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Resistance Training in Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
exercise
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Knee, Osteoarthritis, Exercise

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Federal University of Sao Paulo

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

exercise

Arm Description

Outcomes

Primary Outcome Measures

Pain assessed on a 10-point numeric pain scale
Scale: visual analog scale

Secondary Outcome Measures

Disability assessed on WOMAC
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
Questionnaire Short-form-36
Six-minute walk test
To assess distance walked in 6 minutes

Full Information

First Posted
April 1, 2010
Last Updated
May 6, 2010
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
NCT01099371
Brief Title
Resistance Training in Knee Osteoarthritis
Official Title
Progressive Resistance Training in Women With Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Unknown status
Study Start Date
February 2009 (undefined)
Primary Completion Date
February 2009 (Anticipated)
Study Completion Date
February 2011 (Anticipated)

3. Sponsor/Collaborators

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
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether: Progressive resistance training improves pain and disability Progressive Resistance training improves muscular strength, ability to walk and quality of life
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Knee, Osteoarthritis, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
exercise
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
exercise
Intervention Description
progressive resistance training
Primary Outcome Measure Information:
Title
Pain assessed on a 10-point numeric pain scale
Description
Scale: visual analog scale
Time Frame
week 0
Secondary Outcome Measure Information:
Title
Disability assessed on WOMAC
Description
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
Time Frame
week 6
Title
Quality of life assessed on the SF-36
Description
Questionnaire Short-form-36
Time Frame
week 6
Title
Six-minute walk test
Description
To assess distance walked in 6 minutes
Time Frame
week 12

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamil Natour, PhD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
Federal University of Sao Paulo
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04023-062
Country
Brazil

12. IPD Sharing Statement

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Resistance Training in Knee Osteoarthritis

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