Resistance Training in Knee Osteoarthritis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Federal University of São Paulo.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01099371
First received: April 1, 2010
Last updated: May 6, 2010
Last verified: January 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: Yes ]
    Scale: visual analog scale


Secondary Outcome Measures:
  • Disability assessed on WOMAC [ Time Frame: week 6 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]
    Questionnaire Short-form-36

  • Six-minute walk test [ Time Frame: week 12 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   40 Years to 70 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Renata Trajano Borges e Jorge, Federal University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01099371     History of Changes
Other Study ID Numbers: FDAAAA
Study First Received: April 1, 2010
Last Updated: May 6, 2010
Health Authority: Brazil: Ethics Committee

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

ClinicalTrials.gov processed this record on July 10, 2014