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
65 participants
INTERVENTIONAL
2018-07-02
2019-12-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Strategies for Patients With Osteoarthritis, by Using Assistive Technology and Exercises.
NCT03173989
Tele-rehabilitation in Knee Osteo Arthritis
NCT06430242
Influence of Using Physical Therapy Resources for Knee Osteoarthritis
NCT02636764
Efficacy of a Digital Biofeedback System for Home-based Rehabilitation After Total Joint Replacement
NCT03648060
Photobiomodulation Therapy to Reduce Pain and Inflammation in Patients With Gonarthrosis
NCT05975957
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Methods/Design
1. Participants after being textually and verbally informed about their rights, benefits and possible risks, objectives and methodologies of this study, all participants will sign a free and informed consent form.
2. Study Design Prior to the rehabilitation protocol (RP), participants will perform one adaptation session to all the functional tests that will be applied to minimize learning bias. In the second session after 5 minutes warm up in a cycle ergometer (CEE), the Time Up and Go (TUG) test will be applied, followed by the isometric strength test. In the third day, after the same warm up, one repetition maximum testing will be conducted. At the end of the RP, all the tests will be repeated. Blood samples will be collected at baseline (day 0), 1 month (day 30 after RP) and at 2 months (day 60 after RP).
2.1. Rehabilitation protocol (RP) The RP will consist of 3 exercise session/week for 8 weeks. Each session will begin with the evaluation of pain by the participants. If the pain is higher than four, an analgesic protocol (AP) containing ultra-sound, laser or transcutaneous electrical nerve stimulation (TENS) will be applied. After the AP, the participant will just execute the rehabilitation protocol if the pain decreased to or lower than four. Starting with a warm up exercise in a cycle ergometer (CEE), for 5 minutes at free cadence, then the intensity will be set at 90% of the intensity obtained during the incremental test (see item 2.2a) and maintained for 10 min. Afterward, four sets (8-12 repetitions) of three different resistance exercises (RE) (leg press, knee extension and knee flexion) will be performed at 70% of the load correspondent to 1RM test (see item 2.2b) with one minute interval between sets and exercises. During CEE Borg scale will be taken every two minutes and during RE the omnibus (OMNI) scale taken at the end of every set to monitor the intensity. At the end of the session, cool down global stretching exercises for inferior members will be performed and the VAS evaluated again. Ten seconds of tension for each stretching position targeting the hamstrings, quadriceps, gluteus maxim ums, gastrocnemius, thigh adductors and abductors.
2.2. Rehabilitation intensity parameters.
1. Cycle ergometer incremental test (CEEIT). After 5 minutes warm up at free cadence in a cycle ergometer, the intensity will be increased every 3 minutes until the participants register 11 to 13 in Borg scale which is consider a moderate intensity and to be correlated to blood lactate concentration threshold and anaerobic threshold, respectively .
2. One repetition maximum. The test starts with a warm up of 5 to 10 repetitions with estimated moderate load (± 40-60% of 1RM). After 1 minute rest 3 to 5 repetitions are performed with higher load (±60-80% of 1RM) with 5 minutes rest. Then one attempt at estimated 1RM is given. If the participants fail to lift the load for two repetitions the test stops, otherwise after 5 minutes rest the load is increased and the test is performed again. Only five attempts per day are permitted to maintain the test reliable.
Sample size calculation The estimation of sample size was determined on the basis of a greater improvement of subscale physical function of the WOMAC score, using G.Power 3.15 software. Based on 10% expected difference between baseline measure and after RP and a standard deviation of 30 on physical function of WOMAC, 65 participants are needed with significance level of 0.05, and power of 80%.
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.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Rehabilitation
The rehabilitation protocol will consist of three exercise session/week for eight weeks
Rehabilitation
Protocol will consist of three exercise/week for eight weeks. Each session will begin with the evaluation of pain by the volunteer. Starting with a warm up exercise in a cycle ergometer (CEE), for 5 minutes at free cadence, then the intensity will be set at 90% of the intensity obtained during the incremental test and maintained for 10 min. Afterward, four sets of three different resistance exercises (RE) will be performed at 70% of the load correspondent to 1RM test with one minute interval between sets and exercises. During CEE Borg scale will be taken every two minutes and during RE the OMNI scale taken at the end of every set to monitor the intensity. At the end of the session, cool down global stretching exercises for inferior members will be performed and the VAS evaluated.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Rehabilitation
Protocol will consist of three exercise/week for eight weeks. Each session will begin with the evaluation of pain by the volunteer. Starting with a warm up exercise in a cycle ergometer (CEE), for 5 minutes at free cadence, then the intensity will be set at 90% of the intensity obtained during the incremental test and maintained for 10 min. Afterward, four sets of three different resistance exercises (RE) will be performed at 70% of the load correspondent to 1RM test with one minute interval between sets and exercises. During CEE Borg scale will be taken every two minutes and during RE the OMNI scale taken at the end of every set to monitor the intensity. At the end of the session, cool down global stretching exercises for inferior members will be performed and the VAS evaluated.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Clinical knee osteoarthritis according to the American College of Rheumatology Clinical Criteria
* Kellgren and Lawrence (KL) radiographic osteoarthritis grade 2 and 3 (mild to moderate radiographic osteoarthritis)
Exclusion Criteria
* Other known major musculoskeletal impairments in the lower extremities or the back or prostheses in any joint of the lower extremities
* Known serious coronary heart diseases or cancer
* Body mass index \>35
* Scheduled for surgery in any joint
* Persons who already perform sports related moderate physical activity more than two times a week
* History of knee replacement surgery or high tibial osteotomy;
* Any knee surgery or corticosteroid injections within the previous 6 months;
* Miss more than two rehabilitation sessions during the program or more than two consecutive sessions.
45 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ohio State University
OTHER
Federal University of São Paulo
OTHER
Hospital Israelita Albert Einstein
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mario Ferretti, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Israelita Albert Einstein
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Universidade Federal de Sao Paulo
São Paulo, São Paulo, Brazil
Hospital Israelita Albert Einstein
São Paulo, São Paulo, Brazil
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Weinstein SL, Jacobs JJ, Goldberg MJ. Osteoarthritis of the knee. N Engl J Med. 2006 Jun 8;354(23):2508-9; author reply 2508-9. doi: 10.1056/NEJMc060815. No abstract available.
Kapoor M, Martel-Pelletier J, Lajeunesse D, Pelletier JP, Fahmi H. Role of proinflammatory cytokines in the pathophysiology of osteoarthritis. Nat Rev Rheumatol. 2011 Jan;7(1):33-42. doi: 10.1038/nrrheum.2010.196. Epub 2010 Nov 30.
Cross M, Smith E, Hoy D, Nolte S, Ackerman I, Fransen M, Bridgett L, Williams S, Guillemin F, Hill CL, Laslett LL, Jones G, Cicuttini F, Osborne R, Vos T, Buchbinder R, Woolf A, March L. The global burden of hip and knee osteoarthritis: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014 Jul;73(7):1323-30. doi: 10.1136/annrheumdis-2013-204763. Epub 2014 Feb 19.
McAlindon TE, Bannuru RR, Sullivan MC, Arden NK, Berenbaum F, Bierma-Zeinstra SM, Hawker GA, Henrotin Y, Hunter DJ, Kawaguchi H, Kwoh K, Lohmander S, Rannou F, Roos EM, Underwood M. OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthritis Cartilage. 2014 Mar;22(3):363-88. doi: 10.1016/j.joca.2014.01.003. Epub 2014 Jan 24.
Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage. 2008 Feb;16(2):137-62. doi: 10.1016/j.joca.2007.12.013.
Altman R, Asch E, Bloch D, Bole G, Borenstein D, Brandt K, Christy W, Cooke TD, Greenwald R, Hochberg M, et al. Development of criteria for the classification and reporting of osteoarthritis. Classification of osteoarthritis of the knee. Diagnostic and Therapeutic Criteria Committee of the American Rheumatism Association. Arthritis Rheum. 1986 Aug;29(8):1039-49. doi: 10.1002/art.1780290816.
Hsueh MF, Onnerfjord P, Kraus VB. Biomarkers and proteomic analysis of osteoarthritis. Matrix Biol. 2014 Oct;39:56-66. doi: 10.1016/j.matbio.2014.08.012. Epub 2014 Aug 30.
Kraus VB, Blanco FJ, Englund M, Henrotin Y, Lohmander LS, Losina E, Onnerfjord P, Persiani S. OARSI Clinical Trials Recommendations: Soluble biomarker assessments in clinical trials in osteoarthritis. Osteoarthritis Cartilage. 2015 May;23(5):686-97. doi: 10.1016/j.joca.2015.03.002.
Terada C, Yoshida A, Nasu Y, Mori S, Tomono Y, Tanaka M, Takahashi HK, Nishibori M, Ozaki T, Nishida K. Gene expression and localization of high-mobility group box chromosomal protein-1 (HMGB-1)in human osteoarthritic cartilage. Acta Med Okayama. 2011 Dec;65(6):369-77. doi: 10.18926/AMO/47262.
Hunt MA, Pollock CL, Kraus VB, Saxne T, Peters S, Huebner JL, Sayre EC, Cibere J. Relationships amongst osteoarthritis biomarkers, dynamic knee joint load, and exercise: results from a randomized controlled pilot study. BMC Musculoskelet Disord. 2013 Mar 27;14:115. doi: 10.1186/1471-2474-14-115.
Andersson U, Harris HE. The role of HMGB1 in the pathogenesis of rheumatic disease. Biochim Biophys Acta. 2010 Jan-Feb;1799(1-2):141-8. doi: 10.1016/j.bbagrm.2009.11.003.
Imamura M, Ezquerro F, Marcon Alfieri F, Vilas Boas L, Tozetto-Mendoza TR, Chen J, Ozcakar L, Arendt-Nielsen L, Rizzo Battistella L. Serum levels of proinflammatory cytokines in painful knee osteoarthritis and sensitization. Int J Inflam. 2015;2015:329792. doi: 10.1155/2015/329792. Epub 2015 Mar 2.
Li ZC, Cheng GQ, Hu KZ, Li MQ, Zang WP, Dong YQ, Wang WL, Liu ZD. Correlation of synovial fluid HMGB-1 levels with radiographic severity of knee osteoarthritis. Clin Invest Med. 2011 Oct 1;34(5):E298. doi: 10.25011/cim.v34i5.15673.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Osteoarthritis
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.