NCT02219022

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4 rheumatoid-arthritis

Timeline
Completed

Started Jul 2011

Typical duration for phase_4 rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

August 13, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 18, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

August 15, 2016

Status Verified

August 1, 2016

Enrollment Period

3.9 years

First QC Date

August 13, 2014

Last Update Submit

August 12, 2016

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritisProgressive resistance exercisePainFunctional capacityQuality of lifeMuscle strength

Outcome Measures

Primary Outcomes (1)

  • Change in pain - Visual analogue scale

    baseline, 6, 12 and 24 weeks

Secondary Outcomes (3)

  • Change in function capacity - Health Assessment questionaire

    Baseline, after 6, 12 and 24 weeks

  • Change in quality of life - Short form 36

    baseline, after 6, 12 and 24 weeks

  • Change in strength - 1 maximum repetition

    baseline, after 6, 12 and 24 weeks

Study Arms (2)

Control group

ACTIVE COMPARATOR

Patient remain with their usual clinical treatment.

Other: Control group

Experimental group

EXPERIMENTAL

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 groupOther: Experimental group

Interventions

Control groupOTHER
Also known as: Clinical tretament
Control groupExperimental group
Experimental groupOTHER
Experimental group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal de Sao Paulo

São Paulo, São Paulo, 04023-900, Brazil

Location

MeSH Terms

Conditions

Arthritis, RheumatoidPain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT

Study Record Dates

First Submitted

August 13, 2014

First Posted

August 18, 2014

Study Start

July 1, 2011

Primary Completion

June 1, 2015

Study Completion

October 1, 2015

Last Updated

August 15, 2016

Record last verified: 2016-08

Locations

BR(1)