Authors
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Universidade do Estado do Rio de Janeiro -More
Category
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Primary study
Registry of Trials»Brazilian Registry of Clinical Trials
Year
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2018
INTERVENTION: E02.190.204 E02.760.169.063.500.387 G01.374.930 H02.403.680 Whole body vibration exercise (WBVE), Auriculotherapy, auriculotherapy association with WBVE, placebo control. Whole body vibration exercise protocol: There will be 10 sessions, 02 times per week, totaling 05 weeks of protocol. The oscillating/vibrating platform (OVP) used is of the alternating type. In order to obtain adequate chair height and knee flexion in the sitting posture, an initial study will be performed using a digital accelerometer. Individuals will be guided by the evaluators, to sit in a chair, with their feet propped at the base of the OVP, arms outstretched and hands on their knees. The base of the OVP will be previously marked in 3 positions for placing the feet of the participants. These positions correspond to 3 different peak‐to‐peak displacements (D) (Position 1 ‐ D = 2.5 mm, position 2 ‐ D = 5 mm and position 3 ‐ D = 7.5 mm). The frequency will vary from 5 to 14 Hz. The total intervention time will be 11 min divided into 3 sets of 3 minutes with 1 minute rest between them. An opaque board shall be attached to the OVP display so that the participant does not identify the time and frequency used. The Evaluator will follow all procedures and will guide the participant to report any discomfort that occurs during the WBVE. In the event of any discomfort or discomfort on the part of the participant, the procedure will be automatically terminated. Protocol of auriculoterapia: A tape with two seeds will be placed on the points to be stimulated in both ears (Knee, Kidney and Shenmen point). The tapes will be changed once a week. All participants will be asked to stimulate points at least 3 times a day. a) Control Group placebo (GC)(n=50): Seedless tapes will be affixed on the same points as the treatment protocol. The participant will remain in the sitting position with the feet in the OVP for the same period of the treatment protocol, but the OVP will be turned off. b) Auriculotherapy Group (GAT)(n=50): A tape with 2 mustard CONDITION: C05.550 Gonarthrosis, knee Joint Diseases, ; C05.550 ; M17 M00‐M99 PRIMARY OUTCOME: Decreased pain level; verified through visual analogue scale (VAS); At least a 20% reduction in pain level is expected. Improvement of postural control, mobility and balance; verified through the; Time Up and Go Test (TUG);; a reduction in test run time of at least 5% between pre‐ and post‐intervention is expected, and maintenance of follow‐up improvement (7 and 14 days after the last session) is expected.; SECONDARY OUTCOME: Analysis of the response of the organism to the interventions; verified through changes in blood parameters; it is hoped to analyze the changes to understand the physiological effect of whole‐body vibration exercises between pre and post intervention. ; Change in the temperature of the skin of the lower limbs; measured by a thermogagnetic camera; it is expected to analyze changes in skin temperature during whole body vibration exercises to understand the effect of mechanical vibrations on the body. Decreased "fear of falling"; verified through the Falls Efficacy Scale (FES‐I) questionnaire; an improvement of at least 5% between pre‐ and post‐intervention is expected, and maintenance of improvement at follow‐up (7 and 14 days after the last session) is expected. ; INCLUSION CRITERIA: Individuals over 18 years of age with Knee osteoarthritis or healthy (no chronic diseases or lesions in lower limbs). ; Improved flexibility; through anterior trunk flexion; it is expected to decrease the distance between the middle finger and the floor by at least 5% between pre and post intervention and maintenance of improvement at follow up (7 and 14 days after the last session). Improvement in sleep quality; verified by the Pittsburgh Sleep Quality Index and Epworth Sleepiness Scale; an improvement of at least 5% between pre‐ and post‐intervention is expected, and maintenance of improvement at follow‐up (7 and 14 days after the last session) is expected. ; Improvement of body composition; verified through bioimpedance; an improvement of at least 5% between pre‐ and post‐intervention is expected, and maintenance of improvement at follow‐up (7 and 14 days after the last session) is expected. Improvement of the knee range of motion, measured bilaterally with a digital Goniometer; angulation of active knee flexion is expected to increase by at least 5% between pre and post intervention and maintenance of improvement at follow up (7 and 14 days after the last session). Improvement of the quality of life; verified by means of the Western Ontario and McMaster Universities questionnaires Osteoarthritis Index of Osteoarthritis (WOMAC), Medical Outcomes Study 36 ‐ Item Short‐Form Health Survey (SF‐36) and Knee Injury Osteoarthritis Outcome Score ‐ KOOS; an improvement of at least 15% between pre‐ and post‐intervention and maintenance of improvement at follow‐up (7 and 14 days after the last session) is expected. ; Improvement of the recruitment of muscle fibers of the lower limbs; verified by electromyographic tracing of the medial, anterior tibial, and vastus lateralis (bilateral, medial gastrocnemius muscles; an improvement of at least 5% between pre‐ and post‐intervention is expected and maintenance of improvement at follow up (7 and 14 days after the last session). ; Increased functional capacity of lower limbs; verified through the Lequesne Index, Lysholm knee Scoring Scale and Short Physical Performance Battery (SPPB); an improvement of at least 5% between pre‐ and post‐intervention is expected, and maintenance of improvement at follow‐up (7 and 14 days after the last session) is expected. ; Increased handgrip strength (HS); verified through the Manual Strength Dynamometer; a HS increase of at least 10% between pre‐ and post‐intervention and maintenance of improvement at follow‐up (7 and 14 days after the last session) is expected.
Epistemonikos ID: 9c6cbc62b4a461ac9cc35c3b0f9ba287f0650dfe
First added on: Aug 24, 2024