Resistance Training in Knee Osteoarthritis

May 6, 2010 updated by: Federal University of São Paulo

Progressive Resistance Training in Women With Knee Osteoarthritis

The purpose of this study is to determine whether:

  1. Progressive resistance training improves pain and disability
  2. Progressive Resistance training improves muscular strength, ability to walk and quality of life

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

The exercises were knee extension and flexion and hip abduction and adduction, all performed in machines. The 1RM load was reevaluated every 2 weeks.

The control group remained on a three-month waiting list for physiotherapy. Patients were assessed for pain, function, quality of life, muscle strength and six-minute walk test.

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil, 04023-062
        • Federal University of São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Woman
  • Age between 40-70 years old
  • Pain between 3 and 8 on a 10-point numeric pain scale
  • Radiographically confirmed knee OA

Exclusion Criteria:

  • Inflammatory diseases or any comorbidity that prohibit exercises, regular physical activity
  • Trip plans for the next 12 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: exercise
Other: exercise
progressive resistance training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain assessed on a 10-point numeric pain scale
Time Frame: week 0
Scale: visual analog scale
week 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disability assessed on WOMAC
Time Frame: week 6

Western Ontario McMaster University Osteoarthritis Index Rheumatology An arthritic pain scoring system ranging from 0-no pain/disability to 100-most severe pain/disability

WOMAC-pain, WOMAC-function and WOMAC-stifness
week 6
Quality of life assessed on the SF-36
Time Frame: week 6
Questionnaire Short-form-36
week 6
Six-minute walk test
Time Frame: week 12
To assess distance walked in 6 minutes
week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

  • Study Chair: Jamil Natour, PHD, Federal University of São Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Anticipated)

February 1, 2009

Study Completion (Anticipated)

February 1, 2011

Study Registration Dates

First Submitted

April 1, 2010

First Submitted That Met QC Criteria

April 5, 2010

First Posted (Estimate)

April 7, 2010

Study Record Updates

Last Update Posted (Estimate)

May 7, 2010

Last Update Submitted That Met QC Criteria

May 6, 2010

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDAAAA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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