- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03645616
Reliability of Function Tests for People With Back Pain.
Reliability of Functional Tests for Individuals With Chronic Low Back Pain.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Santa Catarina
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Araranguá, Santa Catarina, Brazil, 88.905-120
- Santa Catarina Federal University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Both sexes aged 20 to 65 years and low back pain for more than 3 months.
Exclusion Criteria:
- Acute pain of back pain that disables the performance of the tests.
- Pregnancy.
- Neoplasms.
- Known heart, lung or metabolic diseases.
- Hypotension (BP < 90 x 60 mmHg) or stage II hypertension (BP > 140 x 90 mmHg), medicated or not.
- Fall or faint in the previous two months.
- Have not undergone any spinal surgery.
- Have not had neuromuscular impairment in the last three months and who need help to follow the instructions.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Functional Tests
Participants undertook 6-minute walk test, 10 meters walk test and 30 second sit to stand test.
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First day: Participants undertook 6-minute walk test. There was a 30-minute interval between the first and second test, when the patient was asked to rest. During the resting period, they respond a pain intensity, functional capacity and physical activity level questionnaire. Second day: the participants repeated the test and questionnaires. First day: After the second 6-minute walk test the participants perform the 10-meter walk test, the test must be performed three times with a 30-second interval, at the end the average test velocity. Second day: the participants repeated the test.
At the end of the tests the participants perform the 30 Second Sit to Stand Test on the first and second day.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Distance traveled in meters.
Time Frame: The individual will perform 42 minutes of testing, two walking tests of 6 minutes plus 30 minutes of rest
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Measured by the 6-minute walk test.
Individuals should walk in a 30 meter corridor for 6 uninterrupted minutes.
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The individual will perform 42 minutes of testing, two walking tests of 6 minutes plus 30 minutes of rest
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain intensity
Time Frame: 5 minutes
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Measured through the Numerical Rating Scale, being considered an improvement of pain, the reduction of 2,5 points in the NRS.
Evaluated at the beginning and after the tests.
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5 minutes
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Functional Incapacity
Time Frame: 10 minutes
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Measured using the Roland Morris functional disability questionnaire considering improvement the decrease of 2.5 points.
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10 minutes
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Physical activity level
Time Frame: 10 minutes
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The scores obtained through the International Physical Activity Questionnaire (IPAQ) are obtained through the minutes of activities performed per week, classifying the individual as very active, active, irregularly active and sedentary
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10 minutes
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Gait Speed
Time Frame: 5 minutes
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Measured through the 10 meters walk test that measures walking speed in meters per second for a short period.
Individual walks without assistance 10 meters (32.8 feet) and the time is measured for the intermediate 6 meters (19.7 feet) to allow for acceleration and deceleration.
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5 minutes
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Functional lower extremity strength
Time Frame: 30 seconds.
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Measured through the 30 Second Sit to Stand Test, which evaluates the functional limb strength with the number of sit and stand repetitions for 30 seconds.
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30 seconds.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Aline L Ballico, Student, Santa Catarina Federal University
Publications and helpful links
General Publications
- ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available. Erratum In: Am J Respir Crit Care Med. 2016 May 15;193(10):1185.
- Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
- Airaksinen O, Brox JI, Cedraschi C, Hildebrandt J, Klaber-Moffett J, Kovacs F, Mannion AF, Reis S, Staal JB, Ursin H, Zanoli G; COST B13 Working Group on Guidelines for Chronic Low Back Pain. Chapter 4. European guidelines for the management of chronic nonspecific low back pain. Eur Spine J. 2006 Mar;15 Suppl 2(Suppl 2):S192-300. doi: 10.1007/s00586-006-1072-1. No abstract available.
- Enright PL, Sherrill DL. Reference equations for the six-minute walk in healthy adults. Am J Respir Crit Care Med. 1998 Nov;158(5 Pt 1):1384-7. doi: 10.1164/ajrccm.158.5.9710086. Erratum In: Am J Respir Crit Care Med. 2020 Feb 1;201(3):393.
- Koo TK, Li MY. A Guideline of Selecting and Reporting Intraclass Correlation Coefficients for Reliability Research. J Chiropr Med. 2016 Jun;15(2):155-63. doi: 10.1016/j.jcm.2016.02.012. Epub 2016 Mar 31. Erratum In: J Chiropr Med. 2017 Dec;16(4):346.
- Chou R, Deyo R, Friedly J, Skelly A, Hashimoto R, Weimer M, Fu R, Dana T, Kraegel P, Griffin J, Grusing S, Brodt ED. Nonpharmacologic Therapies for Low Back Pain: A Systematic Review for an American College of Physicians Clinical Practice Guideline. Ann Intern Med. 2017 Apr 4;166(7):493-505. doi: 10.7326/M16-2459. Epub 2017 Feb 14.
- Britto RR, Sousa LAP. Teste de caminhada de seis minutos- Uma normatização brasileira. Fisioterapia em Movimento 19(4):49-54, 2006.
- Lamoth CJ, Meijer OG, Daffertshofer A, Wuisman PI, Beek PJ. Effects of chronic low back pain on trunk coordination and back muscle activity during walking: changes in motor control. Eur Spine J. 2006 Jan;15(1):23-40. doi: 10.1007/s00586-004-0825-y. Epub 2005 Apr 29.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2.537.100
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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