samambaia

Goiânia, Goiás, 74005010, Brazil

Location

Hospital das Clinicas

Goiânia, Goiás, 74605020, Brazil

Location

Faculdade de Educacao Fisica e Danca - UFG

Goiânia, Goiás, 746909000, Brazil

Location

MeSH Terms

Conditions

Low Back PainObesity, AbdominalSpinal DiseasesBack PainMotor Activity

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightBone DiseasesMusculoskeletal DiseasesBehavior

Study Officials

  • Mario H Campos, PhD

    Universidade Federal de Goiás

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Physical Exercises Treatment - The participants performed the squat exercise with the maximum range of motion, even if the participant was unable to perform the movement with a neutral vertebral posture, especially in the lumbar region, which, in most cases, rounding occurs when the range of motion is imposed. The positioning of the feet in this group was also carefully controlled, for this group, there was no hip rotation and the distance between the lateral edges of the heels was defined as the distance between the antero-superior iliac spines (ISIS). The direction of the knees was oriented pointing in the direction of the toes parallel during the whole cycle of the movement.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, Master Degree Student

Study Record Dates

First Submitted

November 26, 2020

First Posted

December 31, 2020

Study Start

November 30, 2020

Primary Completion

March 30, 2021

Study Completion

April 30, 2021

Last Updated

October 4, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

There is not a plan to make IPD available.

Locations