We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Resistance Training in Knee Osteoarthritis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2009 by Federal University of São Paulo.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01099371
First Posted: April 7, 2010
Last Update Posted: May 7, 2010
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.
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
Federal University of São Paulo
  Purpose

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

Condition Intervention Phase
Knee Osteoarthritis Other: exercise Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Progressive Resistance Training in Women With Knee Osteoarthritis

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Pain assessed on a 10-point numeric pain scale [ Time Frame: week 0 ]
    Scale: visual analog scale


Secondary Outcome Measures:
  • 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


  • Quality of life assessed on the SF-36 [ Time Frame: week 6 ]
    Questionnaire Short-form-36

  • Six-minute walk test [ Time Frame: week 12 ]
    To assess distance walked in 6 minutes


Estimated Enrollment: 70
Study Start Date: February 2009
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: exercise Other: exercise
progressive resistance training

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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): NCT01099371


Locations
Brazil
Federal University of Sao Paulo
Sao Paulo, SP, Brazil, 04023-062
Sponsors and Collaborators
Federal University of São Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Study Chair: Jamil Natour, PhD Federal University of São Paulo
  More Information

Responsible Party: Renata Trajano Borges e Jorge, Federal University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01099371     History of Changes
Other Study ID Numbers: FDAAAA
First Submitted: April 1, 2010
First Posted: April 7, 2010
Last Update Posted: May 7, 2010
Last Verified: January 2009

Keywords provided by Federal University of São Paulo:
Knee
Osteoarthritis
Exercise

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases