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Progressive Resistance Exercise in Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02219022
Recruitment Status : Completed
First Posted : August 18, 2014
Last Update Posted : August 15, 2016
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Felipe Martinelli Lourenzi, Federal University of São Paulo

Brief Summary:
A randomized controlled trial with rheumatoid arthritis patients will be realized. Patients will be randomized into two groups. Experimental group will do a 12 weeks training of progressive resistance exercise for global muscles and remain with the clinical treatment and the control only remain with the clinical treatment. Patients will be evaluated at baseline, after 6, 12 and 24 weeks.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Other: Control group Other: Experimental group Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Progressive Resistance Exercise in Rheumatoid Arthritis Patients: a Randomized Controlled Trial
Study Start Date : July 2011
Actual Primary Completion Date : June 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control group
Patient remain with their usual clinical treatment.
Other: Control group
Other Name: Clinical tretament

Experimental: Experimental group

Patients in experimental group participated in a 12-week progressive resistance training using a maximum repetition exercise in which patients performed 1 Maximum Repetition with the maximum bearable weight. Once the 1 Maximum Repetitionwas determined, training was divided into the following regimen: 2 series of 8 repetitions, the first with 50% and the second with 70% of 1 Maximum Repetition.

The exercises were knee extension and flexion and hip abduction and adduction, elbow extension and flexion, wrist extension and flexion and shoulder abduction and adduction and spine extension and flexion all performed in machines. The 1 Maximum Repetition load was reevaluated every 6 weeks.

Patient remain with their usual clinical treatment.

Other: Control group
Other Name: Clinical tretament

Other: Experimental group



Primary Outcome Measures :
  1. Change in pain - Visual analogue scale [ Time Frame: baseline, 6, 12 and 24 weeks ]

Secondary Outcome Measures :
  1. Change in function capacity - Health Assessment questionaire [ Time Frame: Baseline, after 6, 12 and 24 weeks ]
  2. Change in quality of life - Short form 36 [ Time Frame: baseline, after 6, 12 and 24 weeks ]
  3. Change in strength - 1 maximum repetition [ Time Frame: baseline, after 6, 12 and 24 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Rheumatoid arthritis according to American College of Rheumatology 2010
  • Both genders
  • Age between 18 and 65 years
  • Functional class I, II and III
  • Stable medication within the three months preceding the study
  • Haven't done any kind of regular exercise (two or more times per Week) for at least three months before study start
  • Have agreed to participate in the study and signed an informed consent form.

Exclusion Criteria:

  • Participating in another type of study
  • Have difficulty understanding the evaluation tools with fibromyalgia
  • Joint deformities that make impossible do the exercises
  • Other musculoskeletal diseases
  • Other diseases that contraindicate exercises.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02219022


Locations
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Brazil
Universidade Federal de Sao Paulo
Sao Paulo, SP, Brazil, 04023-900
Sponsors and Collaborators
Federal University of São Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
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Responsible Party: Felipe Martinelli Lourenzi, PT, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT02219022    
Other Study ID Numbers: CEP/UNIFESP 1826/10
First Posted: August 18, 2014    Key Record Dates
Last Update Posted: August 15, 2016
Last Verified: August 2016
Keywords provided by Felipe Martinelli Lourenzi, Federal University of São Paulo:
Rheumatoid arthritis
Progressive resistance exercise
Pain
Functional capacity
Quality of life
Muscle strength
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases