Progressive Resistance Exercise in Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Progressive Resistance Exercise in Rheumatoid Arthritis Patients: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02219022
• Other study ID #: CEP/UNIFESP 1826/10
• Status: Completed
• Phase: Phase 4
• First received: August 13, 2014
• Last updated: August 12, 2016
• Start date: July 2011
• Est. completion date: October 2015

Study information

• Verified date: August 2016
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Other:
• Control group

• Experimental group

Locations

Country	Name	City	State
Brazil	Universidade Federal de Sao Paulo	Sao Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain - Visual analogue scale		baseline, 6, 12 and 24 weeks	No
Secondary	Change in function capacity - Health Assessment questionaire		Baseline, after 6, 12 and 24 weeks	No
Secondary	Change in quality of life - Short form 36		baseline, after 6, 12 and 24 weeks	No
Secondary	Change in strength - 1 maximum repetition		baseline, after 6, 12 and 24 weeks	No