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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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REBEC |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
RBR-2qxmd9 |
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Date of registration:
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25/09/2011 |
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Primary sponsor: |
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Public title:
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Strengthening exercises for strength and ability to manipulate objects in people with rheumatoid arthritis in the hands.
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Scientific title:
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Strengthening exercises for hand muscles to increase strength and improve functionality in individuals with rheumatoid arthritis hand deformities. |
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Date of first enrolment:
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01/07/2010 |
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Target sample size:
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30 |
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Recruitment status: |
data analysis completed |
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URL:
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http://www.ensaiosclinicos.gov.br/rg/RBR-2qxmd9/ |
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Study type:
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Study design:
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Clinical trial, randomized, non-blind trial, double-arm
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Daniela
Abreu |
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Address:
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Avenida Bandeirantes, 3900 Faculdade de Medicina de Ribeirão Preto - USP
14049900
Ribeirão Preto
Brazil |
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Telephone:
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1636023058 |
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Email:
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dabreu@fmrp.usp.br |
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Affiliation:
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Universidade de São Paulo - Faculdade de Medicina de RibeirãoPreo |
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Name:
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Daniela
Abreu |
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Address:
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Avenida Bandeirantes, 3900 Faculdade de Medicina de Ribeirão Preto - USP
14049900
Ribeirão Preto
Brazil |
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Telephone:
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1636023058 |
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Email:
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dabreu@fmrp.usp.br |
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Affiliation:
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Universidade de São Paulo - Faculdade de Medicina de RibeirãoPreo |
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Key inclusion & exclusion criteria
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Inclusion criteria: Women diagnosed with rheumatoid arthritis and presenting deformity in at least one of the fingers of each hand participated voluntarily in the present study. Each hand should present at least one of the following deformities: swan neck, boutonniere finger and Z-shaped thumb. Deformities as bouchard's nodules and ulnar deviation should be obligatorily present in both hands.
Exclusion criteria: Women presenting other rheumatoid arthritis -related diseases and/or who entered the exacerbation phase (symptoms of inflammation in the hand joints) during the experimental time were excluded from the study.
Age minimum:
37Y
Age maximum:
0
Gender:
F
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Health Condition(s) or Problem(s) studied
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Rheumatoid arthritis C05.550.114.154
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Intervention(s)
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The study was divided into 2 groups: Intervention Group and Control Group. The Intervention Group performed a rehabilitation protocol which consisted of exercises to strengthen the force of intrinsic muscles of wrists and hands. The exercises were performed twice a week for two consecutive months, totalizing 20 sessions. The supervised exercises were performed by the patient in sitting position with her feet kept on the floor, followed by a series of exercises beginning with both free and motor coordination tasks. Next, strengthening exercises were performed with both hands by means of Digiflex hand exerciser, modeling mass, and elastics, with each session lasting 35 minutes on average. Both intensity and load of the strengthening exercises were increased every three weeks by adding repetitions to each series and adjusting the Digiflex load depending on the individual capacity of each patient. All patients with interphalangeal ortheses were encouraged to perform the exercises using them. The subjects of intervention group were also given a primer showing how to make the exercises at home, once a day for three days a week. These at-home exercises were not performed at the same day as the supervised sessions. Group Control consisted of women who received no type of treatment for improving palmar prehension during two and half consecutive months. For both groups, the subjects were instructed to keep their habitual daily activities.
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Primary Outcome(s)
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Measurement of handgrip strength using a dynamometer JAMAR and pinch strength using a dynamometer Preston Pinch Gauge, at (Kgf) scale. The handgrip strengths in the dominant and non-dominant hands were measured with the subjects seated on a chair, hips and knees flexed at 90o, feet kept on the floor, upper limbs in adduction position, elbows at 90o, and wrists in neutral position. The pinch strength (PS) was measured for both hands in which four different pinch tasks with digit pulps were performed: the first pinch movement involved index finger and thumb (PS1); the second involved third finger and thumb (PS2); the third involved fourth finger and thumb (PS3); and the fourth involved fifth finger and thumb (PS4). Each woman performed three sustained contractions for 6 seconds, with a 30-second rest interval between each contraction for both handgrip and pinch strengths evaluations. A mean value was obtained from the three measurements. All evaluations were made by only one examiner. The intervention group was re-evaluated after 10 and 20 physiotherapy sessions . The controle group was re-evaluated after 2 and half months.
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Secondary Outcome(s)
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Health Assessment Questionnaire (HAQ) was performed for assessment of the functional capacity of all women. HAQ is composed of questions on daily activities, general impact, occupational impact, and symptom intensity. The HAQ score ranges from 0 to 3, where zero means no debility and 3 means severe debility.
The intervention group was evaluated at the beginning and re-evaluated after 10 and 20 physiotherapy sessions . The controle group was re-evaluated after 2 and half months.
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The Short-Form 36 Medical Outcomes Study (SF36) questionnaires were used to evaluate the quality of life of all women. Both groups were evaluated at the beginning and at the end of the study .
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Secondary ID(s)
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número do protocolo 6053/2010
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Source(s) of Monetary Support
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Fundação de Ensino a Pesquisa do Estado de São Paulo - FAPESP - Brazil
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Hospital de Clínicas da Faculdade de Medicina de Ribeirão Preto - Brazil
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