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Progressive Resistance Exercise in Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Control group
Experimental group
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid arthritis, Progressive resistance exercise, Pain, Functional capacity, Quality of life, Muscle strength

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universidade Federal de Sao Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

Experimental group

Arm Description

Patient remain with their usual clinical treatment.

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.

Outcomes

Primary Outcome Measures

Change in pain - Visual analogue scale

Secondary Outcome Measures

Change in function capacity - Health Assessment questionaire
Change in quality of life - Short form 36
Change in strength - 1 maximum repetition

Full Information

First Posted
August 13, 2014
Last Updated
August 12, 2016
Sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02219022
Brief Title
Progressive Resistance Exercise in Rheumatoid Arthritis
Official Title
Progressive Resistance Exercise in Rheumatoid Arthritis Patients: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid arthritis, Progressive resistance exercise, Pain, Functional capacity, Quality of life, Muscle strength

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Patient remain with their usual clinical treatment.
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Control group
Other Intervention Name(s)
Clinical tretament
Intervention Type
Other
Intervention Name(s)
Experimental group
Primary Outcome Measure Information:
Title
Change in pain - Visual analogue scale
Time Frame
baseline, 6, 12 and 24 weeks
Secondary Outcome Measure Information:
Title
Change in function capacity - Health Assessment questionaire
Time Frame
Baseline, after 6, 12 and 24 weeks
Title
Change in quality of life - Short form 36
Time Frame
baseline, after 6, 12 and 24 weeks
Title
Change in strength - 1 maximum repetition
Time Frame
baseline, after 6, 12 and 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Universidade Federal de Sao Paulo
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04023-900
Country
Brazil

12. IPD Sharing Statement

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Progressive Resistance Exercise in Rheumatoid Arthritis

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